FDA FAERS Adverse Event Reports

110500
Total Reports
60546
Serious Reports
108
Reporter Countries
Clear
25971187 Type 1
Serious
OXYCODONE HYDROCHLORIDE
Report Version
1
Receive Date
10/28/2025
Receipt Date
10/28/2025
Transmission Date
01/17/2026
Primary Source Country
CN
Occurrence Country
CN
Reporter Country
CN
Reporter Qualification
Other Health Professional
Literature Reference
--
Company Number
CN-NAPPMUNDI-GBR-2025-0129894
Authority Number
--
Sender Organization
PURDUE
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
68.0 yr
Patient Age Group
--
Patient Sex
Male
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (5)

Upper gastrointestinal haemorrhage (v28.1) Recovering
Tinnitus (v28.1) Unknown
Decreased appetite (v28.1) Unknown
Vomiting (v28.1) Recovering
Asthenia (v28.1) Unknown

Drugs (1)

OXYCODONE HYDROCHLORIDE (OXYCODONE HYDROCHLORIDE) Suspect
Route: 048 | Dosage: 30 MILLIGRAM, BID | Form: Prolonged-release tablet | Indication: Analgesic therapy | Action: Withdrawn
Auth#: 022272 | Batch#: 265754 | Structured Dosage: 60.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 10/17/2025 | End: 10/17/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: Yes
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20251017

Report Duplicates (2)

NAPPMUNDI: CN-NAPPMUNDI-GBR-2025-0129894
Reg Auth China: 5114021025228202500252

Raw JSON (click to expand)

{ "_id": "69974fbd8e900fe3f48c5e9b", "safetyreportid": "25971187", "authoritynumb": null, "companynumb": "CN-NAPPMUNDI-GBR-2025-0129894", "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "CN", "patient": { "patientonsetage": 68.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": null, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Upper gastrointestinal haemorrhage", "reactionoutcome": 2 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Tinnitus", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Decreased appetite", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Vomiting", "reactionoutcome": 2 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Asthenia", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "OXYCODONE HYDROCHLORIDE", "drugauthorizationnumb": "022272", "drugbatchnumb": "265754", "drugstructuredosagenumb": 60.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "30 MILLIGRAM, BID", "drugdosageform": "Prolonged-release tablet", "drugadministrationroute": "048", "drugindication": "Analgesic therapy", "drugstartdateformat": "102", "drugstartdate": "2025-10-17T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-10-17T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "OXYCODONE HYDROCHLORIDE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20251017" }, "primarysource": { "reportercountry": "CN", "qualification": 3, "literaturereference": null }, "primarysourcecountry": "CN", "quarter": "2025Q4", "receiptdate": "2025-10-28T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-28T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "NAPPMUNDI", "duplicatenumb": "CN-NAPPMUNDI-GBR-2025-0129894" }, { "duplicatesource": "Reg Auth China", "duplicatenumb": "5114021025228202500252" } ], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "PURDUE" }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 1, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-17T00:00:00", "transmissiondateformat": "102" }
25971186 Type 1
Serious
OCTREOTIDE ACETATE, OCTREOTIDE ACETATE, OCTREOTIDE ACETATE (+1 more)
Report Version
1
Receive Date
10/28/2025
Receipt Date
10/28/2025
Transmission Date
01/17/2026
Primary Source Country
CN
Occurrence Country
CN
Reporter Country
CN
Reporter Qualification
Other Health Professional
Literature Reference
Junwei L, Lulin X, Haitao C, Ting J, Yan L. ??????????????? 1 ? [A case of recurrent acute pancreatitis caused by sodium valproate]. CHINESE JOURNAL OF HOSPITAL PHARMACY. 1-5
Company Number
CN-002147023-NVSC2025CN164206
Authority Number
--
Sender Organization
NOVARTIS
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
36.0 yr
Patient Age Group
--
Patient Sex
Male
Patient Weight
65.0 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Abdominal pain upper (v28.1) Unknown
Off label use (v28.1) Unknown

Drugs (4)

OCTREOTIDE ACETATE (OCTREOTIDE ACETATE) Suspect
Route: 065 | Dosage: 0.1 MG, Q8H | Form: Injection | Indication: Pancreatitis acute | Action: Unknown
Auth#: 21008 | Batch#: -- | Structured Dosage: 0.1 (unit: 003) | Separate Dosage#: 1.0 | Interval: 8.0 hr | Cumulative: 1.8 (unit: 003)
Start: 05/17/2024 | End: 05/22/2024 | Duration: 6.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
OCTREOTIDE ACETATE (OCTREOTIDE ACETATE) Suspect
Route: -- | Dosage: -- | Form: Injection | Indication: -- | Action: Unknown
Auth#: 21008 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: 1.8 (unit: 003)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
OCTREOTIDE ACETATE (OCTREOTIDE ACETATE) Suspect
Route: -- | Dosage: -- | Form: Injection | Indication: -- | Action: Unknown
Auth#: 21008 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: 1.8 (unit: 003)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
ULINASTATIN (ULINASTATIN) Suspect
Route: 065 | Dosage: 100000 UNITS, Q8H | Form: Injection | Indication: Pancreatitis acute | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: 8.0 hr | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20240517

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69974fbd8e900fe3f48c5e9a", "safetyreportid": "25971186", "authoritynumb": null, "companynumb": "CN-002147023-NVSC2025CN164206", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "CN", "patient": { "patientonsetage": 36.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": 65.0, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Abdominal pain upper", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Off label use", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "OCTREOTIDE ACETATE", "drugauthorizationnumb": "21008", "drugbatchnumb": null, "drugstructuredosagenumb": 0.1, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 8.0, "drugintervaldosagedefinition": 805, "drugcumulativedosagenumb": 1.8, "drugcumulativedosageunit": "003", "drugdosagetext": "0.1 MG, Q8H", "drugdosageform": "Injection", "drugadministrationroute": "065", "drugindication": "Pancreatitis acute", "drugstartdateformat": "102", "drugstartdate": "2024-05-17T00:00:00", "drugenddateformat": "102", "drugenddate": "2024-05-22T00:00:00", "drugtreatmentduration": 6.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "OCTREOTIDE ACETATE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "OCTREOTIDE ACETATE", "drugauthorizationnumb": "21008", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": 1.8, "drugcumulativedosageunit": "003", "drugdosagetext": null, "drugdosageform": "Injection", "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "OCTREOTIDE ACETATE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "OCTREOTIDE ACETATE", "drugauthorizationnumb": "21008", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": 1.8, "drugcumulativedosageunit": "003", "drugdosagetext": null, "drugdosageform": "Injection", "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "OCTREOTIDE ACETATE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "ULINASTATIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 8.0, "drugintervaldosagedefinition": 805, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "100000 UNITS, Q8H", "drugdosageform": "Injection", "drugadministrationroute": "065", "drugindication": "Pancreatitis acute", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "ULINASTATIN" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20240517" }, "primarysource": { "reportercountry": "CN", "qualification": 3, "literaturereference": "Junwei L, Lulin X, Haitao C, Ting J, Yan L. ??????????????? 1 ? [A case of recurrent acute pancreatitis caused by sodium valproate]. CHINESE JOURNAL OF HOSPITAL PHARMACY. 1-5" }, "primarysourcecountry": "CN", "quarter": "2025Q4", "receiptdate": "2025-10-28T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-28T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "NOVARTIS" }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 1, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-17T00:00:00", "transmissiondateformat": "102" }
25971185 Type 1
Serious
EVEROLIMUS, EVEROLIMUS
Report Version
1
Receive Date
10/28/2025
Receipt Date
10/28/2025
Transmission Date
01/18/2026
Primary Source Country
CN
Occurrence Country
CN
Reporter Country
CN
Reporter Qualification
Other Health Professional
Literature Reference
Huang X, Liu X, Huang R. ? ? ? ? ? ? ? ? ? ? ? ? ? ? T F E 3 ? ? 1 ? [One case: renal epithelioid angiomyolipoma with TFE3 translocation]. J PRACT RADIOL. 2024;40 (4):684-5
Company Number
CN-002147023-NVSC2025CN164791
Authority Number
--
Sender Organization
NOVARTIS
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
28.0 yr
Patient Age Group
--
Patient Sex
Male
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Metastases to bone (v28.1) Unknown
Back pain (v28.1) Unknown

