FDA FAERS Adverse Event Reports

111000
Total Reports
60668
Serious Reports
108
Reporter Countries
Clear
25960994 Type 1
Serious
ELTROMBOPAG OLAMINE
Report Version
1
Receive Date
10/27/2025
Receipt Date
10/27/2025
Transmission Date
01/17/2026
Primary Source Country
TN
Occurrence Country
TN
Reporter Country
TN
Reporter Qualification
Physician
Literature Reference
--
Company Number
TN-002147023-NVSC2025TN164995
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
25.0 yr
Patient Age Group
--
Patient Sex
Female
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Death (v28.1) Fatal
Product availability issue (v28.1) Fatal

Drugs (1)

ELTROMBOPAG OLAMINE (ELTROMBOPAG OLAMINE) Suspect
Route: 065 | Dosage: UNK | Form: -- | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: 22291 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20251009

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435b13b3830196fa576d3", "safetyreportid": "25960994", "authoritynumb": null, "companynumb": "TN-002147023-NVSC2025TN164995", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "TN", "patient": { "patientonsetage": 25.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Death", "reactionoutcome": 5 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Product availability issue", "reactionoutcome": 5 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "ELTROMBOPAG OLAMINE", "drugauthorizationnumb": "22291", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "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": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "ELTROMBOPAG OLAMINE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20251009" }, "primarysource": { "reportercountry": "TN", "qualification": 1, "literaturereference": null }, "primarysourcecountry": "TN", "quarter": "2025Q4", "receiptdate": "2025-10-27T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-27T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "NOVARTIS" }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 1, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 1, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-17T00:00:00", "transmissiondateformat": "102" }
25960999 Type 1
Non-Serious
XOLAIR
Report Version
1
Receive Date
10/27/2025
Receipt Date
10/27/2025
Transmission Date
01/17/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Consumer
Literature Reference
--
Company Number
US-ROCHE-10000414646
Authority Number
--
Sender Organization
ROCHE
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
Adult
Patient Sex
Male
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Urticaria (v28.1) Unknown

Drugs (1)

XOLAIR (OMALIZUMAB) Suspect
Route: 058 | Dosage: STRENGTH: 300 MG/2ML | Form: Solution for injection in pre-filled syringe | Indication: Urticaria | Action: Dose Not Changed
Auth#: -- | Batch#: Unknown | Structured Dosage: 300.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 30.0 day | Cumulative: -- (unit: --)
Start: 06/01/2025 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435b13b3830196fa576d7", "safetyreportid": "25960999", "authoritynumb": null, "companynumb": "US-ROCHE-10000414646", "duplicate": null, "fulfillexpeditecriteria": 2, "occurcountry": "US", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": 5, "patientweight": null, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Urticaria", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "XOLAIR", "drugauthorizationnumb": null, "drugbatchnumb": "Unknown", "drugstructuredosagenumb": 300.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 30.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "STRENGTH: 300 MG/2ML", "drugdosageform": "Solution for injection in pre-filled syringe", "drugadministrationroute": "058", "drugindication": "Urticaria", "drugstartdateformat": "610", "drugstartdate": "2025-06-01T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "OMALIZUMAB" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "US", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-27T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-27T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "ROCHE" }, "serious": 2, "seriousnesscongenitalanomali": null, "seriousnessdeath": null, "seriousnessdisabling": null, "seriousnesshospitalization": null, "seriousnesslifethreatening": null, "seriousnessother": null, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-17T00:00:00", "transmissiondateformat": "102" }
25960997 Type 1
Non-Serious
PLUVICTO
Report Version
1
Receive Date
10/27/2025
Receipt Date
10/27/2025
Transmission Date
01/18/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Other Health Professional
Literature Reference
--
Company Number
US-002147023-NVSC2025US160264
Authority Number
--
Sender Organization
NOVARTIS
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
--
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

General physical health deterioration (v28.1) Unknown

Drugs (1)

