FDA FAERS Adverse Event Reports

110000
Total Reports
60230
Serious Reports
108
Reporter Countries
Clear
25971815 Type 1
Serious
NICOTINELL
Report Version
1
Receive Date
10/29/2025
Receipt Date
10/29/2025
Transmission Date
01/18/2026
Primary Source Country
GB
Occurrence Country
GB
Reporter Country
GB
Reporter Qualification
Consumer
Literature Reference
--
Company Number
GB-UKI-GBR/2025/10/016013
Authority Number
--
Sender Organization
DR REDDYS
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
54.0 yr
Patient Age Group
Adult
Patient Sex
Female
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Drug dependence (v28.1) Unknown

Drugs (1)

NICOTINELL (NICOTINE) Suspect
Route: 065 | Dosage: -- | Form: Unknown | Indication: Ex-tobacco user | Action: Unknown
Auth#: -- | 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": "69974fbf8e900fe3f48c6134", "safetyreportid": "25971815", "authoritynumb": null, "companynumb": "GB-UKI-GBR/2025/10/016013", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "GB", "patient": { "patientonsetage": 54.0, "patientonsetageunit": 801, "patientagegroup": 5, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Drug dependence", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "NICOTINELL", "drugauthorizationnumb": null, "drugbatchnumb": "Unknown", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Unknown", "drugadministrationroute": "065", "drugindication": "Ex-tobacco user", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "NICOTINE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "GB", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "GB", "quarter": "2025Q4", "receiptdate": "2025-10-29T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-29T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "DR REDDYS" }, "serious": 1, "seriousnesscongenitalanomali": null, "seriousnessdeath": null, "seriousnessdisabling": null, "seriousnesshospitalization": null, "seriousnesslifethreatening": null, "seriousnessother": 1, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-18T00:00:00", "transmissiondateformat": "102" }
25971812 Type 1
Non-Serious
NEMLUVIO
Report Version
1
Receive Date
10/29/2025
Receipt Date
10/29/2025
Transmission Date
01/18/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Consumer
Literature Reference
--
Company Number
US-GALDERMA-US2025019674
Authority Number
--
Sender Organization
GALDERMA
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 (2)

Device malfunction (v28.1) Recovered
Inappropriate schedule of product administration (v28.1) Recovered

Drugs (1)

NEMLUVIO (NEMOLIZUMAB-ILTO) Suspect
Route: 058 | Dosage: UNK | Form: Injection | Indication: Neurodermatitis | Action: Not Applicable
Auth#: 761390 | Batch#: B000367382 | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250101

Report Duplicates (1)

100325: GL-100325-39669-0043487

Raw JSON (click to expand)

{ "_id": "69974fbf8e900fe3f48c6133", "safetyreportid": "25971812", "authoritynumb": null, "companynumb": "US-GALDERMA-US2025019674", "duplicate": 1, "fulfillexpeditecriteria": 2, "occurcountry": "US", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": null, "patientsex": null, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Device malfunction", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Inappropriate schedule of product administration", "reactionoutcome": 1 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "NEMLUVIO", "drugauthorizationnumb": "761390", "drugbatchnumb": "B000367382", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": "Injection", "drugadministrationroute": "058", "drugindication": "Neurodermatitis", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "NEMOLIZUMAB-ILTO" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250101" }, "primarysource": { "reportercountry": "US", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-29T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-29T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "100325", "duplicatenumb": "GL-100325-39669-0043487" } ], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "GALDERMA" }, "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" }
25971813 Type 1
Non-Serious
NEMLUVIO
Report Version
1
Receive Date
10/29/2025
Receipt Date
10/29/2025
Transmission Date
01/18/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Physician
Literature Reference
--
Company Number
US-GALDERMA-US2025019657
Authority Number
--
Sender Organization
GALDERMA
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 (3)

Incorrect dose administered (v28.1) Recovered
Device use issue (v28.1) Recovered
Device leakage (v28.1) Recovered

Drugs (1)

NEMLUVIO (NEMOLIZUMAB-ILTO) Suspect
Route: 058 | Dosage: UNK | Form: Injection | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: 761390 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --

Clinical Narrative

--

Report Duplicates (1)

100325: GL-100325-39693-0043476

Raw JSON (click to expand)

