FDA FAERS Adverse Event Reports

111000
Total Reports
60668
Serious Reports
108
Reporter Countries
Clear
25963538 Type 1
Non-Serious
BIMZELX, BIMZELX
Report Version
1
Receive Date
10/27/2025
Receipt Date
10/27/2025
Transmission Date
01/17/2026
Primary Source Country
US
Occurrence Country
--
Reporter Country
US
Reporter Qualification
Other Health Professional
Literature Reference
--
Company Number
US-UCBSA-2025029636
Authority Number
--
Sender Organization
UCB
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
No
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
31.0 yr
Patient Age Group
--
Patient Sex
--
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Psoriasis (v28.1) Unknown
Acne (v28.1) Unknown

Drugs (2)

BIMZELX (BIMEKIZUMAB-BKZX) Suspect
Route: -- | Dosage: 320 MILLIGRAM, EV 4 WEEKS | Form: Solution for injection in pre-filled pen | Indication: Psoriasis | Action: Dose Not Changed
Auth#: 761151 | Batch#: -- | Structured Dosage: 320.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 4.0 wk | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: --
Recurrences: --
BIMZELX (BIMEKIZUMAB-BKZX) Suspect
Route: -- | Dosage: 320 MILLIGRAM, EV 8 WEEKS | Form: Solution for injection in pre-filled pen | Indication: -- | Action: Dose Not Changed
Auth#: 761151 | Batch#: -- | Structured Dosage: 320.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 8.0 wk | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: --
Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435bd3b3830196fa582a2", "safetyreportid": "25963538", "authoritynumb": null, "companynumb": "US-UCBSA-2025029636", "duplicate": null, "fulfillexpeditecriteria": 2, "occurcountry": null, "patient": { "patientonsetage": 31.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": null, "patientsex": null, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Psoriasis", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Acne", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "BIMZELX", "drugauthorizationnumb": "761151", "drugbatchnumb": null, "drugstructuredosagenumb": 320.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 4.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "320 MILLIGRAM, EV 4 WEEKS", "drugdosageform": "Solution for injection in pre-filled pen", "drugadministrationroute": null, "drugindication": "Psoriasis", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "BIMEKIZUMAB-BKZX" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "BIMZELX", "drugauthorizationnumb": "761151", "drugbatchnumb": null, "drugstructuredosagenumb": 320.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 8.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "320 MILLIGRAM, EV 8 WEEKS", "drugdosageform": "Solution for injection in pre-filled pen", "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "BIMEKIZUMAB-BKZX" }, "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": "UCB" }, "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" }
25963536 Type 1
Non-Serious
JOURNAVX
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
Physician
Literature Reference
--
Company Number
US-VERTEX PHARMACEUTICALS-2025-017325
Authority Number
--
Sender Organization
VERTEX
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 (1)

Pruritus (v28.1) Recovered

Drugs (1)

JOURNAVX (SUZETRIGINE) Suspect
Route: 048 | Dosage: UNK | Form: Film-coated tablet | Indication: Pain | Action: Withdrawn
Auth#: 219209 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435bd3b3830196fa58292", "safetyreportid": "25963536", "authoritynumb": null, "companynumb": "US-VERTEX PHARMACEUTICALS-2025-017325", "duplicate": null, "fulfillexpeditecriteria": 2, "occurcountry": "US", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": null, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Pruritus", "reactionoutcome": 1 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "JOURNAVX", "drugauthorizationnumb": "219209", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": "Film-coated tablet", "drugadministrationroute": "048", "drugindication": "Pain", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "SUZETRIGINE" }, "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": "VERTEX" }, "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" }
25963534 Type 1
Non-Serious
JOURNAVX, JOURNAVX
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-VERTEX PHARMACEUTICALS-2025-017678
Authority Number
--
Sender Organization
VERTEX
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
No
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
--
Patient Age Group
--
Patient Sex
Female
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Swollen tongue (v28.1) Not Recovered
Off label use (v28.1) Unknown

Drugs (2)

JOURNAVX (SUZETRIGINE) Suspect
Route: 048 | Dosage: 100 MG, SINGLE (LOADING DOSE) | Form: Film-coated tablet | Indication: Nerve compression | Action: Dose Not Changed
Auth#: 219209 | Batch#: -- | Structured Dosage: 100.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 100.0 (unit: 003)
Start: 10/20/2025 | End: 10/20/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: --
Recurrences: --
JOURNAVX (SUZETRIGINE) Suspect
Route: 048 | Dosage: 50 MG | Form: Film-coated tablet | Indication: -- | Action: Dose Not Changed
Auth#: 219209 | Batch#: -- | Structured Dosage: 50.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: 100.0 (unit: 003)
Start: 10/21/2025 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20251020