PLUVICTO (LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN) Suspect
Route: 065 | Dosage: UNK | Form: Solution for injection/infusion | Indication: Product used for unknown indication | Action: Unknown
Auth#: 215833 | 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": "69d435b13b3830196fa576d5", "safetyreportid": "25960997", "authoritynumb": null, "companynumb": "US-002147023-NVSC2025US160264", "duplicate": null, "fulfillexpeditecriteria": 2, "occurcountry": "US", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": null, "patientsex": null, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "General physical health deterioration", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "PLUVICTO", "drugauthorizationnumb": "215833", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": "Solution for injection/infusion", "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": "LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "US", "qualification": 3, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-27T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-27T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "NOVARTIS" }, "serious": 2, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-18T00:00:00", "transmissiondateformat": "102" }
25960989 Type 2
Serious
SKYRIZI, PREDNISONE
Report Version
1
Receive Date
10/27/2025
Receipt Date
10/27/2025
Transmission Date
01/17/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Consumer
Literature Reference
--
Company Number
US-ABBVIE-6514343
Authority Number
--
Sender Organization
ABBVIE
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
69.0 yr
Patient Age Group
--
Patient Sex
Male
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Hip arthroplasty (v28.1) Recovered

Drugs (2)

SKYRIZI (RISANKIZUMAB-RZAA) Suspect
Route: 058 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: 761105 | Batch#: Not Available | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
PREDNISONE (PREDNISONE) Suspect
Route: 065 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250401

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435b13b3830196fa576aa", "safetyreportid": "25960989", "authoritynumb": null, "companynumb": "US-ABBVIE-6514343", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "US", "patient": { "patientonsetage": 69.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": null, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Hip arthroplasty", "reactionoutcome": 1 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "SKYRIZI", "drugauthorizationnumb": "761105", "drugbatchnumb": "Not Available", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": "058", "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": "RISANKIZUMAB-RZAA" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "PREDNISONE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "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": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250401" }, "primarysource": { "reportercountry": "US", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-27T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-27T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 2, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "ABBVIE" }, "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" }
25960991 Type 1
Non-Serious
ALBUTEROL
Report Version
1
Receive Date
10/27/2025
Receipt Date
10/27/2025
Transmission Date
01/18/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Consumer
Literature Reference
--
Company Number
US-CIPLA LTD.-2025US12984
Authority Number
--
Sender Organization
CIPLA
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
5
Duplicate
--
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 (2)

Drug dose omission by device (v28.1) Unknown
Device delivery system issue (v28.1) Unknown

Drugs (1)

ALBUTEROL (ALBUTEROL) Suspect
Route: 065 | Dosage: 90 MICROGRAM, PRN (1 PUFF EVERY 6 HOURS AS NEEDED) | Form: AEROSOL | Indication: Product used for unknown indication | Action: Dose Not Changed
Auth#: 209959 | Batch#: 5IB0355 | Structured Dosage: 90.0 (unit: 004) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435b13b3830196fa576a6", "safetyreportid": "25960991", "authoritynumb": null, "companynumb": "US-CIPLA LTD.-2025US12984", "duplicate": null, "fulfillexpeditecriteria": 5, "occurcountry": "US", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": null, "patientsex": null, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Drug dose omission by device", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Device delivery system issue", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "ALBUTEROL", "drugauthorizationnumb": "209959", "drugbatchnumb": "5IB0355", "drugstructuredosagenumb": 90.0, "drugstructuredosageunit": "004", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "90 MICROGRAM, PRN (1 PUFF EVERY 6 HOURS AS NEEDED)", "drugdosageform": "AEROSOL", "drugadministrationroute": "065", "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "ALBUTEROL" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "US", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-27T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-27T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "CIPLA" }, "serious": 2, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-18T00:00:00", "transmissiondateformat": "102" }
25960990 Type 1
Non-Serious
INVEGA TRINZA, INVEGA TRINZA, INVEGA TRINZA
Report Version
1
Receive Date
10/27/2025
Receipt Date
10/27/2025
Transmission Date
01/17/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Consumer
Literature Reference
--
Company Number
US-JNJFOC-20251007327
Authority Number
--
Sender Organization
JOHNSON AND JOHNSON
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
Male
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Product dose omission issue (v28.1) Unknown
Off label use (v28.1) Unknown

Drugs (3)