Drugs (2)

EVEROLIMUS (EVEROLIMUS) Suspect
Route: 065 | Dosage: UNK | Form: -- | Indication: Renal cancer | Action: Unknown
Auth#: 22334 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
EVEROLIMUS (EVEROLIMUS) Suspect
Route: -- | Dosage: -- | Form: -- | Indication: Metastases to bone | Action: Unknown
Auth#: 22334 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69974fbd8e900fe3f48c5e99", "safetyreportid": "25971185", "authoritynumb": null, "companynumb": "CN-002147023-NVSC2025CN164791", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "CN", "patient": { "patientonsetage": 28.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": null, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Metastases to bone", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Back pain", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "EVEROLIMUS", "drugauthorizationnumb": "22334", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": "Renal cancer", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "EVEROLIMUS" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "EVEROLIMUS", "drugauthorizationnumb": "22334", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Metastases to bone", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "EVEROLIMUS" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "CN", "qualification": 3, "literaturereference": "Huang X, Liu X, Huang R. ? ? ? ? ? ? ? ? ? ? ? ? ? ? T F E 3 ? ? 1 ? [One case: renal epithelioid angiomyolipoma with TFE3 translocation]. J PRACT RADIOL. 2024;40 (4):684-5" }, "primarysourcecountry": "CN", "quarter": "2025Q4", "receiptdate": "2025-10-28T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-28T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "NOVARTIS" }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 1, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-18T00:00:00", "transmissiondateformat": "102" }
25971184 Type 1
Non-Serious
PLEGRIDY
Report Version
1
Receive Date
10/28/2025
Receipt Date
10/28/2025
Transmission Date
01/19/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Consumer
Literature Reference
--
Company Number
US-BIOGEN-2025BI01326852
Authority Number
--
Sender Organization
BIOGEN
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
No
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
--
Patient Age Group
--
Patient Sex
Female
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Drug dose omission by device (v28.1) Not Recovered
Drug delivery system malfunction (v28.1) Unknown

Drugs (1)

PLEGRIDY (PEGINTERFERON BETA-1A) Suspect
Route: -- | Dosage: -- | Form: Solution for injection | Indication: Product used for unknown indication | Action: Unknown
Auth#: 125499 | Batch#: SH0690 | Structured Dosage: 125.0 (unit: 004) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Unknown
Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69974fbd8e900fe3f48c5e97", "safetyreportid": "25971184", "authoritynumb": null, "companynumb": "US-BIOGEN-2025BI01326852", "duplicate": null, "fulfillexpeditecriteria": 2, "occurcountry": "US", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Drug dose omission by device", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Drug delivery system malfunction", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "PLEGRIDY", "drugauthorizationnumb": "125499", "drugbatchnumb": "SH0690", "drugstructuredosagenumb": 125.0, "drugstructuredosageunit": "004", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Solution for injection", "drugadministrationroute": null, "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "PEGINTERFERON BETA-1A" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "US", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-28T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-28T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "BIOGEN" }, "serious": 2, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-19T00:00:00", "transmissiondateformat": "102" }
25971181 Type 1
Serious
CLOZARIL, CLOZARIL, CLOZARIL (+5 more)
Report Version
1
Receive Date
10/28/2025
Receipt Date
10/28/2025
Transmission Date
01/17/2026
Primary Source Country
AU
Occurrence Country
AU
Reporter Country
AU
Reporter Qualification
Other Health Professional
Literature Reference
--
Company Number
AU-MYLANLABS-2025M1090371
Authority Number
--
Sender Organization
MYLAN
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
29.0 yr
Patient Age Group
--
Patient Sex
Female
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Hospitalisation (v28.1) Unknown
Thrombocytosis (v28.1) Unknown

Drugs (8)

CLOZARIL (CLOZAPINE) Suspect
Route: -- | Dosage: 500 MILLIGRAM | Form: -- | Indication: Schizophrenia | Action: Unknown
Auth#: 075417 | Batch#: -- | Structured Dosage: 500.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
CLOZARIL (CLOZAPINE) Suspect
Route: 048 | Dosage: 500 MILLIGRAM | Form: -- | Indication: -- | Action: Unknown
Auth#: 075417 | Batch#: -- | Structured Dosage: 500.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
CLOZARIL (CLOZAPINE) Suspect
Route: 048 | Dosage: 500 MILLIGRAM | Form: -- | Indication: -- | Action: Unknown
Auth#: 075417 | Batch#: -- | Structured Dosage: 500.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
CLOZARIL (CLOZAPINE) Suspect
Route: -- | Dosage: 500 MILLIGRAM | Form: -- | Indication: -- | Action: Unknown
Auth#: 075417 | Batch#: -- | Structured Dosage: 500.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
KETAMINE (KETAMINE) Concomitant
Route: -- | Dosage: UNK (INFUSION) | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
KETAMINE (KETAMINE) Concomitant
Route: 065 | Dosage: UNK (INFUSION) | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
KETAMINE (KETAMINE) Concomitant
Route: 065 | Dosage: UNK (INFUSION) | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
KETAMINE (KETAMINE) Concomitant
Route: -- | Dosage: UNK (INFUSION) | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20251001

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69974fbd8e900fe3f48c5e96", "safetyreportid": "25971181", "authoritynumb": null, "companynumb": "AU-MYLANLABS-2025M1090371", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "AU", "patient": { "patientonsetage": 29.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Hospitalisation", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Thrombocytosis", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "CLOZARIL", "drugauthorizationnumb": "075417", "drugbatchnumb": null, "drugstructuredosagenumb": 500.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "500 MILLIGRAM", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Schizophrenia", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "CLOZAPINE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "CLOZARIL", "drugauthorizationnumb": "075417", "drugbatchnumb": null, "drugstructuredosagenumb": 500.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "500 MILLIGRAM", "drugdosageform": null, "drugadministrationroute": "048", "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "CLOZAPINE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "CLOZARIL", "drugauthorizationnumb": "075417", "drugbatchnumb": null, "drugstructuredosagenumb": 500.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "500 MILLIGRAM", "drugdosageform": null, "drugadministrationroute": "048", "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "CLOZAPINE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "CLOZARIL", "drugauthorizationnumb": "075417", "drugbatchnumb": null, "drugstructuredosagenumb": 500.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "500 MILLIGRAM", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "CLOZAPINE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "KETAMINE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK (INFUSION)", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "KETAMINE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "KETAMINE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK (INFUSION)", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "KETAMINE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "KETAMINE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK (INFUSION)", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "KETAMINE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "KETAMINE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK (INFUSION)", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "KETAMINE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20251001" }, "primarysource": { "reportercountry": "AU", "qualification": 3, "literaturereference": null }, "primarysourcecountry": "AU", "quarter": "2025Q4", "receiptdate": "2025-10-28T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-28T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "MYLAN" }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 1, "seriousnesslifethreatening": 2, "seriousnessother": 1, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-17T00:00:00", "transmissiondateformat": "102" }
25971180 Type 1
Non-Serious
VRAYLAR
Report Version
1
Receive Date
10/28/2025
Receipt Date
10/28/2025
Transmission Date
01/17/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Physician
Literature Reference
--
Company Number
US-ABBVIE-6520797
Authority Number
--
Sender Organization
ABBVIE
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
No
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
50.0 yr
Patient Age Group
--
Patient Sex
--
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Tremor (v28.1) Unknown

Drugs (1)