{ "_id": "69974fbf8e900fe3f48c6132", "safetyreportid": "25971813", "authoritynumb": null, "companynumb": "US-GALDERMA-US2025019657", "duplicate": 1, "fulfillexpeditecriteria": 2, "occurcountry": "US", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": null, "patientsex": null, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Incorrect dose administered", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Device use issue", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Device leakage", "reactionoutcome": 1 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "NEMLUVIO", "drugauthorizationnumb": "761390", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": "Injection", "drugadministrationroute": "058", "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": "NEMOLIZUMAB-ILTO" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "US", "qualification": 1, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-29T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-29T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "100325", "duplicatenumb": "GL-100325-39693-0043476" } ], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "GALDERMA" }, "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" }
25971808 Type 1
Serious
DOXYCYCLINE
Report Version
1
Receive Date
10/29/2025
Receipt Date
10/29/2025
Transmission Date
01/17/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Physician
Literature Reference
Nathoo R, Siddiqui F. Successful treatment of confluent and reticulated papillomatosis with calcipotriene and tretinoin: a novel topical regimen. Journal of Clinical and Asthetic Dermatology. 2025;18(9):55?57
Company Number
US-MLMSERVICE-20251006-PI670014-00129-1
Authority Number
--
Sender Organization
LUPIN
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
25.0 yr
Patient Age Group
--
Patient Sex
Male
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Abdominal discomfort (v28.1) Unknown

Drugs (1)

DOXYCYCLINE (DOXYCYCLINE) Suspect
Route: 065 | Dosage: 100 MILLIGRAM, BID | Form: -- | Indication: Confluent and reticulate papillomatosis | Action: Withdrawn
Auth#: 201678 | Batch#: Unknown | Structured Dosage: 100.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 2.0 wk | Rechallenge: Unknown | Additional: --
Recurrences: --

Clinical Narrative

--

Report Duplicates (1)

Wipro: IN-Wipro-4093395-426821

Raw JSON (click to expand)

{ "_id": "69974fbf8e900fe3f48c6130", "safetyreportid": "25971808", "authoritynumb": null, "companynumb": "US-MLMSERVICE-20251006-PI670014-00129-1", "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "US", "patient": { "patientonsetage": 25.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": null, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Abdominal discomfort", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "DOXYCYCLINE", "drugauthorizationnumb": "201678", "drugbatchnumb": "Unknown", "drugstructuredosagenumb": 100.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "100 MILLIGRAM, BID", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": "Confluent and reticulate papillomatosis", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": 2.0, "drugtreatmentdurationunit": 803, "drugrecurreadministration": 3, "drugadditional": null, "actiondrug": 1, "activesubstance": { "activesubstancename": "DOXYCYCLINE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "US", "qualification": 1, "literaturereference": "Nathoo R, Siddiqui F. Successful treatment of confluent and reticulated papillomatosis with calcipotriene and tretinoin: a novel topical regimen. Journal of Clinical and Asthetic Dermatology. 2025;18(9):55?57" }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-29T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-29T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "Wipro", "duplicatenumb": "IN-Wipro-4093395-426821" } ], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "LUPIN" }, "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" }
25971810 Type 1
Non-Serious
NEMLUVIO
Report Version
1
Receive Date
10/29/2025
Receipt Date
10/29/2025
Transmission Date
01/18/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Consumer
Literature Reference
--
Company Number
US-GALDERMA-US2025019658
Authority Number
--
Sender Organization
GALDERMA
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 (3)

Headache (v28.1) Unknown
Pain (v28.1) Unknown
Incorrect dose administered (v28.1) Recovered

Drugs (1)

NEMLUVIO (NEMOLIZUMAB-ILTO) Suspect
Route: 058 | Dosage: 30 MILLIGRAM | Form: Injection | Indication: Neurodermatitis | Action: Unknown
Auth#: 761390 | Batch#: -- | Structured Dosage: 30.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 09/05/2025 | End: 09/05/2025 | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250905

Report Duplicates (1)

100325: GL-100325-39666

Raw JSON (click to expand)

{ "_id": "69974fbf8e900fe3f48c612f", "safetyreportid": "25971810", "authoritynumb": null, "companynumb": "US-GALDERMA-US2025019658", "duplicate": 1, "fulfillexpeditecriteria": 2, "occurcountry": "US", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": null, "patientsex": null, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Headache", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Pain", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Incorrect dose administered", "reactionoutcome": 1 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "NEMLUVIO", "drugauthorizationnumb": "761390", "drugbatchnumb": null, "drugstructuredosagenumb": 30.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "30 MILLIGRAM", "drugdosageform": "Injection", "drugadministrationroute": "058", "drugindication": "Neurodermatitis", "drugstartdateformat": "102", "drugstartdate": "2025-09-05T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-09-05T00:00:00", "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "NEMOLIZUMAB-ILTO" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250905" }, "primarysource": { "reportercountry": "US", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-29T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-29T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "100325", "duplicatenumb": "GL-100325-39666" } ], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "GALDERMA" }, "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" }
25971809 Type 2
Serious
TECENTRIQ, AVASTIN
Report Version
1
Receive Date
10/29/2025
Receipt Date
10/29/2025
Transmission Date
01/18/2026
Primary Source Country
IN
Occurrence Country
IN
Reporter Country
IN
Reporter Qualification
Consumer
Literature Reference
--
Company Number
IN-ROCHE-10000421699
Authority Number
--
Sender Organization
ROCHE
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
52.0 yr
Patient Age Group
Adult
Patient Sex
Male
Patient Weight
65.0 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Death (v28.1) Fatal