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435bd3b3830196fa58291", "safetyreportid": "25963534", "authoritynumb": null, "companynumb": "US-VERTEX PHARMACEUTICALS-2025-017678", "duplicate": null, "fulfillexpeditecriteria": 2, "occurcountry": "US", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Swollen tongue", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Off label use", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "JOURNAVX", "drugauthorizationnumb": "219209", "drugbatchnumb": null, "drugstructuredosagenumb": 100.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": 100.0, "drugcumulativedosageunit": "003", "drugdosagetext": "100 MG, SINGLE (LOADING DOSE)", "drugdosageform": "Film-coated tablet", "drugadministrationroute": "048", "drugindication": "Nerve compression", "drugstartdateformat": "102", "drugstartdate": "2025-10-20T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-10-20T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "SUZETRIGINE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "JOURNAVX", "drugauthorizationnumb": "219209", "drugbatchnumb": null, "drugstructuredosagenumb": 50.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": 100.0, "drugcumulativedosageunit": "003", "drugdosagetext": "50 MG", "drugdosageform": "Film-coated tablet", "drugadministrationroute": "048", "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2025-10-21T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "SUZETRIGINE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20251020" }, "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": "VERTEX" }, "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" }
25963537 Type 1
Serious
DICLOFENAC, DICLOFENAC, DICLOFENAC (+73 more)
Report Version
1
Receive Date
10/27/2025
Receipt Date
10/27/2025
Transmission Date
01/17/2026
Primary Source Country
CA
Occurrence Country
CA
Reporter Country
CA
Reporter Qualification
Other Health Professional
Literature Reference
--
Company Number
CA-TEVA-VS-3384280
Authority Number
--
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
44.0 yr
Patient Age Group
--
Patient Sex
--
Patient Weight
78.0 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (22)

Hypoaesthesia (v28.1) Fatal
Night sweats (v28.1) Fatal
Underdose (v28.1) Fatal
Lower limb fracture (v28.1) Fatal
Obesity (v28.1) Fatal
Musculoskeletal stiffness (v28.1) Fatal
X-ray abnormal (v28.1) Fatal
Muscle spasms (v28.1) Fatal
Nasopharyngitis (v28.1) Fatal
Pain in extremity (v28.1) Fatal
Lung disorder (v28.1) Fatal
Synovitis (v28.1) Fatal
Liver injury (v28.1) Fatal
Oedema peripheral (v28.1) Fatal
Impaired healing (v28.1) Fatal
Hypersensitivity (v28.1) Fatal
Injury (v28.1) Fatal
Joint swelling (v28.1) Fatal
Lower respiratory tract infection (v28.1) Fatal
Musculoskeletal pain (v28.1) Fatal
Intentional product use issue (v28.1) Fatal
Muscle injury (v28.1) Fatal

Drugs (76)