VRAYLAR (CARIPRAZINE) Suspect
Route: 048 | Dosage: 1.5 MILLIGRAM | Form: -- | Indication: Major depression | Action: Unknown
Auth#: 204370 | Batch#: -- | Structured Dosage: 1.5 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69974fbd8e900fe3f48c5e95", "safetyreportid": "25971180", "authoritynumb": null, "companynumb": "US-ABBVIE-6520797", "duplicate": null, "fulfillexpeditecriteria": 2, "occurcountry": "US", "patient": { "patientonsetage": 50.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": null, "patientsex": null, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Tremor", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "VRAYLAR", "drugauthorizationnumb": "204370", "drugbatchnumb": null, "drugstructuredosagenumb": 1.5, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "1.5 MILLIGRAM", "drugdosageform": null, "drugadministrationroute": "048", "drugindication": "Major depression", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "CARIPRAZINE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "US", "qualification": 1, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-28T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-28T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "ABBVIE" }, "serious": 2, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-17T00:00:00", "transmissiondateformat": "102" }
25971165 Type 1
Serious
METOPROLOL, METOPROLOL, METOPROLOL (+37 more)
Report Version
1
Receive Date
10/28/2025
Receipt Date
10/28/2025
Transmission Date
01/17/2026
Primary Source Country
EU
Occurrence Country
EU
Reporter Country
EU
Reporter Qualification
Physician
Literature Reference
--
Company Number
EU-EMB-M202401936-1
Authority Number
--
Sender Organization
MYLAN
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
--
Patient Age Group
--
Patient Sex
Female
Patient Weight
1.88 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (5)

Small for dates baby (v28.1) Recovered
Bradycardia neonatal (v28.1) Recovered
Infantile apnoea (v28.1) Recovered
Neonatal hypoxia (v28.1) Recovered
Foetal exposure during pregnancy (v28.1) Unknown

Drugs (40)