INVEGA TRINZA (PALIPERIDONE PALMITATE) Suspect
Route: 065 | Dosage: -- | Form: Suspension for injection | Indication: Product used for unknown indication | Action: Unknown
Auth#: 207946 | Batch#: Unknown | Structured Dosage: 410.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
INVEGA TRINZA (PALIPERIDONE PALMITATE) Suspect
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: Unknown
Auth#: 207946 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
INVEGA TRINZA (PALIPERIDONE PALMITATE) Suspect
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: Unknown
Auth#: 207946 | 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": "69d435b13b3830196fa5769e", "safetyreportid": "25960990", "authoritynumb": null, "companynumb": "US-JNJFOC-20251007327", "duplicate": null, "fulfillexpeditecriteria": 2, "occurcountry": "US", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": null, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Product dose omission issue", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Off label use", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "INVEGA TRINZA", "drugauthorizationnumb": "207946", "drugbatchnumb": "Unknown", "drugstructuredosagenumb": 410.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Suspension for injection", "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": "PALIPERIDONE PALMITATE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "INVEGA TRINZA", "drugauthorizationnumb": "207946", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "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": "PALIPERIDONE PALMITATE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "INVEGA TRINZA", "drugauthorizationnumb": "207946", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "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": "PALIPERIDONE PALMITATE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "US", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-27T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-27T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "JOHNSON AND JOHNSON" }, "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" }
25960982 Type 1
Serious
ALPRAZOLAM
Report Version
1
Receive Date
10/27/2025
Receipt Date
10/27/2025
Transmission Date
01/18/2026
Primary Source Country
EU
Occurrence Country
EU
Reporter Country
EU
Reporter Qualification
Physician
Literature Reference
--
Company Number
--
Authority Number
EU-AFSSAPS-GR2025001514
Sender Organization
TEVA
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
17.0 yr
Patient Age Group
--
Patient Sex
Female
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Poisoning deliberate (v28.1) Recovered
Somnolence (v28.1) Recovered

Drugs (1)

ALPRAZOLAM (ALPRAZOLAM) Suspect
Route: 048 | Dosage: TIME INTERVAL: TOTAL: 0.25 MG X30CP | Form: -- | Indication: Poisoning deliberate | Action: Withdrawn
Auth#: 074342 | Batch#: UNKNOWN | Structured Dosage: 30.0 (unit: 032) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: 30.0 (unit: 032)
Start: 09/02/2025 | End: 09/02/2025 | Duration: 1.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250902

Report Duplicates (2)

AFSSAPS: EU-AFSSAPS-2025089436
AFSSAPS: EU-AFSSAPS-GR2025001514

Raw JSON (click to expand)

{ "_id": "69d435b13b3830196fa57696", "safetyreportid": "25960982", "authoritynumb": "EU-AFSSAPS-GR2025001514", "companynumb": null, "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "EU", "patient": { "patientonsetage": 17.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Poisoning deliberate", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Somnolence", "reactionoutcome": 1 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "ALPRAZOLAM", "drugauthorizationnumb": "074342", "drugbatchnumb": "UNKNOWN", "drugstructuredosagenumb": 30.0, "drugstructuredosageunit": "032", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": 30.0, "drugcumulativedosageunit": "032", "drugdosagetext": "TIME INTERVAL: TOTAL: 0.25 MG X30CP", "drugdosageform": null, "drugadministrationroute": "048", "drugindication": "Poisoning deliberate", "drugstartdateformat": "102", "drugstartdate": "2025-09-02T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-09-02T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "ALPRAZOLAM" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250902" }, "primarysource": { "reportercountry": "EU", "qualification": 1, "literaturereference": null }, "primarysourcecountry": "EU", "quarter": "2025Q4", "receiptdate": "2025-10-27T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-27T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "AFSSAPS", "duplicatenumb": "EU-AFSSAPS-2025089436" }, { "duplicatesource": "AFSSAPS", "duplicatenumb": "EU-AFSSAPS-GR2025001514" } ], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "TEVA" }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 1, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-18T00:00:00", "transmissiondateformat": "102" }
25960986 Type 1
Non-Serious
TREMFYA
Report Version
1
Receive Date
10/27/2025
Receipt Date
10/27/2025
Transmission Date
01/17/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Other Health Professional
Literature Reference
--
Company Number
US-JNJFOC-20251027393
Authority Number
--
Sender Organization
JOHNSON AND JOHNSON
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
--
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (3)

Cough (v28.1) Unknown
Respiration abnormal (v28.1) Unknown
Injection site reaction (v28.1) Unknown

Drugs (1)

TREMFYA (GUSELKUMAB) Suspect
Route: 065 | Dosage: -- | Form: Solution for injection in pre-filled pen | Indication: Product used for unknown indication | Action: Unknown
Auth#: 761061 | Batch#: Unknown | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Unknown
Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435b13b3830196fa57691", "safetyreportid": "25960986", "authoritynumb": null, "companynumb": "US-JNJFOC-20251027393", "duplicate": null, "fulfillexpeditecriteria": 2, "occurcountry": "US", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": null, "patientsex": null, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Cough", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Respiration abnormal", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Injection site reaction", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "TREMFYA", "drugauthorizationnumb": "761061", "drugbatchnumb": "Unknown", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Solution for injection in pre-filled pen", "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": "GUSELKUMAB" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "US", "qualification": 3, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-27T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-27T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "JOHNSON AND JOHNSON" }, "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" }
25960987 Type 1
Non-Serious
RILPIVIRINE, CABOTEGRAVIR
Report Version
1
Receive Date
10/27/2025
Receipt Date
10/27/2025
Transmission Date
01/18/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Physician
Literature Reference
--
Company Number
US-VIIV HEALTHCARE-US2025AMR132269
Authority Number
--
Sender Organization
JOHNSON AND JOHNSON
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
Male
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Viral load increased (v28.1) Unknown
Inappropriate schedule of product administration (v28.1) Unknown