DICLOFENAC (DICLOFENAC) Suspect
Route: 065 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: 074514 | Batch#: UNKNOWN | Structured Dosage: 50.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
DICLOFENAC (DICLOFENAC) Suspect
Route: 065 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: 074514 | Batch#: UNKNOWN | Structured Dosage: 50.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
DICLOFENAC (DICLOFENAC) Suspect
Route: 065 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: 074514 | Batch#: UNKNOWN | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
TRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE) Suspect
Route: 065 | Dosage: DOSE FORM: SUSPENSION INTRA-ARTICULAR, ROUTE OF ADMINISTRATION: OTHER | Form: -- | Indication: Rheumatoid arthritis | Action: Unknown
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
SULFAMETHOXAZOLE (SULFAMETHOXAZOLE) Suspect
Route: 065 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
STELARA (USTEKINUMAB) Suspect
Route: 065 | Dosage: DOSE FORM: SOLUTION SUBCUTANEOUS, ROUTE OF ADMINISTRATION: OTHER | Form: -- | Indication: Rheumatoid arthritis | Action: Unknown
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
STELARA (USTEKINUMAB) Suspect
Route: 065 | Dosage: ROUTE OF ADMINISTRATION: OTHER | Form: -- | Indication: Rheumatoid arthritis | Action: Unknown
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 45.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
STELARA (USTEKINUMAB) Suspect
Route: 065 | Dosage: -- | Form: -- | Indication: Rheumatoid arthritis | Action: Unknown
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
PREDNISONE (PREDNISONE) Suspect
Route: 065 | Dosage: ROUTE OF ADMINISTRATION: OTHER | Form: Tablet | Indication: Rheumatoid arthritis | Action: Unknown
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
COSENTYX (SECUKINUMAB) Suspect
Route: 065 | Dosage: ROUTE OF ADMINISTRATION: OTHER | Form: -- | Indication: Rheumatoid arthritis | Action: Unknown
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
COSENTYX (SECUKINUMAB) Suspect
Route: 065 | Dosage: ROUTE OF ADMINISTRATION: OTHER | Form: Solution for injection | Indication: Rheumatoid arthritis | Action: Unknown
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
DILTIAZEM (DILTIAZEM) Suspect
Route: 065 | Dosage: DOSE FORM: CAPSULE, CONTROLLED-DELIVERY, DILTIAZEM CD, ROUTE OF ADMINISTRATION: OTHER | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: 074079 | Batch#: UNKNOWN | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
TOFACITINIB CITRATE (TOFACITINIB CITRATE) Suspect
Route: 065 | Dosage: -- | Form: Tablet | Indication: Rheumatoid arthritis | Action: Unknown
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 10.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
TOFACITINIB CITRATE (TOFACITINIB CITRATE) Suspect
Route: 065 | Dosage: ROUTE OF ADMINISTRATION: OTHER | Form: Tablet | Indication: Rheumatoid arthritis | Action: Unknown
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 5.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
TOFACITINIB CITRATE (TOFACITINIB CITRATE) Suspect
Route: 065 | Dosage: ROUTE OF ADMINISTRATION: OTHER | Form: Tablet | Indication: Rheumatoid arthritis | Action: Unknown
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 5.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
TOFACITINIB CITRATE (TOFACITINIB CITRATE) Suspect
Route: 065 | Dosage: ROUTE OF ADMINISTRATION: OTHER | Form: Tablet | Indication: Rheumatoid arthritis | Action: Unknown
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 5.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 wk | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
VITAMIN C (ASCORBIC ACID) Suspect
Route: 065 | Dosage: DOSE FORM: NOT SPECIFIED | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
SULFASALAZINE (SULFASALAZINE) Suspect
Route: 065 | Dosage: DOSE FORM: NOT SPECIFIED, ROUTE OF ADMINISTRATION: OTHER | Form: -- | Indication: Rheumatoid arthritis | Action: Unknown
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
SULFASALAZINE (SULFASALAZINE) Suspect
Route: 065 | Dosage: DOSE FORM: NOT SPECIFIED, ROUTE OF ADMINISTRATION: OTHER | Form: -- | Indication: Rheumatoid arthritis | Action: Unknown
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 2.0 (unit: 002) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
SULFASALAZINE (SULFASALAZINE) Suspect
Route: 065 | Dosage: -- | Form: -- | Indication: Rheumatoid arthritis | Action: Unknown
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 365.0 (unit: 032) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
SIMPONI (GOLIMUMAB) Suspect
Route: 065 | Dosage: DOSE FORM: SOLUTION SUBCUTANEOUS, ROUTE OF ADMINISTRATION: OTHER | Form: -- | Indication: Rheumatoid arthritis | Action: Unknown
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 50.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