Drugs (2)

TECENTRIQ (ATEZOLIZUMAB) Suspect
Route: 042 | Dosage: -- | Form: Injection | Indication: Hepatocellular carcinoma | Action: Not Applicable
Auth#: -- | Batch#: Unknown | Structured Dosage: 1200.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 09/17/2025 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
AVASTIN (BEVACIZUMAB) Suspect
Route: 042 | Dosage: -- | Form: Injection | Indication: Hepatocellular carcinoma | Action: Not Applicable
Auth#: -- | Batch#: Unknown | Structured Dosage: 400.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 09/17/2025 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20251026

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69974fbf8e900fe3f48c612c", "safetyreportid": "25971809", "authoritynumb": null, "companynumb": "IN-ROCHE-10000421699", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "IN", "patient": { "patientonsetage": 52.0, "patientonsetageunit": 801, "patientagegroup": 5, "patientweight": 65.0, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Death", "reactionoutcome": 5 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "TECENTRIQ", "drugauthorizationnumb": null, "drugbatchnumb": "Unknown", "drugstructuredosagenumb": 1200.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Injection", "drugadministrationroute": "042", "drugindication": "Hepatocellular carcinoma", "drugstartdateformat": "102", "drugstartdate": "2025-09-17T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "ATEZOLIZUMAB" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "AVASTIN", "drugauthorizationnumb": null, "drugbatchnumb": "Unknown", "drugstructuredosagenumb": 400.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Injection", "drugadministrationroute": "042", "drugindication": "Hepatocellular carcinoma", "drugstartdateformat": "102", "drugstartdate": "2025-09-17T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "BEVACIZUMAB" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20251026" }, "primarysource": { "reportercountry": "IN", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "IN", "quarter": "2025Q4", "receiptdate": "2025-10-29T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-29T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 2, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "ROCHE" }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 1, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": null, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-18T00:00:00", "transmissiondateformat": "102" }
25971804 Type 1
Non-Serious
XDEMVY
Report Version
1
Receive Date
10/29/2025
Receipt Date
10/29/2025
Transmission Date
01/17/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Physician
Literature Reference
--
Company Number
US-TARSUS PHARMACEUTICALS-TSP-US-2025-001012
Authority Number
--
Sender Organization
Tarsus Pharmaceuticals
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)

Off label use (v28.1) Unknown

Drugs (1)

XDEMVY (LOTILANER) Suspect
Route: 065 | Dosage: UNK | Form: Ophthalmic Solution | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: 217603 | Batch#: Unknown | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69974fbf8e900fe3f48c612a", "safetyreportid": "25971804", "authoritynumb": null, "companynumb": "US-TARSUS PHARMACEUTICALS-TSP-US-2025-001012", "duplicate": null, "fulfillexpeditecriteria": 2, "occurcountry": "US", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": null, "patientsex": null, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Off label use", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "XDEMVY", "drugauthorizationnumb": "217603", "drugbatchnumb": "Unknown", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": "Ophthalmic Solution", "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": "LOTILANER" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "US", "qualification": 1, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-29T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-29T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "Tarsus Pharmaceuticals" }, "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" }
25971802 Type 2
Serious
IXAZOMIB, IXAZOMIB
Report Version
1
Receive Date
10/29/2025
Receipt Date
10/29/2025
Transmission Date
01/17/2026
Primary Source Country
CA
Occurrence Country
CA
Reporter Country
CA
Reporter Qualification
Consumer
Literature Reference
--
Company Number
CA-TAKEDA-2024TUS087143
Authority Number
--
Sender Organization
TAKEDA
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
60.0 yr
Patient Age Group
--
Patient Sex
Female
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (5)

Plasma cell myeloma (v28.1) Unknown
Light chain analysis increased (v28.1) Unknown
Cough (v28.1) Unknown
Off label use (v28.1) Unknown
Nasopharyngitis (v28.1) Unknown