METOPROLOL (METOPROLOL) Suspect
Route: 064 | Dosage: UNTIL APPROXIMATELY GW 11 | Form: -- | Indication: Arrhythmia | Action: Not Applicable
Auth#: 076704 | Batch#: -- | Structured Dosage: 95.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 12/01/2023 | End: 02/01/2024 | Duration: 78.0 day | Rechallenge: -- | Additional: 4
Recurrences: --
METOPROLOL (METOPROLOL) Suspect
Route: -- | Dosage: UNTIL APPROXIMATELY GW 11 | Form: -- | Indication: -- | Action: Not Applicable
Auth#: 076704 | Batch#: -- | Structured Dosage: 95.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 12/01/2023 | End: 02/01/2024 | Duration: 78.0 day | Rechallenge: -- | Additional: 4
Recurrences: --
METOPROLOL (METOPROLOL) Suspect
Route: -- | Dosage: UNTIL APPROXIMATELY GW 11 | Form: -- | Indication: -- | Action: Not Applicable
Auth#: 076704 | Batch#: -- | Structured Dosage: 95.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 12/01/2023 | End: 02/01/2024 | Duration: 78.0 day | Rechallenge: -- | Additional: 4
Recurrences: --
METOPROLOL (METOPROLOL) Suspect
Route: 064 | Dosage: UNTIL APPROXIMATELY GW 11 | Form: -- | Indication: -- | Action: Not Applicable
Auth#: 076704 | Batch#: -- | Structured Dosage: 95.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 12/01/2023 | End: 02/01/2024 | Duration: 78.0 day | Rechallenge: -- | Additional: 4
Recurrences: --
METOPROLOL (METOPROLOL) Suspect
Route: -- | Dosage: UNTIL APPROXIMATELY GW 11 | Form: -- | Indication: -- | Action: Not Applicable
Auth#: 076704 | Batch#: -- | Structured Dosage: 95.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 12/01/2023 | End: 02/01/2024 | Duration: 78.0 day | Rechallenge: -- | Additional: 4
Recurrences: --
METOPROLOL (METOPROLOL) Suspect
Route: -- | Dosage: UNTIL APPROXIMATELY GW 11 | Form: -- | Indication: -- | Action: Not Applicable
Auth#: 076704 | Batch#: -- | Structured Dosage: 95.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 12/01/2023 | End: 02/01/2024 | Duration: 78.0 day | Rechallenge: -- | Additional: 4
Recurrences: --
METOPROLOL (METOPROLOL) Suspect
Route: 064 | Dosage: UNTIL APPROXIMATELY GW 11 | Form: -- | Indication: -- | Action: Not Applicable
Auth#: 076704 | Batch#: -- | Structured Dosage: 95.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 12/01/2023 | End: 02/01/2024 | Duration: 78.0 day | Rechallenge: -- | Additional: 4
Recurrences: --
METOPROLOL (METOPROLOL) Suspect
Route: 064 | Dosage: UNTIL APPROXIMATELY GW 11 | Form: -- | Indication: -- | Action: Not Applicable
Auth#: 076704 | Batch#: -- | Structured Dosage: 95.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 12/01/2023 | End: 02/01/2024 | Duration: 78.0 day | Rechallenge: -- | Additional: 4
Recurrences: --
METOPROLOL (METOPROLOL) Suspect
Route: 064 | Dosage: REDUCED DOSAGE: 142.5 MG/D (1/2-0-1) FROM APPROXIMATELY GW 11 TO 32 | Form: -- | Indication: -- | Action: Not Applicable
Auth#: 076704 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 02/01/2024 | End: 07/01/2024 | Duration: 147.0 day | Rechallenge: -- | Additional: 4
Recurrences: --
METOPROLOL (METOPROLOL) Suspect
Route: -- | Dosage: REDUCED DOSAGE: 142.5 MG/D (1/2-0-1) FROM APPROXIMATELY GW 11 TO 32 | Form: -- | Indication: -- | Action: Not Applicable
Auth#: 076704 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 02/01/2024 | End: 07/01/2024 | Duration: 147.0 day | Rechallenge: -- | Additional: 4
Recurrences: --
METOPROLOL (METOPROLOL) Suspect
Route: -- | Dosage: REDUCED DOSAGE: 142.5 MG/D (1/2-0-1) FROM APPROXIMATELY GW 11 TO 32 | Form: -- | Indication: -- | Action: Not Applicable
Auth#: 076704 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 02/01/2024 | End: 07/01/2024 | Duration: 147.0 day | Rechallenge: -- | Additional: 4
Recurrences: --
METOPROLOL (METOPROLOL) Suspect
Route: 064 | Dosage: REDUCED DOSAGE: 142.5 MG/D (1/2-0-1) FROM APPROXIMATELY GW 11 TO 32 | Form: -- | Indication: -- | Action: Not Applicable
Auth#: 076704 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 02/01/2024 | End: 07/01/2024 | Duration: 147.0 day | Rechallenge: -- | Additional: 4
Recurrences: --
METOPROLOL (METOPROLOL) Suspect
Route: 064 | Dosage: REDUCED DOSAGE: 142.5 MG/D (1/2-0-1) FROM APPROXIMATELY GW 11 TO 32 | Form: -- | Indication: -- | Action: Not Applicable
Auth#: 076704 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 02/01/2024 | End: 07/01/2024 | Duration: 147.0 day | Rechallenge: -- | Additional: 4
Recurrences: --
METOPROLOL (METOPROLOL) Suspect
Route: 064 | Dosage: REDUCED DOSAGE: 142.5 MG/D (1/2-0-1) FROM APPROXIMATELY GW 11 TO 32 | Form: -- | Indication: -- | Action: Not Applicable
Auth#: 076704 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 02/01/2024 | End: 07/01/2024 | Duration: 147.0 day | Rechallenge: -- | Additional: 4
Recurrences: --
METOPROLOL (METOPROLOL) Suspect
Route: -- | Dosage: REDUCED DOSAGE: 142.5 MG/D (1/2-0-1) FROM APPROXIMATELY GW 11 TO 32 | Form: -- | Indication: -- | Action: Not Applicable
Auth#: 076704 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 02/01/2024 | End: 07/01/2024 | Duration: 147.0 day | Rechallenge: -- | Additional: 4
Recurrences: --
METOPROLOL (METOPROLOL) Suspect
Route: -- | Dosage: REDUCED DOSAGE: 142.5 MG/D (1/2-0-1) FROM APPROXIMATELY GW 11 TO 32 | Form: -- | Indication: -- | Action: Not Applicable
Auth#: 076704 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 02/01/2024 | End: 07/01/2024 | Duration: 147.0 day | Rechallenge: -- | Additional: 4
Recurrences: --
METOPROLOL (METOPROLOL) Suspect
Route: -- | Dosage: FURTHER REDUCTION TO 95 MG/D (1/2-0-1/2) FROM GW 32 UNTIL DELIVERY | Form: -- | Indication: -- | Action: Not Applicable
Auth#: 076704 | Batch#: -- | Structured Dosage: 47.5 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 07/01/2024 | End: 08/01/2024 | Duration: 29.0 day | Rechallenge: -- | Additional: 4
Recurrences: --
METOPROLOL (METOPROLOL) Suspect
Route: -- | Dosage: FURTHER REDUCTION TO 95 MG/D (1/2-0-1/2) FROM GW 32 UNTIL DELIVERY | Form: -- | Indication: -- | Action: Not Applicable
Auth#: 076704 | Batch#: -- | Structured Dosage: 47.5 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 07/01/2024 | End: 08/01/2024 | Duration: 29.0 day | Rechallenge: -- | Additional: 4
Recurrences: --
METOPROLOL (METOPROLOL) Suspect
Route: 064 | Dosage: FURTHER REDUCTION TO 95 MG/D (1/2-0-1/2) FROM GW 32 UNTIL DELIVERY | Form: -- | Indication: -- | Action: Not Applicable
Auth#: 076704 | Batch#: -- | Structured Dosage: 47.5 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 07/01/2024 | End: 08/01/2024 | Duration: 29.0 day | Rechallenge: -- | Additional: 4
Recurrences: --
METOPROLOL (METOPROLOL) Suspect
Route: 064 | Dosage: FURTHER REDUCTION TO 95 MG/D (1/2-0-1/2) FROM GW 32 UNTIL DELIVERY | Form: -- | Indication: -- | Action: Not Applicable
Auth#: 076704 | Batch#: -- | Structured Dosage: 47.5 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 07/01/2024 | End: 08/01/2024 | Duration: 29.0 day | Rechallenge: -- | Additional: 4
Recurrences: --
METOPROLOL (METOPROLOL) Suspect
Route: -- | Dosage: FURTHER REDUCTION TO 95 MG/D (1/2-0-1/2) FROM GW 32 UNTIL DELIVERY | Form: -- | Indication: -- | Action: Not Applicable
Auth#: 076704 | Batch#: -- | Structured Dosage: 47.5 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 07/01/2024 | End: 08/01/2024 | Duration: 29.0 day | Rechallenge: -- | Additional: 4
Recurrences: --
METOPROLOL (METOPROLOL) Suspect
Route: -- | Dosage: FURTHER REDUCTION TO 95 MG/D (1/2-0-1/2) FROM GW 32 UNTIL DELIVERY | Form: -- | Indication: -- | Action: Not Applicable
Auth#: 076704 | Batch#: -- | Structured Dosage: 47.5 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 07/01/2024 | End: 08/01/2024 | Duration: 29.0 day | Rechallenge: -- | Additional: 4
Recurrences: --
METOPROLOL (METOPROLOL) Suspect
Route: 064 | Dosage: FURTHER REDUCTION TO 95 MG/D (1/2-0-1/2) FROM GW 32 UNTIL DELIVERY | Form: -- | Indication: -- | Action: Not Applicable
Auth#: 076704 | Batch#: -- | Structured Dosage: 47.5 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 07/01/2024 | End: 08/01/2024 | Duration: 29.0 day | Rechallenge: -- | Additional: 4
Recurrences: --
METOPROLOL (METOPROLOL) Suspect
Route: 064 | Dosage: FURTHER REDUCTION TO 95 MG/D (1/2-0-1/2) FROM GW 32 UNTIL DELIVERY | Form: -- | Indication: -- | Action: Not Applicable
Auth#: 076704 | Batch#: -- | Structured Dosage: 47.5 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 07/01/2024 | End: 08/01/2024 | Duration: 29.0 day | Rechallenge: -- | Additional: 4
Recurrences: --
DUPIXENT (DUPILUMAB) Concomitant
Route: -- | Dosage: UNTIL APPROXIMATELY GW 11 | Form: -- | Indication: Neurodermatitis | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 300.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 2.0 wk | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 5.0 day | Rechallenge: -- | Additional: --
Recurrences: --
DUPIXENT (DUPILUMAB) Concomitant
Route: -- | Dosage: UNTIL APPROXIMATELY GW 11 | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 300.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 2.0 wk | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 5.0 day | Rechallenge: -- | Additional: --
Recurrences: --
DUPIXENT (DUPILUMAB) Concomitant
Route: 064 | Dosage: UNTIL APPROXIMATELY GW 11 | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 300.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 2.0 wk | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 5.0 day | Rechallenge: -- | Additional: --
Recurrences: --
DUPIXENT (DUPILUMAB) Concomitant
Route: 064 | Dosage: UNTIL APPROXIMATELY GW 11 | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 300.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 2.0 wk | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 5.0 day | Rechallenge: -- | Additional: --
Recurrences: --
DUPIXENT (DUPILUMAB) Concomitant
Route: -- | Dosage: UNTIL APPROXIMATELY GW 11 | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 300.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 2.0 wk | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 5.0 day | Rechallenge: -- | Additional: --
Recurrences: --
DUPIXENT (DUPILUMAB) Concomitant
Route: -- | Dosage: UNTIL APPROXIMATELY GW 11 | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 300.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 2.0 wk | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 5.0 day | Rechallenge: -- | Additional: --
Recurrences: --
DUPIXENT (DUPILUMAB) Concomitant
Route: 064 | Dosage: UNTIL APPROXIMATELY GW 11 | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 300.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 2.0 wk | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 5.0 day | Rechallenge: -- | Additional: --
Recurrences: --
DUPIXENT (DUPILUMAB) Concomitant
Route: 064 | Dosage: UNTIL APPROXIMATELY GW 11 | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 300.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 2.0 wk | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 5.0 day | Rechallenge: -- | Additional: --
Recurrences: --
BOOSTRIX (TETANUS TOXOID, REDUCED DIPHTHERIA TOXOID AND ACELLULAR PERTUSSIS VACCINE ADSORBED, TDAP) Concomitant
Route: -- | Dosage: UNK | Form: -- | Indication: Immunisation | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 07/01/2024 | End: 07/01/2024 | Duration: 1.0 day | Rechallenge: -- | Additional: --
Recurrences: --
BOOSTRIX (TETANUS TOXOID, REDUCED DIPHTHERIA TOXOID AND ACELLULAR PERTUSSIS VACCINE ADSORBED, TDAP) Concomitant
Route: -- | Dosage: UNK | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 07/01/2024 | End: 07/01/2024 | Duration: 1.0 day | Rechallenge: -- | Additional: --
Recurrences: --
BOOSTRIX (TETANUS TOXOID, REDUCED DIPHTHERIA TOXOID AND ACELLULAR PERTUSSIS VACCINE ADSORBED, TDAP) Concomitant
Route: 064 | Dosage: UNK | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 07/01/2024 | End: 07/01/2024 | Duration: 1.0 day | Rechallenge: -- | Additional: --
Recurrences: --
BOOSTRIX (TETANUS TOXOID, REDUCED DIPHTHERIA TOXOID AND ACELLULAR PERTUSSIS VACCINE ADSORBED, TDAP) Concomitant
Route: 064 | Dosage: UNK | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 07/01/2024 | End: 07/01/2024 | Duration: 1.0 day | Rechallenge: -- | Additional: --
Recurrences: --
BOOSTRIX (TETANUS TOXOID, REDUCED DIPHTHERIA TOXOID AND ACELLULAR PERTUSSIS VACCINE ADSORBED, TDAP) Concomitant
Route: -- | Dosage: UNK | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 07/01/2024 | End: 07/01/2024 | Duration: 1.0 day | Rechallenge: -- | Additional: --
Recurrences: --
BOOSTRIX (TETANUS TOXOID, REDUCED DIPHTHERIA TOXOID AND ACELLULAR PERTUSSIS VACCINE ADSORBED, TDAP) Concomitant
Route: -- | Dosage: UNK | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 07/01/2024 | End: 07/01/2024 | Duration: 1.0 day | Rechallenge: -- | Additional: --
Recurrences: --
BOOSTRIX (TETANUS TOXOID, REDUCED DIPHTHERIA TOXOID AND ACELLULAR PERTUSSIS VACCINE ADSORBED, TDAP) Concomitant
Route: 064 | Dosage: UNK | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 07/01/2024 | End: 07/01/2024 | Duration: 1.0 day | Rechallenge: -- | Additional: --
Recurrences: --
BOOSTRIX (TETANUS TOXOID, REDUCED DIPHTHERIA TOXOID AND ACELLULAR PERTUSSIS VACCINE ADSORBED, TDAP) Concomitant
Route: 064 | Dosage: UNK | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 07/01/2024 | End: 07/01/2024 | Duration: 1.0 day | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20240801