Drugs (2)

RILPIVIRINE (RILPIVIRINE) Suspect
Route: 065 | Dosage: UNK | Form: Prolonged-release suspension for injection | Indication: Product used for unknown indication | Action: Withdrawn
Auth#: -- | Batch#: Unknown | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: --
Recurrences: --
CABOTEGRAVIR (CABOTEGRAVIR) Suspect
Route: 065 | Dosage: UNK | Form: Suspension for injection | Indication: Product used for unknown indication | Action: Withdrawn
Auth#: -- | Batch#: Unknown | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435b13b3830196fa57692", "safetyreportid": "25960987", "authoritynumb": null, "companynumb": "US-VIIV HEALTHCARE-US2025AMR132269", "duplicate": null, "fulfillexpeditecriteria": 2, "occurcountry": "US", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": null, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Viral load increased", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Inappropriate schedule of product administration", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "RILPIVIRINE", "drugauthorizationnumb": null, "drugbatchnumb": "Unknown", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": "Prolonged-release suspension for injection", "drugadministrationroute": "065", "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": null, "actiondrug": 1, "activesubstance": { "activesubstancename": "RILPIVIRINE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "CABOTEGRAVIR", "drugauthorizationnumb": null, "drugbatchnumb": "Unknown", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": "Suspension for injection", "drugadministrationroute": "065", "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 1, "activesubstance": { "activesubstancename": "CABOTEGRAVIR" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "US", "qualification": 1, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-27T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-27T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "JOHNSON AND JOHNSON" }, "serious": 2, "seriousnesscongenitalanomali": null, "seriousnessdeath": null, "seriousnessdisabling": null, "seriousnesshospitalization": null, "seriousnesslifethreatening": null, "seriousnessother": null, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-18T00:00:00", "transmissiondateformat": "102" }
25960977 Type 1
Serious
BESREMI, BESREMI, BESREMI (+32 more)
Report Version
1
Receive Date
10/27/2025
Receipt Date
10/27/2025
Transmission Date
01/18/2026
Primary Source Country
TW
Occurrence Country
TW
Reporter Country
TW
Reporter Qualification
Consumer
Literature Reference
--
Company Number
TW-PHARMAESSENTIA CORPORATION-TW-2025-PEC-008462
Authority Number
--
Sender Organization
PHARMAESSENTIA
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
--
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 (9)

Clostridium difficile colitis (v28.1) Not Recovered
Haemoglobin decreased (v28.1) Not Recovered
Oxygen saturation decreased (v28.1) Not Recovered
Nocturia (v28.1) Not Recovered
Asthenia (v28.1) Not Recovered
Dyspnoea (v28.1) Not Recovered
Decreased appetite (v28.1) Not Recovered
Pyrexia (v28.1) Unknown
Dizziness (v28.1) Not Recovered

Drugs (35)