Drugs (2)

IXAZOMIB (IXAZOMIB) Suspect
Route: -- | Dosage: 3 MILLIGRAM | Form: Capsule | Indication: Plasma cell myeloma | Action: Withdrawn
Auth#: 208462 | Batch#: -- | Structured Dosage: 3.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: --
Recurrences: --
IXAZOMIB (IXAZOMIB) Suspect
Route: -- | Dosage: 4 MILLIGRAM | Form: Capsule | Indication: -- | Action: Withdrawn
Auth#: 208462 | Batch#: -- | Structured Dosage: 4.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: --
Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69974fbf8e900fe3f48c6129", "safetyreportid": "25971802", "authoritynumb": null, "companynumb": "CA-TAKEDA-2024TUS087143", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "CA", "patient": { "patientonsetage": 60.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Plasma cell myeloma", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Light chain analysis increased", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Cough", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Off label use", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Nasopharyngitis", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "IXAZOMIB", "drugauthorizationnumb": "208462", "drugbatchnumb": null, "drugstructuredosagenumb": 3.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "3 MILLIGRAM", "drugdosageform": "Capsule", "drugadministrationroute": null, "drugindication": "Plasma cell myeloma", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": null, "actiondrug": 1, "activesubstance": { "activesubstancename": "IXAZOMIB" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "IXAZOMIB", "drugauthorizationnumb": "208462", "drugbatchnumb": null, "drugstructuredosagenumb": 4.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "4 MILLIGRAM", "drugdosageform": "Capsule", "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": null, "actiondrug": 1, "activesubstance": { "activesubstancename": "IXAZOMIB" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "CA", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "CA", "quarter": "2025Q4", "receiptdate": "2025-10-29T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-29T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 2, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "TAKEDA" }, "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" }
25971801 Type 1
Serious
DOXORUBICIN, DOXORUBICIN, ETOPOSIDE (+7 more)
Report Version
1
Receive Date
10/29/2025
Receipt Date
10/29/2025
Transmission Date
01/18/2026
Primary Source Country
JP
Occurrence Country
JP
Reporter Country
JP
Reporter Qualification
Other Health Professional
Literature Reference
--
Company Number
JP-MLMSERVICE-20251015-PI676470-00140-1
Authority Number
--
Sender Organization
BAXTER
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
64.0 yr
Patient Age Group
--
Patient Sex
Male
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (4)

Bronchopulmonary aspergillosis (v28.1) Unknown
Performance status decreased (v28.1) Unknown
Dysphagia (v28.1) Unknown
Febrile neutropenia (v28.1) Unknown

Drugs (10)

DOXORUBICIN (DOXORUBICIN) Suspect
Route: 065 | Dosage: THREE CYCLES | Form: Unknown | Indication: Burkitt^s lymphoma | Action: Unknown
Auth#: 050718 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
DOXORUBICIN (DOXORUBICIN) Suspect
Route: -- | Dosage: -- | Form: Unknown | Indication: Diffuse large B-cell lymphoma recurrent | Action: Unknown
Auth#: 050718 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
ETOPOSIDE (ETOPOSIDE) Suspect
Route: 065 | Dosage: THREE CYCLES | Form: -- | Indication: Burkitt^s lymphoma | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
ETOPOSIDE (ETOPOSIDE) Suspect
Route: -- | Dosage: -- | Form: -- | Indication: Diffuse large B-cell lymphoma recurrent | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
CYCLOPHOSPHAMIDE (CYCLOPHOSPHAMIDE) Suspect
Route: 065 | Dosage: THREE CYCLES | Form: -- | Indication: Burkitt^s lymphoma | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
CYCLOPHOSPHAMIDE (CYCLOPHOSPHAMIDE) Suspect
Route: -- | Dosage: -- | Form: -- | Indication: Diffuse large B-cell lymphoma recurrent | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
PREDNISONE (PREDNISONE) Suspect
Route: 065 | Dosage: THREE CYCLES | Form: -- | Indication: Burkitt^s lymphoma | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
PREDNISONE (PREDNISONE) Suspect
Route: -- | Dosage: -- | Form: -- | Indication: Diffuse large B-cell lymphoma recurrent | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
VINCRISTINE (VINCRISTINE) Suspect
Route: 065 | Dosage: THREE CYCLES | Form: -- | Indication: Burkitt^s lymphoma | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
VINCRISTINE (VINCRISTINE) Suspect
Route: -- | Dosage: -- | Form: -- | Indication: Diffuse large B-cell lymphoma recurrent | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --

Clinical Narrative

--

Report Duplicates (2)

MLM Tracking number: PI676470-00128
MLM Tracking number: PI676470-00271

Raw JSON (click to expand)

{ "_id": "69974fbf8e900fe3f48c6128", "safetyreportid": "25971801", "authoritynumb": null, "companynumb": "JP-MLMSERVICE-20251015-PI676470-00140-1", "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "JP", "patient": { "patientonsetage": 64.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": null, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Bronchopulmonary aspergillosis", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Performance status decreased", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Dysphagia", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Febrile neutropenia", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "DOXORUBICIN", "drugauthorizationnumb": "050718", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "THREE CYCLES", "drugdosageform": "Unknown", "drugadministrationroute": "065", "drugindication": "Burkitt^s lymphoma", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "DOXORUBICIN" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "DOXORUBICIN", "drugauthorizationnumb": "050718", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Unknown", "drugadministrationroute": null, "drugindication": "Diffuse large B-cell lymphoma recurrent", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "DOXORUBICIN" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "ETOPOSIDE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "THREE CYCLES", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": "Burkitt^s lymphoma", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "ETOPOSIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "ETOPOSIDE", "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": "Diffuse large B-cell lymphoma recurrent", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "ETOPOSIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "CYCLOPHOSPHAMIDE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "THREE CYCLES", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": "Burkitt^s lymphoma", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "CYCLOPHOSPHAMIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "CYCLOPHOSPHAMIDE", "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": "Diffuse large B-cell lymphoma recurrent", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "CYCLOPHOSPHAMIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "PREDNISONE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "THREE CYCLES", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": "Burkitt^s lymphoma", "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": "PREDNISONE", "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": "Diffuse large B-cell lymphoma recurrent", "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": "VINCRISTINE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "THREE CYCLES", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": "Burkitt^s lymphoma", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "VINCRISTINE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "VINCRISTINE", "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": "Diffuse large B-cell lymphoma recurrent", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "VINCRISTINE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "JP", "qualification": 3, "literaturereference": null }, "primarysourcecountry": "JP", "quarter": "2025Q4", "receiptdate": "2025-10-29T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-29T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "MLM Tracking number", "duplicatenumb": "PI676470-00128" }, { "duplicatesource": "MLM Tracking number", "duplicatenumb": "PI676470-00271" } ], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "BAXTER" }, "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" }
25971794 Type 1
Serious
NORCO, NORCO, MORPHINE SULFATE (+44 more)
Report Version
1
Receive Date
10/29/2025
Receipt Date
10/29/2025
Transmission Date
01/18/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Physician
Literature Reference
--
Company Number
US-ACTAVIS-2008-02350
Authority Number
--
Sender Organization
TEVA
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
No
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
43.0 yr
Patient Age Group
--
Patient Sex
Female
Patient Weight
61.224 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (10)

Drug abuse (v28.1) Unknown
Tooth loss (v28.1) Unknown
Drug dependence (v28.1) Unknown
Partner stress (v28.1) Unknown
Abnormal behaviour (v28.1) Unknown
Dysarthria (v28.1) Unknown
Depression (v28.1) Unknown
Tooth abscess (v28.1) Unknown
Dental caries (v28.1) Unknown
Overdose (v28.1) Unknown

Drugs (47)