SIMPONI (GOLIMUMAB) Suspect
Route: 065 | Dosage: ROUTE OF ADMINISTRATION: OTHER | Form: Solution for injection | Indication: Rheumatoid arthritis | Action: Unknown
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
SIMPONI (GOLIMUMAB) Suspect
Route: 065 | Dosage: ROUTE OF ADMINISTRATION: OTHER | Form: Solution for injection | Indication: Rheumatoid arthritis | Action: Unknown
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
SIMPONI (GOLIMUMAB) Suspect
Route: 065 | Dosage: -- | Form: Solution for injection | Indication: Rheumatoid arthritis | Action: Unknown
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
DIETARY SUPPLEMENT\HERBALS (DIETARY SUPPLEMENT\HERBALS) Suspect
Route: 065 | Dosage: -- | Form: Oral drops | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
PREGABALIN (PREGABALIN) Suspect
Route: 065 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
LEFLUNOMIDE (LEFLUNOMIDE) Suspect
Route: 065 | Dosage: ROUTE OF ADMINISTRATION: OTHER | Form: Film-coated tablet | Indication: Rheumatoid arthritis | Action: Unknown
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 20.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
LEFLUNOMIDE (LEFLUNOMIDE) Suspect
Route: 065 | Dosage: ROUTE OF ADMINISTRATION: OTHER | Form: Film-coated tablet | Indication: Rheumatoid arthritis | Action: Unknown
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
LEFLUNOMIDE (LEFLUNOMIDE) Suspect
Route: 065 | Dosage: -- | Form: Tablet | Indication: Rheumatoid arthritis | Action: Unknown
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
MOXIFLOXACIN HYDROCHLORIDE (MOXIFLOXACIN HYDROCHLORIDE) Suspect
Route: 065 | Dosage: ROUTE OF ADMINISTRATION: OTHER | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: 077437 | Batch#: UNKNOWN | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
MYCOPHENOLATE MOFETIL (MYCOPHENOLATE MOFETIL) Suspect
Route: 065 | Dosage: -- | Form: Capsule | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
XELJANZ (TOFACITINIB CITRATE) Suspect
Route: 065 | Dosage: DOSE FORM: NOT SPECIFIED | Form: -- | Indication: Rheumatoid arthritis | Action: Unknown
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 10.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
XELJANZ (TOFACITINIB CITRATE) Suspect
Route: 065 | Dosage: -- | Form: Tablet | Indication: Rheumatoid arthritis | Action: Unknown
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 10.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
XELJANZ (TOFACITINIB CITRATE) Suspect
Route: 065 | Dosage: -- | Form: Tablet | Indication: Rheumatoid arthritis | Action: Unknown
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 10.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
XELJANZ (TOFACITINIB CITRATE) Suspect
Route: 065 | Dosage: -- | Form: Tablet | Indication: Rheumatoid arthritis | Action: Unknown
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 5.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
XELJANZ (TOFACITINIB CITRATE) Suspect
Route: 065 | Dosage: -- | Form: Tablet | Indication: Rheumatoid arthritis | Action: Unknown
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 10.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
XELJANZ (TOFACITINIB CITRATE) Suspect
Route: 065 | Dosage: -- | Form: Tablet | Indication: Rheumatoid arthritis | Action: Unknown
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 10.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
XELJANZ (TOFACITINIB CITRATE) Suspect
Route: 065 | Dosage: -- | Form: Tablet | Indication: Rheumatoid arthritis | Action: Unknown
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 10.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
RITUXIMAB (RITUXIMAB) Suspect
Route: 065 | Dosage: ROUTE OF ADMINISTRATION: OTHER | Form: -- | Indication: Rheumatoid arthritis | Action: Unknown
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
RITUXIMAB (RITUXIMAB) Suspect
Route: 065 | Dosage: ROUTE OF ADMINISTRATION: OTHER | Form: Solution for infusion | Indication: Rheumatoid arthritis | Action: Unknown
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 40.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
RITUXIMAB (RITUXIMAB) Suspect
Route: 065 | Dosage: ROUTE OF ADMINISTRATION: OTHER | Form: Solution for infusion | Indication: Rheumatoid arthritis | Action: Unknown
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 3011.2 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
RITUXIMAB (RITUXIMAB) Suspect
Route: 065 | Dosage: ROUTE OF ADMINISTRATION: OTHER | Form: Solution for infusion | Indication: Rheumatoid arthritis | Action: Unknown
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 40.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
RITUXIMAB (RITUXIMAB) Suspect
Route: 065 | Dosage: -- | Form: Solution for infusion | Indication: Rheumatoid arthritis | Action: Unknown
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 365.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