BESREMI (ROPEGINTERFERON ALFA-2B-NJFT) Suspect
Route: 058 | Dosage: 250 MCG, Q2W | Form: Pre-filled syringe | Indication: Myelofibrosis | Action: Not Applicable
Auth#: 761166 | Batch#: 24DPL-B009H | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: 2.0 wk | Cumulative: -- (unit: --)
Start: 03/14/2025 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
BESREMI (ROPEGINTERFERON ALFA-2B-NJFT) Suspect
Route: 058 | Dosage: 250 MCG, Q2W | Form: Pre-filled syringe | Indication: -- | Action: Not Applicable
Auth#: 761166 | Batch#: 22DPL-B020D | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: 2.0 wk | Cumulative: -- (unit: --)
Start: 03/28/2025 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
BESREMI (ROPEGINTERFERON ALFA-2B-NJFT) Suspect
Route: 058 | Dosage: 375 MCG, Q2W | Form: Pre-filled syringe | Indication: -- | Action: Not Applicable
Auth#: 761166 | Batch#: 24DPL-B001B | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: 2.0 wk | Cumulative: -- (unit: --)
Start: 04/11/2025 | End: 04/11/2025 | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
BESREMI (ROPEGINTERFERON ALFA-2B-NJFT) Suspect
Route: 058 | Dosage: 500 MCG, Q2W | Form: Pre-filled syringe | Indication: -- | Action: Not Applicable
Auth#: 761166 | Batch#: 24DPL-B001B | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: 2.0 wk | Cumulative: -- (unit: --)
Start: 04/25/2025 | End: 04/25/2025 | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
BESREMI (ROPEGINTERFERON ALFA-2B-NJFT) Suspect
Route: 058 | Dosage: 375 MCG, Q2W | Form: Pre-filled syringe | Indication: -- | Action: Not Applicable
Auth#: 761166 | Batch#: 24DPL-B001B | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: 2.0 wk | Cumulative: -- (unit: --)
Start: 05/08/2025 | End: 05/08/2025 | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
BESREMI (ROPEGINTERFERON ALFA-2B-NJFT) Suspect
Route: 058 | Dosage: 400 MCG, Q2W | Form: Pre-filled syringe | Indication: -- | Action: Not Applicable
Auth#: 761166 | Batch#: 24DPL-B001B | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: 2.0 wk | Cumulative: -- (unit: --)
Start: 05/23/2025 | End: 05/23/2025 | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
BESREMI (ROPEGINTERFERON ALFA-2B-NJFT) Suspect
Route: 058 | Dosage: 500 MCG, EVERY 3 WEEKS | Form: Pre-filled syringe | Indication: -- | Action: Not Applicable
Auth#: 761166 | Batch#: 24DPL-B001B | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: 3.0 wk | Cumulative: -- (unit: --)
Start: 06/05/2025 | End: 08/15/2025 | Duration: 71.0 day | Rechallenge: -- | Additional: 4
Recurrences: --
BESREMI (ROPEGINTERFERON ALFA-2B-NJFT) Suspect
Route: 058 | Dosage: 500 MCG, EVERY 3 WEEKS | Form: Pre-filled syringe | Indication: -- | Action: Not Applicable
Auth#: 761166 | Batch#: 24DPL-B001H | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: 3.0 wk | Cumulative: -- (unit: --)
Start: 06/27/2025 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
BESREMI (ROPEGINTERFERON ALFA-2B-NJFT) Suspect
Route: 058 | Dosage: 500 MCG, EVERY 3 WEEKS | Form: Pre-filled syringe | Indication: -- | Action: Not Applicable
Auth#: 761166 | Batch#: 24DPL-B009H | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: 3.0 wk | Cumulative: -- (unit: --)
Start: 09/02/2025 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
ASPIRIN (ASPIRIN) Concomitant
Route: 048 | Dosage: 1 DOSAGE FORM, QD | Form: -- | Indication: Thrombosis prophylaxis | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 1.0 (unit: 032) | Separate Dosage#: 1.0 | Interval: 24.0 hr | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
Acetal (--) Concomitant
Route: 048 | Dosage: 500 MG, 1# PO PRN | Form: -- | Indication: Injection related reaction | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
AUGMENTIN (AMOXICILLIN\CLAVULANATE POTASSIUM) Concomitant