Report Duplicates (1)

BFARM: EU-BFARM-25007289

Raw JSON (click to expand)

{ "_id": "69974fbd8e900fe3f48c5e94", "safetyreportid": "25971165", "authoritynumb": null, "companynumb": "EU-EMB-M202401936-1", "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "EU", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": 1.88, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Small for dates baby", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Bradycardia neonatal", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Infantile apnoea", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Neonatal hypoxia", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Foetal exposure during pregnancy", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "METOPROLOL", "drugauthorizationnumb": "076704", "drugbatchnumb": null, "drugstructuredosagenumb": 95.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNTIL APPROXIMATELY GW 11", "drugdosageform": null, "drugadministrationroute": "064", "drugindication": "Arrhythmia", "drugstartdateformat": "610", "drugstartdate": "2023-12-01T00:00:00", "drugenddateformat": "610", "drugenddate": "2024-02-01T00:00:00", "drugtreatmentduration": 78.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "METOPROLOL" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "METOPROLOL", "drugauthorizationnumb": "076704", "drugbatchnumb": null, "drugstructuredosagenumb": 95.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNTIL APPROXIMATELY GW 11", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": "610", "drugstartdate": "2023-12-01T00:00:00", "drugenddateformat": "610", "drugenddate": "2024-02-01T00:00:00", "drugtreatmentduration": 78.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "METOPROLOL" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "METOPROLOL", "drugauthorizationnumb": "076704", "drugbatchnumb": null, "drugstructuredosagenumb": 95.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNTIL APPROXIMATELY GW 11", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": "610", "drugstartdate": "2023-12-01T00:00:00", "drugenddateformat": "610", "drugenddate": "2024-02-01T00:00:00", "drugtreatmentduration": 78.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "METOPROLOL" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "METOPROLOL", "drugauthorizationnumb": "076704", "drugbatchnumb": null, "drugstructuredosagenumb": 95.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNTIL APPROXIMATELY GW 11", "drugdosageform": null, "drugadministrationroute": "064", "drugindication": null, "drugstartdateformat": "610", "drugstartdate": "2023-12-01T00:00:00", "drugenddateformat": "610", "drugenddate": "2024-02-01T00:00:00", "drugtreatmentduration": 78.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "METOPROLOL" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "METOPROLOL", "drugauthorizationnumb": "076704", "drugbatchnumb": null, "drugstructuredosagenumb": 95.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNTIL APPROXIMATELY GW 11", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": "610", "drugstartdate": "2023-12-01T00:00:00", "drugenddateformat": "610", "drugenddate": "2024-02-01T00:00:00", "drugtreatmentduration": 78.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "METOPROLOL" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "METOPROLOL", "drugauthorizationnumb": "076704", "drugbatchnumb": null, "drugstructuredosagenumb": 95.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNTIL APPROXIMATELY GW 11", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": "610", "drugstartdate": "2023-12-01T00:00:00", "drugenddateformat": "610", "drugenddate": "2024-02-01T00:00:00", "drugtreatmentduration": 78.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "METOPROLOL" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "METOPROLOL", "drugauthorizationnumb": "076704", "drugbatchnumb": null, "drugstructuredosagenumb": 95.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNTIL APPROXIMATELY GW 11", "drugdosageform": null, "drugadministrationroute": "064", "drugindication": null, "drugstartdateformat": "610", "drugstartdate": "2023-12-01T00:00:00", "drugenddateformat": "610", "drugenddate": "2024-02-01T00:00:00", "drugtreatmentduration": 78.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "METOPROLOL" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "METOPROLOL", "drugauthorizationnumb": "076704", "drugbatchnumb": null, "drugstructuredosagenumb": 95.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNTIL APPROXIMATELY GW 11", "drugdosageform": null, "drugadministrationroute": "064", "drugindication": null, "drugstartdateformat": "610", "drugstartdate": "2023-12-01T00:00:00", "drugenddateformat": "610", "drugenddate": "2024-02-01T00:00:00", "drugtreatmentduration": 78.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "METOPROLOL" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "METOPROLOL", "drugauthorizationnumb": "076704", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "REDUCED DOSAGE: 142.5 MG/D (1/2-0-1) FROM APPROXIMATELY GW 11 TO 32", "drugdosageform": null, "drugadministrationroute": "064", "drugindication": null, "drugstartdateformat": "610", "drugstartdate": "2024-02-01T00:00:00", "drugenddateformat": "610", "drugenddate": "2024-07-01T00:00:00", "drugtreatmentduration": 147.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "METOPROLOL" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "METOPROLOL", "drugauthorizationnumb": "076704", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "REDUCED DOSAGE: 142.5 MG/D (1/2-0-1) FROM APPROXIMATELY GW 11 TO 32", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": "610", "drugstartdate": "2024-02-01T00:00:00", "drugenddateformat": "610", "drugenddate": "2024-07-01T00:00:00", "drugtreatmentduration": 147.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "METOPROLOL" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "METOPROLOL", "drugauthorizationnumb": "076704", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "REDUCED DOSAGE: 142.5 MG/D (1/2-0-1) FROM APPROXIMATELY GW 11 TO 32", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": "610", "drugstartdate": "2024-02-01T00:00:00", "drugenddateformat": "610", "drugenddate": "2024-07-01T00:00:00", "drugtreatmentduration": 147.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "METOPROLOL" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "METOPROLOL", "drugauthorizationnumb": "076704", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "REDUCED DOSAGE: 142.5 MG/D (1/2-0-1) FROM APPROXIMATELY GW 11 TO 32", "drugdosageform": null, "drugadministrationroute": "064", "drugindication": null, "drugstartdateformat": "610", "drugstartdate": "2024-02-01T00:00:00", "drugenddateformat": "610", "drugenddate": "2024-07-01T00:00:00", "drugtreatmentduration": 147.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "METOPROLOL" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "METOPROLOL", "drugauthorizationnumb": "076704", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "REDUCED DOSAGE: 142.5 MG/D (1/2-0-1) FROM APPROXIMATELY GW 11 TO 32", "drugdosageform": null, "drugadministrationroute": "064", "drugindication": null, "drugstartdateformat": "610", "drugstartdate": "2024-02-01T00:00:00", "drugenddateformat": "610", "drugenddate": "2024-07-01T00:00:00", "drugtreatmentduration": 147.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "METOPROLOL" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "METOPROLOL", "drugauthorizationnumb": "076704", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "REDUCED DOSAGE: 142.5 MG/D (1/2-0-1) FROM APPROXIMATELY GW 11 TO 32", "drugdosageform": null, "drugadministrationroute": "064", "drugindication": null, "drugstartdateformat": "610", "drugstartdate": "2024-02-01T00:00:00", "drugenddateformat": "610", "drugenddate": "2024-07-01T00:00:00", "drugtreatmentduration": 147.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "METOPROLOL" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "METOPROLOL", "drugauthorizationnumb": "076704", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "REDUCED DOSAGE: 142.5 MG/D (1/2-0-1) FROM APPROXIMATELY GW 11 TO 32", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": "610", "drugstartdate": "2024-02-01T00:00:00", "drugenddateformat": "610", "drugenddate": "2024-07-01T00:00:00", "drugtreatmentduration": 147.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "METOPROLOL" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "METOPROLOL", "drugauthorizationnumb": "076704", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "REDUCED DOSAGE: 142.5 MG/D (1/2-0-1) FROM APPROXIMATELY GW 11 TO 32", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": "610", "drugstartdate": "2024-02-01T00:00:00", "drugenddateformat": "610", "drugenddate": "2024-07-01T00:00:00", "drugtreatmentduration": 147.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "METOPROLOL" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "METOPROLOL", "drugauthorizationnumb": "076704", "drugbatchnumb": null, "drugstructuredosagenumb": 47.5, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "FURTHER REDUCTION TO 95 MG/D (1/2-0-1/2) FROM GW 32 UNTIL DELIVERY", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": "610", "drugstartdate": "2024-07-01T00:00:00", "drugenddateformat": "610", "drugenddate": "2024-08-01T00:00:00", "drugtreatmentduration": 29.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "METOPROLOL" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "METOPROLOL", "drugauthorizationnumb": "076704", "drugbatchnumb": null, "drugstructuredosagenumb": 47.5, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "FURTHER REDUCTION TO 95 MG/D (1/2-0-1/2) FROM GW 32 UNTIL DELIVERY", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": "610", "drugstartdate": "2024-07-01T00:00:00", "drugenddateformat": "610", "drugenddate": "2024-08-01T00:00:00", "drugtreatmentduration": 29.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "METOPROLOL" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "METOPROLOL", "drugauthorizationnumb": "076704", "drugbatchnumb": null, "drugstructuredosagenumb": 47.5, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "FURTHER REDUCTION TO 95 MG/D (1/2-0-1/2) FROM GW 32 UNTIL DELIVERY", "drugdosageform": null, "drugadministrationroute": "064", "drugindication": null, "drugstartdateformat": "610", "drugstartdate": "2024-07-01T00:00:00", "drugenddateformat": "610", "drugenddate": "2024-08-01T00:00:00", "drugtreatmentduration": 29.