NORCO (ACETAMINOPHEN\HYDROCODONE BITARTRATE) Suspect
Route: 065 | Dosage: DOSAGE TEXT: 20 MG, Q4H | Form: Tablet | Indication: Back pain | Action: Withdrawn
Auth#: 206470 | Batch#: -- | Structured Dosage: 20.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 4.0 hr | Cumulative: -- (unit: --)
Start: -- | End: 08/22/2002 | Duration: -- -- | Rechallenge: Unknown | Additional: --
Recurrences: --
NORCO (ACETAMINOPHEN\HYDROCODONE BITARTRATE) Suspect
Route: 065 | Dosage: DOSAGE TEXT: UNK, UNKNOWN? 10/325 (WATSON LABORATORIES) | Form: Tablet | Indication: Back pain | Action: Withdrawn
Auth#: 206470 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 01/05/2000 | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: --
Recurrences: --
MORPHINE SULFATE (MORPHINE SULFATE) Suspect
Route: 065 | Dosage: DOSAGE TEXT: 15 MG, UNKNOWN | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: 079040 | Batch#: -- | Structured Dosage: 15.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 12/10/2004 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
ENDOCET (ACETAMINOPHEN\OXYCODONE HYDROCHLORIDE) Suspect
Route: 065 | Dosage: DOSAGE TEXT: 5/325 MG, UNKNOWN | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 03/29/2006 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
VICODIN ES (ACETAMINOPHEN\HYDROCODONE BITARTRATE) Suspect
Route: 065 | Dosage: DOSAGE TEXT: 7.5/750 MG, UNKNOWN | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 05/07/2004 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
KADIAN (MORPHINE SULFATE) Suspect
Route: 065 | Dosage: DOSAGE TEXT: 100 MG, BID?^ZENECA^ | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 100.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 0.5 day | Cumulative: -- (unit: --)
Start: 08/28/2006 | End: 01/30/2007 | Duration: 156.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
DILAUDID (HYDROMORPHONE HYDROCHLORIDE) Suspect
Route: 048 | Dosage: TIME INTERVAL: 0.333 DAYS: DOSAGE TEXT: 4 MG, TID | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 4.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 09/19/2006 | End: 01/31/2007 | Duration: 135.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
DILAUDID (HYDROMORPHONE HYDROCHLORIDE) Suspect
Route: 048 | Dosage: DOSAGE TEXT: 4 MG, QID | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 4.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 02/13/2006 | End: 09/18/2006 | Duration: 218.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
VALIUM (DIAZEPAM) Concomitant
Route: 065 | Dosage: DOSAGE TEXT: UNK, UNKNOWN | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 01/04/2000 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
ZANAFLEX (TIZANIDINE HYDROCHLORIDE) Concomitant
Route: 065 | Dosage: DOSAGE TEXT: UNK, UNKNOWN | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 01/05/2000 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
DESYREL (TRAZODONE HYDROCHLORIDE) Concomitant
Route: 065 | Dosage: DOSAGE TEXT: UNK, UNKNOWN | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 01/30/2006 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
DESYREL (TRAZODONE HYDROCHLORIDE) Concomitant
Route: 065 | Dosage: DOSAGE TEXT: UNK, UNKNOWN | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 01/17/2000 | End: 08/22/2002 | Duration: 949.0 day | Rechallenge: -- | Additional: --
Recurrences: --
DESYREL (TRAZODONE HYDROCHLORIDE) Concomitant
Route: 065 | Dosage: DOSAGE TEXT: UNK, UNKNOWN | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 08/23/2002 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
ATIVAN (LORAZEPAM) Concomitant
Route: 065 | Dosage: DOSAGE TEXT: UNK, UNKNOWN | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 02/02/2007 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
ATIVAN (LORAZEPAM) Concomitant
Route: 065 | Dosage: DOSAGE TEXT: UNK, UNKNOWN | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 04/11/2002 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
ZOLOFT (SERTRALINE HYDROCHLORIDE) Concomitant
Route: 065 | Dosage: DOSAGE TEXT: UNK, UNKNOWN | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 08/23/2002 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
ZOLOFT (SERTRALINE HYDROCHLORIDE) Concomitant
Route: 065 | Dosage: DOSAGE TEXT: UNK, UNKNOWN | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 12/07/2001 | End: 08/22/2002 | Duration: 37.0 wk | Rechallenge: -- | Additional: --
Recurrences: --
ZOLOFT (SERTRALINE HYDROCHLORIDE) Concomitant
Route: 065 | Dosage: DOSAGE TEXT: UNK, UNKNOWN | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 03/07/2001 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
ACTIQ (FENTANYL CITRATE) Suspect
Route: 002 | Dosage: DOSAGE TEXT: VARIBLE DOSING | Form: -- | Indication: Back pain | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 05/06/2002 | End: 01/30/2007 | Duration: 1731.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
NEURONTIN (GABAPENTIN) Concomitant
Route: 065 | Dosage: DOSAGE TEXT: UNK, UNKNOWN | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 06/09/2003 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
NEURONTIN (GABAPENTIN) Concomitant
Route: 065 | Dosage: DOSAGE TEXT: UNK, UNKNOWN | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 09/03/2002 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
NEURONTIN (GABAPENTIN) Concomitant
Route: 065 | Dosage: DOSAGE TEXT: UNK, UNKNOWN | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 08/22/2002 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
NEURONTIN (GABAPENTIN) Concomitant
Route: 065 | Dosage: DOSAGE TEXT: UNK, UNKNOWN | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 01/04/2002 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
NEURONTIN (GABAPENTIN) Concomitant
Route: 065 | Dosage: DOSAGE TEXT: UNK, UNKNOWN | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 11/09/2001 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
SEROQUEL (QUETIAPINE FUMARATE) Concomitant
Route: 065 | Dosage: DOSAGE TEXT: UNK, UNKNOWN | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 05/19/2005 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
SEROQUEL (QUETIAPINE FUMARATE) Concomitant
Route: 065 | Dosage: DOSAGE TEXT: UNK, UNKNOWN | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 04/21/2005 | End: 05/18/2005 | Duration: 4.0 wk | Rechallenge: -- | Additional: --