Route: 048 | Dosage: 1 GRAM, 1# PO BID | Form: -- | Indication: Cough | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 1.0 (unit: 002) | Separate Dosage#: 1.0 | Interval: 12.0 hr | Cumulative: -- (unit: --)
Start: 05/14/2025 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
AUGMENTIN (AMOXICILLIN\CLAVULANATE POTASSIUM) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Oropharyngeal pain | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
DICLOFENAC (DICLOFENAC) Concomitant
Route: 048 | Dosage: 50 MILLIGRAM, 1# PO TID | Form: -- | Indication: Pyrexia | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 50.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 8.0 hr | Cumulative: 1050.0 (unit: 003)
Start: 08/01/2025 | End: 08/08/2025 | Duration: 7.0 day | Rechallenge: -- | Additional: --
Recurrences: --
DICLOFENAC (DICLOFENAC) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Injection site pain | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: 1050.0 (unit: 003)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
Brown mixture (--) Concomitant
Route: -- | Dosage: 10ML BID+HS | Form: -- | Indication: Antitussive therapy | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 10.0 (unit: 012) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 08/01/2025 | End: 08/08/2025 | Duration: 7.0 day | Rechallenge: -- | Additional: --
Recurrences: --
Brown mixture (--) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Productive cough | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
SULFAMETHOXAZOLE\TRIMETHOPRIM (SULFAMETHOXAZOLE\TRIMETHOPRIM) Concomitant
Route: 048 | Dosage: 2 DOSAGE FORM, BID | Form: -- | Indication: Pneumonia | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 2.0 (unit: 032) | Separate Dosage#: 1.0 | Interval: 12.0 hr | Cumulative: 51.0 (unit: 032)
Start: 08/01/2025 | End: 08/07/2025 | Duration: 6.0 day | Rechallenge: -- | Additional: --
Recurrences: --
SULFAMETHOXAZOLE\TRIMETHOPRIM (SULFAMETHOXAZOLE\TRIMETHOPRIM) Concomitant
Route: 048 | Dosage: 1 DOSAGE FORM, QD | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 1.0 (unit: 032) | Separate Dosage#: 1.0 | Interval: 24.0 hr | Cumulative: 51.0 (unit: 032)
Start: 08/08/2025 | End: 09/06/2025 | Duration: 29.0 day | Rechallenge: -- | Additional: --
Recurrences: --
SULFAMETHOXAZOLE\TRIMETHOPRIM (SULFAMETHOXAZOLE\TRIMETHOPRIM) Concomitant
Route: 048 | Dosage: 1 DOSAGE FORM, QD | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 1.0 (unit: 032) | Separate Dosage#: 1.0 | Interval: 24.0 hr | Cumulative: 51.0 (unit: 032)
Start: 09/06/2025 | End: 09/30/2025 | Duration: 24.0 day | Rechallenge: -- | Additional: --
Recurrences: --
SULFAMETHOXAZOLE\TRIMETHOPRIM (SULFAMETHOXAZOLE\TRIMETHOPRIM) Concomitant
Route: 048 | Dosage: 1 DOSAGE FORM, QD | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 1.0 (unit: 032) | Separate Dosage#: 1.0 | Interval: 24.0 hr | Cumulative: 51.0 (unit: 032)
Start: 09/30/2025 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
Febuton (--) Concomitant
Route: 048 | Dosage: 80 MILLIGRAM, 1# PO QD | Form: -- | Indication: Hyperuricaemia | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 80.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 24.0 hr | Cumulative: 560.0 (unit: 003)
Start: 08/01/2025 | End: 08/08/2025 | Duration: 7.0 day | Rechallenge: -- | Additional: --
Recurrences: --
OLMESARTAN (OLMESARTAN) Concomitant
Route: 048 | Dosage: 20 MILLIGRAM, 1# PO QD | Form: -- | Indication: Hypertension | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 20.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 24.0 hr | Cumulative: 140.0 (unit: 003)
Start: 08/01/2025 | End: 08/08/2025 | Duration: 7.0 day | Rechallenge: -- | Additional: --
Recurrences: --
PREDNISOLONE (PREDNISOLONE) Concomitant