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "METOPROLOL" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "METOPROLOL", "drugauthorizationnumb": "076704", "drugbatchnumb": null, "drugstructuredosagenumb": 47.5, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "FURTHER REDUCTION TO 95 MG/D (1/2-0-1/2) FROM GW 32 UNTIL DELIVERY", "drugdosageform": null, "drugadministrationroute": "064", "drugindication": null, "drugstartdateformat": "610", "drugstartdate": "2024-07-01T00:00:00", "drugenddateformat": "610", "drugenddate": "2024-08-01T00:00:00", "drugtreatmentduration": 29.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "METOPROLOL" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "METOPROLOL", "drugauthorizationnumb": "076704", "drugbatchnumb": null, "drugstructuredosagenumb": 47.5, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "FURTHER REDUCTION TO 95 MG/D (1/2-0-1/2) FROM GW 32 UNTIL DELIVERY", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": "610", "drugstartdate": "2024-07-01T00:00:00", "drugenddateformat": "610", "drugenddate": "2024-08-01T00:00:00", "drugtreatmentduration": 29.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "METOPROLOL" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "METOPROLOL", "drugauthorizationnumb": "076704", "drugbatchnumb": null, "drugstructuredosagenumb": 47.5, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "FURTHER REDUCTION TO 95 MG/D (1/2-0-1/2) FROM GW 32 UNTIL DELIVERY", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": "610", "drugstartdate": "2024-07-01T00:00:00", "drugenddateformat": "610", "drugenddate": "2024-08-01T00:00:00", "drugtreatmentduration": 29.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "METOPROLOL" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "METOPROLOL", "drugauthorizationnumb": "076704", "drugbatchnumb": null, "drugstructuredosagenumb": 47.5, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "FURTHER REDUCTION TO 95 MG/D (1/2-0-1/2) FROM GW 32 UNTIL DELIVERY", "drugdosageform": null, "drugadministrationroute": "064", "drugindication": null, "drugstartdateformat": "610", "drugstartdate": "2024-07-01T00:00:00", "drugenddateformat": "610", "drugenddate": "2024-08-01T00:00:00", "drugtreatmentduration": 29.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "METOPROLOL" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "METOPROLOL", "drugauthorizationnumb": "076704", "drugbatchnumb": null, "drugstructuredosagenumb": 47.5, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "FURTHER REDUCTION TO 95 MG/D (1/2-0-1/2) FROM GW 32 UNTIL DELIVERY", "drugdosageform": null, "drugadministrationroute": "064", "drugindication": null, "drugstartdateformat": "610", "drugstartdate": "2024-07-01T00:00:00", "drugenddateformat": "610", "drugenddate": "2024-08-01T00:00:00", "drugtreatmentduration": 29.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "METOPROLOL" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "DUPIXENT", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 300.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 2.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNTIL APPROXIMATELY GW 11", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Neurodermatitis", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": 5.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "DUPILUMAB" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "DUPIXENT", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 300.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 2.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNTIL APPROXIMATELY GW 11", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": 5.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "DUPILUMAB" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "DUPIXENT", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 300.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 2.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNTIL APPROXIMATELY GW 11", "drugdosageform": null, "drugadministrationroute": "064", "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": 5.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "DUPILUMAB" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "DUPIXENT", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 300.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 2.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNTIL APPROXIMATELY GW 11", "drugdosageform": null, "drugadministrationroute": "064", "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": 5.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "DUPILUMAB" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "DUPIXENT", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 300.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 2.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNTIL APPROXIMATELY GW 11", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": 5.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "DUPILUMAB" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "DUPIXENT", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 300.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 2.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNTIL APPROXIMATELY GW 11", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": 5.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "DUPILUMAB" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "DUPIXENT", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 300.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 2.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNTIL APPROXIMATELY GW 11", "drugdosageform": null, "drugadministrationroute": "064", "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": 5.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "DUPILUMAB" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "DUPIXENT", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 300.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 2.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNTIL APPROXIMATELY GW 11", "drugdosageform": null, "drugadministrationroute": "064", "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": 5.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "DUPILUMAB" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "BOOSTRIX", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Immunisation", "drugstartdateformat": "610", "drugstartdate": "2024-07-01T00:00:00", "drugenddateformat": "610", "drugenddate": "2024-07-01T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "TETANUS TOXOID, REDUCED DIPHTHERIA TOXOID AND ACELLULAR PERTUSSIS VACCINE ADSORBED, TDAP" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "BOOSTRIX", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": "610", "drugstartdate": "2024-07-01T00:00:00", "drugenddateformat": "610", "drugenddate": "2024-07-01T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "TETANUS TOXOID, REDUCED DIPHTHERIA TOXOID AND ACELLULAR PERTUSSIS VACCINE ADSORBED, TDAP" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "BOOSTRIX", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": null, "drugadministrationroute": "064", "drugindication": null, "drugstartdateformat": "610", "drugstartdate": "2024-07-01T00:00:00", "drugenddateformat": "610", "drugenddate": "2024-07-01T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "TETANUS TOXOID, REDUCED DIPHTHERIA TOXOID AND ACELLULAR PERTUSSIS VACCINE ADSORBED, TDAP" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "BOOSTRIX", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": null, "drugadministrationroute": "064", "drugindication": null, "drugstartdateformat": "610", "drugstartdate": "2024-07-01T00:00:00", "drugenddateformat": "610", "drugenddate": "2024-07-01T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "TETANUS TOXOID, REDUCED DIPHTHERIA TOXOID AND ACELLULAR PERTUSSIS VACCINE ADSORBED, TDAP" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "BOOSTRIX", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": "610", "drugstartdate": "2024-07-01T00:00:00", "drugenddateformat": "610", "drugenddate": "2024-07-01T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "TETANUS TOXOID, REDUCED DIPHTHERIA TOXOID AND ACELLULAR PERTUSSIS VACCINE ADSORBED, TDAP" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "BOOSTRIX", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": "610", "drugstartdate": "2024-07-01T00:00:00", "drugenddateformat": "610", "drugenddate": "2024-07-01T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "TETANUS TOXOID, REDUCED DIPHTHERIA TOXOID AND ACELLULAR PERTUSSIS VACCINE ADSORBED, TDAP" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "BOOSTRIX", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": null, "drugadministrationroute": "064", "drugindication": null, "drugstartdateformat": "610", "drugstartdate": "2024-07-01T00:00:00", "drugenddateformat": "610", "drugenddate": "2024-07-01T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "TETANUS TOXOID, REDUCED DIPHTHERIA TOXOID AND ACELLULAR PERTUSSIS VACCINE ADSORBED, TDAP" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "BOOSTRIX", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": null, "drugadministrationroute": "064", "drugindication": null, "drugstartdateformat": "610", "drugstartdate": "2024-07-01T00:00:00", "drugenddateformat": "610", "drugenddate": "2024-07-01T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "TETANUS TOXOID, REDUCED DIPHTHERIA TOXOID AND ACELLULAR PERTUSSIS VACCINE ADSORBED, TDAP" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20240801" }, "primarysource": { "reportercountry": "EU", "qualification": 1, "literaturereference": null }, "primarysourcecountry": "EU", "quarter": "2025Q4", "receiptdate": "2025-10-28T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-28T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "BFARM", "duplicatenumb": "EU-BFARM-25007289" } ], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "MYLAN" }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 1, "seriousnesslifethreatening": 2, "seriousnessother": 1, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-17T00:00:00", "transmissiondateformat": "102" }
25971166 Type 1
Non-Serious
JAKAFI
Report Version
1
Receive Date
10/28/2025
Receipt Date
10/28/2025
Transmission Date
01/17/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Consumer
Literature Reference
--
Company Number
US-EVENT-004702
Authority Number
--
Sender Organization
INCYTE
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
No
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
--
Patient Age Group
--
Patient Sex
--
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Therapeutic response unexpected (v28.1) Unknown