Recurrences: --
SEROQUEL (QUETIAPINE FUMARATE) Concomitant
Route: 065 | Dosage: DOSAGE TEXT: UNK, UNKNOWN | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 09/08/2004 | End: 04/20/2005 | Duration: 225.0 day | Rechallenge: -- | Additional: --
Recurrences: --
SEROQUEL (QUETIAPINE FUMARATE) Concomitant
Route: 065 | Dosage: DOSAGE TEXT: UNK, UNKNOWN | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 06/09/2003 | End: 09/07/2004 | Duration: 457.0 day | Rechallenge: -- | Additional: --
Recurrences: --
TOPAMAX (TOPIRAMATE) Concomitant
Route: 065 | Dosage: DOSAGE TEXT: UNK, UNKNOWN | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 11/09/2005 | End: 01/01/2006 | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
TOPAMAX (TOPIRAMATE) Concomitant
Route: 065 | Dosage: DOSAGE TEXT: UNK, UNKNOWN | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 08/22/2002 | End: 11/08/2005 | Duration: 1175.0 day | Rechallenge: -- | Additional: --
Recurrences: --
WELLBUTRIN (BUPROPION HYDROCHLORIDE) Concomitant
Route: 065 | Dosage: DOSAGE TEXT: UNK, UNKNOWN | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 05/26/2005 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
WELLBUTRIN (BUPROPION HYDROCHLORIDE) Concomitant
Route: 065 | Dosage: DOSAGE TEXT: UNK, UNKNOWN | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 05/18/2005 | End: 05/25/2005 | Duration: 8.0 day | Rechallenge: -- | Additional: --
Recurrences: --
LORCET (ACETAMINOPHEN\HYDROCODONE BITARTRATE) Suspect
Route: 065 | Dosage: TIME INTERVAL: AS NECESSARY: DOSAGE TEXT: UNK, PRN | Form: -- | Indication: Back pain | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 10/27/1999 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
OXYCONTIN (OXYCODONE HYDROCHLORIDE) Suspect
Route: 065 | Dosage: DOSAGE TEXT: 100 MG, DAILY | Form: -- | Indication: Back pain | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 100.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: 08/22/2002 | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
OXYCONTIN (OXYCODONE HYDROCHLORIDE) Suspect
Route: 065 | Dosage: DOSAGE TEXT: 140 MG, DAILY | Form: -- | Indication: Back pain | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 140.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 10/27/1999 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
ROXICET (ACETAMINOPHEN\OXYCODONE HYDROCHLORIDE) Suspect
Route: 065 | Dosage: DOSAGE TEXT: 5/325 MG, UNKNOWN | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 11/09/2000 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
STADOL NS (BUTORPHANOL TARTRATE) Suspect
Route: 045 | Dosage: DOSAGE TEXT: 10 MG/ML, UNK | Form: -- | Indication: Back pain | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 11/09/2001 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
OXYCODONE HYDROCHLORIDE (OXYCODONE HYDROCHLORIDE) Suspect
Route: 065 | Dosage: DOSAGE TEXT: 10 MG, QID | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 10.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 01/01/2002 | End: 01/01/2002 | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
METHADONE (METHADONE HYDROCHLORIDE) Suspect
Route: 065 | Dosage: DOSAGE TEXT: 10 MG, QID | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 10.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 06/10/2003 | End: 09/07/2004 | Duration: 456.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
METHADONE (METHADONE HYDROCHLORIDE) Suspect
Route: 065 | Dosage: TIME INTERVAL: 0.333 DAYS: DOSAGE TEXT: 20 MG, TID | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 20.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 09/04/2002 | End: 06/09/2003 | Duration: 279.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
METHADONE (METHADONE HYDROCHLORIDE) Suspect
Route: 065 | Dosage: TIME INTERVAL: 0.333 DAYS: DOSAGE TEXT: 10 MG, TID | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 10.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 08/22/2002 | End: 09/03/2002 | Duration: 13.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
DURAGESIC (FENTANYL) Suspect
Route: 062 | Dosage: DOSAGE TEXT: 75 UG, Q1H | Form: -- | Indication: Back pain | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 75.0 (unit: 004) | Separate Dosage#: 1.0 | Interval: 1.0 hr | Cumulative: -- (unit: --)
Start: 02/03/2007 | End: 05/01/2007 | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
DURAGESIC (FENTANYL) Suspect
Route: 062 | Dosage: DOSAGE TEXT: 100 UG, Q1H | Form: -- | Indication: Back pain | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 100.0 (unit: 004) | Separate Dosage#: 1.0 | Interval: 1.0 hr | Cumulative: -- (unit: --)
Start: 01/31/2006 | End: 02/02/2007 | Duration: 368.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
DURAGESIC (FENTANYL) Suspect
Route: 062 | Dosage: DOSAGE TEXT: 75 UG, Q1H | Form: -- | Indication: Back pain | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 75.0 (unit: 004) | Separate Dosage#: 1.0 | Interval: 1.0 hr | Cumulative: -- (unit: --)
Start: 11/09/2005 | End: 01/30/2006 | Duration: 83.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
DURAGESIC (FENTANYL) Suspect
Route: 062 | Dosage: DOSAGE TEXT: 100 UG, Q1H | Form: -- | Indication: Back pain | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 100.0 (unit: 004) | Separate Dosage#: 1.0 | Interval: 1.0 hr | Cumulative: -- (unit: --)
Start: 05/19/2005 | End: 11/08/2005 | Duration: 174.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
DURAGESIC (FENTANYL) Suspect
Route: 062 | Dosage: DOSAGE TEXT: 150 UG, Q1H | Form: -- | Indication: Back pain | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 150.0 (unit: 004) | Separate Dosage#: 1.0 | Interval: 1.0 hr | Cumulative: -- (unit: --)
Start: 02/25/2005 | End: 05/18/2005 | Duration: 83.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
DURAGESIC (FENTANYL) Suspect
Route: 062 | Dosage: DOSAGE TEXT: 75 UG, Q1H | Form: -- | Indication: Back pain | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 75.0 (unit: 004) | Separate Dosage#: 1.0 | Interval: 1.0 hr | Cumulative: -- (unit: --)
Start: 09/07/2004 | End: 02/24/2005 | Duration: 171.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20020701