Route: 048 | Dosage: 5 MILLIGRAM, 1# PO BID | Form: -- | Indication: Pneumonia | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 5.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 12.0 hr | Cumulative: 70.0 (unit: 003)
Start: 08/01/2025 | End: 08/08/2025 | Duration: 7.0 day | Rechallenge: -- | Additional: --
Recurrences: --
NEXIUM (ESOMEPRAZOLE MAGNESIUM) Concomitant
Route: 048 | Dosage: 40 MILLIGRAM, 1# PO QDAC | Form: -- | Indication: Gastrointestinal disorder | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 40.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 24.0 hr | Cumulative: 280.0 (unit: 003)
Start: 08/01/2025 | End: 08/08/2025 | Duration: 7.0 day | Rechallenge: -- | Additional: --
Recurrences: --
JARDIANCE (EMPAGLIFLOZIN) Concomitant
Route: 048 | Dosage: 1 DOSAGE FORM, BID | Form: -- | Indication: Diabetes mellitus | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 1.0 (unit: 032) | Separate Dosage#: 1.0 | Interval: 12.0 hr | Cumulative: 14.0 (unit: 032)
Start: 08/01/2025 | End: 08/08/2025 | Duration: 7.0 day | Rechallenge: -- | Additional: --
Recurrences: --
BISOPROLOL (BISOPROLOL) Concomitant
Route: 048 | Dosage: 5 MILLIGRAM, 1# PO QD | Form: -- | Indication: Hypertension | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 5.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 24.0 hr | Cumulative: 35.0 (unit: 003)
Start: 08/01/2025 | End: 08/08/2025 | Duration: 7.0 day | Rechallenge: -- | Additional: --
Recurrences: --
LEVOFLOXACIN (LEVOFLOXACIN) Concomitant
Route: 048 | Dosage: 750 MILLIGRAM, 1# PO QD | Form: -- | Indication: Pneumonia | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 750.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 24.0 hr | Cumulative: 5250.0 (unit: 003)
Start: 08/01/2025 | End: 08/08/2025 | Duration: 7.0 day | Rechallenge: -- | Additional: --
Recurrences: --
Taita no.5 (--) Concomitant
Route: -- | Dosage: 400ML 1BOT 3DAYS | Form: -- | Indication: Decreased appetite | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 08/08/2025 | End: 08/10/2025 | Duration: 2.0 day | Rechallenge: -- | Additional: --
Recurrences: --
Lyo povigent (--) Concomitant
Route: 042 | Dosage: 4ML 1VIAL IV 3DAYS | Form: -- | Indication: Decreased appetite | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 08/08/2025 | End: 08/10/2025 | Duration: 2.0 day | Rechallenge: -- | Additional: --
Recurrences: --
XANAX (ALPRAZOLAM) Concomitant
Route: 048 | Dosage: 0.5 MG, 1# PO HS | Form: -- | Indication: Sleep disorder | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 08/12/2025 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
METOCLOPRAMIDE HYDROCHLORIDE (METOCLOPRAMIDE HYDROCHLORIDE) Concomitant
Route: 048 | Dosage: 3.84 MG, 1# PO TIDAC | Form: -- | Indication: Nausea | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: 8.0 hr | Cumulative: -- (unit: --)
Start: 08/12/2025 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
METOCLOPRAMIDE HYDROCHLORIDE (METOCLOPRAMIDE HYDROCHLORIDE) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Vomiting | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
FEBUXOSTAT (FEBUXOSTAT) Concomitant
Route: 048 | Dosage: 0.5 DOSAGE FORM, QD (80 MG) | Form: -- | Indication: Hyperuricaemia | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 0.5 (unit: 032) | Separate Dosage#: 1.0 | Interval: 24.0 hr | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
EMPAGLIFLOZIN\METFORMIN HYDROCHLORIDE (EMPAGLIFLOZIN\METFORMIN HYDROCHLORIDE) Concomitant
Route: 048 | Dosage: 1 DOSAGE FORM, QD (12.5/850 MG) | Form: -- | Indication: Diabetes mellitus | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 1.0 (unit: 032) | Separate Dosage#: 1.0 | Interval: 24.0 hr | Cumulative: -- (unit: --)
Start: 09/30/2025 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250904