Drugs (1)

JAKAFI (RUXOLITINIB) Suspect
Route: 065 | Dosage: UNK | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: 202192 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Unknown
Recurrences: --

Clinical Narrative

--

Report Duplicates (1)

EVENT: US-EVENT-004702

Raw JSON (click to expand)

{ "_id": "69974fbd8e900fe3f48c5e92", "safetyreportid": "25971166", "authoritynumb": null, "companynumb": "US-EVENT-004702", "duplicate": 1, "fulfillexpeditecriteria": 2, "occurcountry": "US", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": null, "patientsex": null, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Therapeutic response unexpected", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "JAKAFI", "drugauthorizationnumb": "202192", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "RUXOLITINIB" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "US", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-28T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-28T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "EVENT", "duplicatenumb": "US-EVENT-004702" } ], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "INCYTE" }, "serious": 2, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-17T00:00:00", "transmissiondateformat": "102" }
25971163 Type 1
Serious
WEGOVY, MVITE, ATORVASTATIN (+5 more)
Report Version
1
Receive Date
10/28/2025
Receipt Date
10/28/2025
Transmission Date
01/18/2026
Primary Source Country
NZ
Occurrence Country
NZ
Reporter Country
NZ
Reporter Qualification
Other Health Professional
Literature Reference
--
Company Number
NZ-NOVOPROD-1544377
Authority Number
--
Sender Organization
NOVO NORDISK
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
59.0 yr
Patient Age Group
--
Patient Sex
Female
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (11)

Acute psychosis (v28.1) Recovering
Abnormal behaviour (v28.1) Recovering
Emotional disorder (v28.1) Recovering
Flight of ideas (v28.1) Recovering
Logorrhoea (v28.1) Recovering
Loose associations (v28.1) Recovering
Mental impairment (v28.1) Recovering
Paranoia (v28.1) Recovering
Poor quality sleep (v28.1) Recovering
Therapy change (v28.1) Recovering
Product use issue (v28.1) Unknown

Drugs (8)

WEGOVY (SEMAGLUTIDE) Suspect
Route: -- | Dosage: 0.5 MG, QW | Form: Solution for injection | Indication: Weight control | Action: Withdrawn
Auth#: 215256 | Batch#: -- | Structured Dosage: 0.5 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 wk | Cumulative: -- (unit: --)
Start: 09/10/2025 | End: 09/16/2025 | Duration: 6.0 day | Rechallenge: -- | Additional: Yes
Recurrences: --
MVITE (--) Concomitant
Route: -- | Dosage: UNK | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: unknown | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
ATORVASTATIN (ATORVASTATIN) Concomitant
Route: -- | Dosage: 20 MG, QD | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: unknown | Structured Dosage: 20.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
CELECOXIB (CELECOXIB) Concomitant
Route: -- | Dosage: UNK | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: unknown | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
ESTRIOL (ESTRIOL) Concomitant
Route: -- | Dosage: UNK | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: unknown | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
OMEPRAZOLE (OMEPRAZOLE) Concomitant
Route: -- | Dosage: 10 MG, QD | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: unknown | Structured Dosage: 10.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
OXYBUTYNIN (OXYBUTYNIN) Concomitant
Route: -- | Dosage: 5 MG, QD | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: unknown | Structured Dosage: 5.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
ACETAMINOPHEN (ACETAMINOPHEN) Concomitant
Route: -- | Dosage: 1000 MG, QID | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: unknown | Structured Dosage: 1000.0 (unit: 003) | Separate Dosage#: 4.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250901

Report Duplicates (1)

MEDSAFE: NZ-MEDSAFE-164142

Raw JSON (click to expand)

{ "_id": "69974fbb8e900fe3f48c5e8d", "safetyreportid": "25971163", "authoritynumb": null, "companynumb": "NZ-NOVOPROD-1544377", "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "NZ", "patient": { "patientonsetage": 59.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Acute psychosis", "reactionoutcome": 2 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Abnormal behaviour", "reactionoutcome": 2 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Emotional disorder", "reactionoutcome": 2 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Flight of ideas", "reactionoutcome": 2 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Logorrhoea", "reactionoutcome": 2 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Loose associations", "reactionoutcome": 2 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Mental impairment", "reactionoutcome": 2 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Paranoia", "reactionoutcome": 2 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Poor quality sleep", "reactionoutcome": 2 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Therapy change", "reactionoutcome": 2 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Product use issue", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "WEGOVY", "drugauthorizationnumb": "215256", "drugbatchnumb": null, "drugstructuredosagenumb": 0.5, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "0.5 MG, QW", "drugdosageform": "Solution for injection", "drugadministrationroute": null, "drugindication": "Weight control", "drugstartdateformat": "102", "drugstartdate": "2025-09-10T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-09-16T00:00:00", "drugtreatmentduration": 6.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "SEMAGLUTIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "MVITE", "drugauthorizationnumb": null, "drugbatchnumb": "unknown", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": null, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "ATORVASTATIN", "drugauthorizationnumb": null, "drugbatchnumb": "unknown", "drugstructuredosagenumb": 20.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "20 MG, QD", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "ATORVASTATIN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "CELECOXIB", "drugauthorizationnumb": null, "drugbatchnumb": "unknown", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "CELECOXIB" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "ESTRIOL", "drugauthorizationnumb": null, "drugbatchnumb": "unknown", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "ESTRIOL" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "OMEPRAZOLE", "drugauthorizationnumb": null, "drugbatchnumb": "unknown", "drugstructuredosagenumb": 10.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "10 MG, QD", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "OMEPRAZOLE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "OXYBUTYNIN", "drugauthorizationnumb": null, "drugbatchnumb": "unknown", "drugstructuredosagenumb": 5.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "5 MG, QD", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "OXYBUTYNIN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "ACETAMINOPHEN", "drugauthorizationnumb": null, "drugbatchnumb": "unknown", "drugstructuredosagenumb": 1000.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 4.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "1000 MG, QID", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "ACETAMINOPHEN" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250901" }, "primarysource": { "reportercountry": "NZ", "qualification": 3, "literaturereference": null }, "primarysourcecountry": "NZ", "quarter": "2025Q4", "receiptdate": "2025-10-28T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-28T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "MEDSAFE", "duplicatenumb": "NZ-MEDSAFE-164142" } ], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "NOVO NORDISK" }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 1, "seriousnesslifethreatening": 2, "seriousnessother": 1, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-18T00:00:00", "transmissiondateformat": "102" }
25971161 Type 1
Serious
ALBUTEROL SULFATE, ADVAIR HFA, ADVAIR HFA (+6 more)
Report Version
1
Receive Date
10/28/2025
Receipt Date
10/28/2025
Transmission Date
01/17/2026
Primary Source Country
CA
Occurrence Country
CA
Reporter Country
CA
Reporter Qualification
Physician
Literature Reference
--
Company Number
CA-BAUSCH-BH-2025-019150
Authority Number
--
Sender Organization
BAUSCH AND LOMB
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
68.0 yr
Patient Age Group
Elderly
Patient Sex
Male
Patient Weight
77.0 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (19)