Report Duplicates (2)

Unnamed Attorney: 2008GPS00208
E2B Company Number: US-ACTAVIS-2008-02350

Raw JSON (click to expand)

{ "_id": "69974fbf8e900fe3f48c6126", "safetyreportid": "25971794", "authoritynumb": null, "companynumb": "US-ACTAVIS-2008-02350", "duplicate": 1, "fulfillexpeditecriteria": 2, "occurcountry": "US", "patient": { "patientonsetage": 43.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": 61.224, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Drug abuse", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Tooth loss", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Drug dependence", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Partner stress", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Abnormal behaviour", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Dysarthria", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Depression", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Tooth abscess", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Dental caries", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Overdose", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "NORCO", "drugauthorizationnumb": "206470", "drugbatchnumb": null, "drugstructuredosagenumb": 20.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 4.0, "drugintervaldosagedefinition": 805, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "DOSAGE TEXT: 20 MG, Q4H", "drugdosageform": "Tablet", "drugadministrationroute": "065", "drugindication": "Back pain", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": "102", "drugenddate": "2002-08-22T00:00:00", "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": null, "actiondrug": 1, "activesubstance": { "activesubstancename": "ACETAMINOPHEN\\HYDROCODONE BITARTRATE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "NORCO", "drugauthorizationnumb": "206470", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "DOSAGE TEXT: UNK, UNKNOWN? 10/325 (WATSON LABORATORIES)", "drugdosageform": "Tablet", "drugadministrationroute": "065", "drugindication": "Back pain", "drugstartdateformat": "102", "drugstartdate": "2000-01-05T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": null, "actiondrug": 1, "activesubstance": { "activesubstancename": "ACETAMINOPHEN\\HYDROCODONE BITARTRATE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "MORPHINE SULFATE", "drugauthorizationnumb": "079040", "drugbatchnumb": null, "drugstructuredosagenumb": 15.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "DOSAGE TEXT: 15 MG, UNKNOWN", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": "Product used for unknown indication", "drugstartdateformat": "102", "drugstartdate": "2004-12-10T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "MORPHINE SULFATE" }, "drugrecurrence": [] }, { 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"receiptdateformat": "102", "receivedate": "2025-10-29T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "Unnamed Attorney", "duplicatenumb": "2008GPS00208" }, { "duplicatesource": "E2B Company Number", "duplicatenumb": "US-ACTAVIS-2008-02350" } ], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "TEVA" }, "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" }