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435b13b3830196fa57690", "safetyreportid": "25960977", "authoritynumb": null, "companynumb": "TW-PHARMAESSENTIA CORPORATION-TW-2025-PEC-008462", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "TW", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": null, "patientsex": null, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Clostridium difficile colitis", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Haemoglobin decreased", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Oxygen saturation decreased", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Nocturia", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Asthenia", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Dyspnoea", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Decreased appetite", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Pyrexia", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Dizziness", "reactionoutcome": 3 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "BESREMI", "drugauthorizationnumb": "761166", "drugbatchnumb": "24DPL-B009H", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 2.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "250 MCG, Q2W", "drugdosageform": "Pre-filled syringe", "drugadministrationroute": "058", "drugindication": "Myelofibrosis", "drugstartdateformat": "102", "drugstartdate": "2025-03-14T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "ROPEGINTERFERON ALFA-2B-NJFT" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "BESREMI", "drugauthorizationnumb": "761166", "drugbatchnumb": "22DPL-B020D", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 2.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "250 MCG, Q2W", "drugdosageform": "Pre-filled syringe", "drugadministrationroute": "058", "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2025-03-28T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "ROPEGINTERFERON ALFA-2B-NJFT" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "BESREMI", "drugauthorizationnumb": "761166", "drugbatchnumb": "24DPL-B001B", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 2.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "375 MCG, Q2W", "drugdosageform": "Pre-filled syringe", "drugadministrationroute": "058", "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2025-04-11T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-04-11T00:00:00", "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "ROPEGINTERFERON ALFA-2B-NJFT" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "BESREMI", "drugauthorizationnumb": "761166", "drugbatchnumb": "24DPL-B001B", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 2.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "500 MCG, Q2W", "drugdosageform": "Pre-filled syringe", "drugadministrationroute": "058", "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2025-04-25T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-04-25T00:00:00", "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "ROPEGINTERFERON ALFA-2B-NJFT" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "BESREMI", "drugauthorizationnumb": "761166", "drugbatchnumb": "24DPL-B001B", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 2.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "375 MCG, Q2W", "drugdosageform": "Pre-filled syringe", "drugadministrationroute": "058", "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2025-05-08T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-05-08T00:00:00", "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "ROPEGINTERFERON ALFA-2B-NJFT" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "BESREMI", "drugauthorizationnumb": "761166", "drugbatchnumb": "24DPL-B001B", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 2.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "400 MCG, Q2W", "drugdosageform": "Pre-filled syringe", "drugadministrationroute": "058", "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2025-05-23T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-05-23T00:00:00", "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "ROPEGINTERFERON ALFA-2B-NJFT" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "BESREMI", "drugauthorizationnumb": "761166", "drugbatchnumb": "24DPL-B001B", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 3.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "500 MCG, EVERY 3 WEEKS", "drugdosageform": "Pre-filled syringe", "drugadministrationroute": "058", "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2025-06-05T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-08-15T00:00:00", "drugtreatmentduration": 71.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "ROPEGINTERFERON ALFA-2B-NJFT" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "BESREMI", "drugauthorizationnumb": "761166", "drugbatchnumb": "24DPL-B001H", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 3.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "500 MCG, EVERY 3 WEEKS", "drugdosageform": "Pre-filled syringe", "drugadministrationroute": "058", "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2025-06-27T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "ROPEGINTERFERON ALFA-2B-NJFT" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "BESREMI", "drugauthorizationnumb": "761166", "drugbatchnumb": "24DPL-B009H", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 3.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "500 MCG, EVERY 3 WEEKS", "drugdosageform": "Pre-filled syringe", "drugadministrationroute": "058", "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2025-09-02T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "ROPEGINTERFERON ALFA-2B-NJFT" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "ASPIRIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 1.0, "drugstructuredosageunit": "032", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 24.0, "drugintervaldosagedefinition": 805, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "1 DOSAGE FORM, QD", "drugdosageform": null, "drugadministrationroute": "048", "drugindication": "Thrombosis prophylaxis", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "ASPIRIN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "Acetal", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "500 MG, 1# PO PRN", "drugdosageform": null, "drugadministrationroute": "048", "drugindication": "Injection related reaction", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": null, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "AUGMENTIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 1.0, "drugstructuredosageunit": "002", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 12.0, "drugintervaldosagedefinition": 805, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "1 GRAM, 1# PO BID", "drugdosageform": null, "drugadministrationroute": "048", "drugindication": "Cough", "drugstartdateformat": "102", "drugstartdate": "2025-05-14T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "AMOXICILLIN\\CLAVULANATE POTASSIUM" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "AUGMENTIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Oropharyngeal pain", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "AMOXICILLIN\\CLAVULANATE POTASSIUM" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "DICLOFENAC", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 50.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 8.0, "drugintervaldosagedefinition": 805, "drugcumulativedosagenumb": 1050.0, "drugcumulativedosageunit": "003", "drugdosagetext": "50 MILLIGRAM, 1# PO TID", "drugdosageform": null, "drugadministrationroute": 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null, "activesubstance": null, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "XANAX", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "0.5 MG, 1# PO HS", "drugdosageform": null, "drugadministrationroute": "048", "drugindication": "Sleep disorder", "drugstartdateformat": "102", "drugstartdate": "2025-08-12T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "ALPRAZOLAM" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "METOCLOPRAMIDE HYDROCHLORIDE", "drugauthorizationnumb": null, 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MG)", "drugdosageform": null, "drugadministrationroute": "048", "drugindication": "Hyperuricaemia", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "FEBUXOSTAT" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "EMPAGLIFLOZIN\\METFORMIN HYDROCHLORIDE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 1.0, "drugstructuredosageunit": "032", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 24.0, "drugintervaldosagedefinition": 805, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "1 DOSAGE FORM, QD (12.5/850 MG)", "drugdosageform": null, "drugadministrationroute": "048", "drugindication": "Diabetes mellitus", "drugstartdateformat": "102", "drugstartdate": "2025-09-30T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "EMPAGLIFLOZIN\\METFORMIN HYDROCHLORIDE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250904" }, "primarysource": { "reportercountry": "TW", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "TW", "quarter": "2025Q4", "receiptdate": "2025-10-27T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-27T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "PHARMAESSENTIA" }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 1, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-18T00:00:00", "transmissiondateformat": "102" }