Asthma (v28.1) Unknown
Cardiac dysfunction (v28.1) Unknown
Chronic obstructive pulmonary disease (v28.1) Unknown
Dyspnoea (v28.1) Unknown
Expiratory reserve volume decreased (v28.1) Unknown
Fatigue (v28.1) Unknown
Full blood count abnormal (v28.1) Unknown
Increased viscosity of bronchial secretion (v28.1) Unknown
Left ventricular dysfunction (v28.1) Unknown
Loss of personal independence in daily activities (v28.1) Unknown
Lung disorder (v28.1) Unknown
Muscular weakness (v28.1) Unknown
Myopathy (v28.1) Unknown
Obstructive airways disorder (v28.1) Unknown
Oxygen saturation abnormal (v28.1) Unknown
Wheezing (v28.1) Unknown
Eosinophilic bronchitis (v28.1) Unknown
Diastolic hypertension (v28.1) Unknown
Therapeutic product effect incomplete (v28.1) Unknown

Drugs (9)

ALBUTEROL SULFATE (ALBUTEROL SULFATE) Suspect
Route: 065 | Dosage: NOT SPECIFIED | Form: -- | Indication: Asthma | Action: Unknown
Auth#: 75358 | Batch#: Unknown | Structured Dosage: 400.0 (unit: 004) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
ADVAIR HFA (FLUTICASONE PROPIONATE\SALMETEROL XINAFOATE) Suspect
Route: -- | Dosage: NOT SPECIFIED (2 ADMINISTRATIONS) | Form: -- | Indication: Asthma | Action: Unknown
Auth#: -- | Batch#: Unknown | Structured Dosage: 2.0 (unit: 032) | Separate Dosage#: 1.0 | Interval: 12.0 hr | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
ADVAIR HFA (FLUTICASONE PROPIONATE\SALMETEROL XINAFOATE) Suspect
Route: -- | Dosage: NOT SPECIFIED | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: Unknown | Structured Dosage: 500.0 (unit: 004) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
CANDESARTAN (CANDESARTAN) Suspect
Route: 048 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: Unknown | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
FLOVENT DISKUS (FLUTICASONE PROPIONATE) Suspect
Route: 065 | Dosage: FLOVENT DISKUS (2 ADMINISTRATIONS) | Form: Powder | Indication: Asthma | Action: Unknown
Auth#: -- | Batch#: Unknown | Structured Dosage: 4.0 (unit: 032) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
FLOVENT DISKUS (FLUTICASONE PROPIONATE) Suspect
Route: 065 | Dosage: -- | Form: Powder | Indication: -- | Action: Unknown
Auth#: -- | Batch#: Unknown | Structured Dosage: 500.0 (unit: 004) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
PREDNISONE (PREDNISONE) Suspect
Route: 065 | Dosage: NOT SPECIFIED | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: Unknown | Structured Dosage: 7.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
TIOTROPIUM BROMIDE MONOHYDRATE (TIOTROPIUM BROMIDE MONOHYDRATE) Suspect
Route: 065 | Dosage: NOT SPECIFIED | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: Unknown | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
WIXELA INHUB (FLUTICASONE PROPIONATE\SALMETEROL XINAFOATE) Suspect
Route: -- | Dosage: -- | Form: Inhalation powder | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: Unknown | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --

Clinical Narrative

--

Report Duplicates (1)

Adverse Reaction Report Number: 001155330

Raw JSON (click to expand)

{ "_id": "69974fbb8e900fe3f48c5e8c", "safetyreportid": "25971161", "authoritynumb": null, "companynumb": "CA-BAUSCH-BH-2025-019150", "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "CA", "patient": { "patientonsetage": 68.0, "patientonsetageunit": 801, "patientagegroup": 6, "patientweight": 77.0, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Asthma", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Cardiac dysfunction", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Chronic obstructive pulmonary disease", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Dyspnoea", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Expiratory reserve volume decreased", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Fatigue", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Full blood count abnormal", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Increased viscosity of bronchial secretion", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Left ventricular dysfunction", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Loss of personal independence in daily activities", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Lung disorder", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Muscular weakness", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Myopathy", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Obstructive airways disorder", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Oxygen saturation abnormal", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Wheezing", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Eosinophilic bronchitis", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Diastolic hypertension", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Therapeutic product effect incomplete", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "ALBUTEROL SULFATE", "drugauthorizationnumb": "75358", "drugbatchnumb": "Unknown", "drugstructuredosagenumb": 400.0, "drugstructuredosageunit": "004", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "NOT SPECIFIED", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": "Asthma", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "ALBUTEROL SULFATE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "ADVAIR HFA", "drugauthorizationnumb": null, "drugbatchnumb": "Unknown", "drugstructuredosagenumb": 2.0, "drugstructuredosageunit": "032", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 12.0, "drugintervaldosagedefinition": 805, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "NOT SPECIFIED (2 ADMINISTRATIONS)", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Asthma", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "FLUTICASONE PROPIONATE\\SALMETEROL XINAFOATE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "ADVAIR HFA", "drugauthorizationnumb": null, "drugbatchnumb": "Unknown", "drugstructuredosagenumb": 500.0, "drugstructuredosageunit": "004", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "NOT SPECIFIED", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "FLUTICASONE PROPIONATE\\SALMETEROL XINAFOATE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "CANDESARTAN", "drugauthorizationnumb": null, "drugbatchnumb": "Unknown", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": "048", "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "CANDESARTAN" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "FLOVENT DISKUS", "drugauthorizationnumb": null, "drugbatchnumb": "Unknown", "drugstructuredosagenumb": 4.0, "drugstructuredosageunit": "032", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "FLOVENT DISKUS (2 ADMINISTRATIONS)", "drugdosageform": "Powder", "drugadministrationroute": "065", "drugindication": "Asthma", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "FLUTICASONE PROPIONATE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "FLOVENT DISKUS", "drugauthorizationnumb": null, "drugbatchnumb": "Unknown", "drugstructuredosagenumb": 500.0, "drugstructuredosageunit": "004", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Powder", "drugadministrationroute": "065", "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "FLUTICASONE PROPIONATE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "PREDNISONE", "drugauthorizationnumb": null, "drugbatchnumb": "Unknown", "drugstructuredosagenumb": 7.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "NOT SPECIFIED", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "PREDNISONE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "TIOTROPIUM BROMIDE MONOHYDRATE", "drugauthorizationnumb": null, "drugbatchnumb": "Unknown", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "NOT SPECIFIED", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "TIOTROPIUM BROMIDE MONOHYDRATE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "WIXELA INHUB", "drugauthorizationnumb": null, "drugbatchnumb": "Unknown", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Inhalation powder", "drugadministrationroute": null, "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "FLUTICASONE PROPIONATE\\SALMETEROL XINAFOATE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "CA", "qualification": 1, "literaturereference": null }, "primarysourcecountry": "CA", "quarter": "2025Q4", "receiptdate": "2025-10-28T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-28T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "Adverse Reaction Report Number", "duplicatenumb": "001155330" } ], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "BAUSCH AND LOMB" }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 1, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-17T00:00:00", "transmissiondateformat": "102" }