RITUXIMAB (RITUXIMAB) Suspect
Route: 065 | Dosage: -- | Form: Solution for infusion | Indication: Rheumatoid arthritis | Action: Unknown
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 40.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
RITUXIMAB (RITUXIMAB) Suspect
Route: 065 | Dosage: ROUTE OF ADMINISTRATION: OTHER | Form: Concentrate for solution for infusion | Indication: Rheumatoid arthritis | Action: Unknown
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 365.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
RITUXIMAB (RITUXIMAB) Suspect
Route: 065 | Dosage: ROUTE OF ADMINISTRATION: OTHER | Form: Concentrate for solution for infusion | Indication: Rheumatoid arthritis | Action: Unknown
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 365.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
RITUXIMAB (RITUXIMAB) Suspect
Route: 065 | Dosage: ROUTE OF ADMINISTRATION: OTHER | Form: Concentrate for solution for infusion | Indication: Rheumatoid arthritis | Action: Unknown
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
RITUXIMAB (RITUXIMAB) Suspect
Route: 065 | Dosage: ROUTE OF ADMINISTRATION: OTHER | Form: Concentrate for solution for infusion | Indication: Rheumatoid arthritis | Action: Unknown
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
SULFAMETHOXAZOLE\TRIMETHOPRIM (SULFAMETHOXAZOLE\TRIMETHOPRIM) Suspect
Route: 065 | Dosage: ROUTE OF ADMINISTRATION: OTHER | Form: Gastro-resistant tablet | Indication: Rheumatoid arthritis | Action: Unknown
Auth#: 073303 | Batch#: UNKNOWN | Structured Dosage: 1.0 (unit: 002) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
SULFAMETHOXAZOLE\TRIMETHOPRIM (SULFAMETHOXAZOLE\TRIMETHOPRIM) Suspect
Route: 065 | Dosage: -- | Form: Gastro-resistant tablet | Indication: Rheumatoid arthritis | Action: Unknown
Auth#: 073303 | Batch#: UNKNOWN | Structured Dosage: 365.0 (unit: 032) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
SULFAMETHOXAZOLE\TRIMETHOPRIM (SULFAMETHOXAZOLE\TRIMETHOPRIM) Suspect
Route: 065 | Dosage: -- | Form: Gastro-resistant tablet | Indication: Rheumatoid arthritis | Action: Unknown
Auth#: 073303 | Batch#: UNKNOWN | Structured Dosage: 2000.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
SULFAMETHOXAZOLE\TRIMETHOPRIM (SULFAMETHOXAZOLE\TRIMETHOPRIM) Suspect
Route: 065 | Dosage: -- | Form: Gastro-resistant tablet | Indication: Rheumatoid arthritis | Action: Unknown
Auth#: 073303 | Batch#: UNKNOWN | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
SULFAMETHOXAZOLE\TRIMETHOPRIM (SULFAMETHOXAZOLE\TRIMETHOPRIM) Suspect
Route: 065 | Dosage: -- | Form: Gastro-resistant tablet | Indication: Rheumatoid arthritis | Action: Unknown
Auth#: 073303 | Batch#: UNKNOWN | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
SULFAMETHOXAZOLE\TRIMETHOPRIM (SULFAMETHOXAZOLE\TRIMETHOPRIM) Suspect
Route: 065 | Dosage: -- | Form: Gastro-resistant tablet | Indication: Rheumatoid arthritis | Action: Unknown
Auth#: 073303 | Batch#: UNKNOWN | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
SULFAMETHOXAZOLE\TRIMETHOPRIM (SULFAMETHOXAZOLE\TRIMETHOPRIM) Suspect
Route: 065 | Dosage: ROUTE OF ADMINISTRATION: OTHER | Form: Gastro-resistant tablet | Indication: Rheumatoid arthritis | Action: Unknown
Auth#: 073303 | Batch#: UNKNOWN | Structured Dosage: 1.0 (unit: 002) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
SULFAMETHOXAZOLE\TRIMETHOPRIM (SULFAMETHOXAZOLE\TRIMETHOPRIM) Suspect
Route: 065 | Dosage: ROUTE OF ADMINISTRATION: OTHER | Form: Gastro-resistant tablet | Indication: Rheumatoid arthritis | Action: Unknown
Auth#: 073303 | Batch#: UNKNOWN | Structured Dosage: 2.0 (unit: 002) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
SULFAMETHOXAZOLE\TRIMETHOPRIM (SULFAMETHOXAZOLE\TRIMETHOPRIM) Suspect
Route: 065 | Dosage: ROUTE OF ADMINISTRATION: OTHER | Form: Gastro-resistant tablet | Indication: Rheumatoid arthritis | Action: Unknown
Auth#: 073303 | Batch#: UNKNOWN | Structured Dosage: 2000.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
SULFAMETHOXAZOLE\TRIMETHOPRIM (SULFAMETHOXAZOLE\TRIMETHOPRIM) Suspect
Route: 065 | Dosage: -- | Form: Gastro-resistant tablet | Indication: Rheumatoid arthritis | Action: Unknown
Auth#: 073303 | Batch#: UNKNOWN | Structured Dosage: 2000.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 1.0 yr | Rechallenge: -- | Additional: Unknown
Recurrences: --
SULFAMETHOXAZOLE\TRIMETHOPRIM (SULFAMETHOXAZOLE\TRIMETHOPRIM) Suspect
Route: 065 | Dosage: ROUTE OF ADMINISTRATION: OTHER | Form: Gastro-resistant tablet | Indication: Rheumatoid arthritis | Action: Unknown
Auth#: 073303 | Batch#: UNKNOWN | Structured Dosage: 2000.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
SULFAMETHOXAZOLE\TRIMETHOPRIM (SULFAMETHOXAZOLE\TRIMETHOPRIM) Suspect
Route: 065 | Dosage: ROUTE OF ADMINISTRATION: OTHER | Form: Gastro-resistant tablet | Indication: Rheumatoid arthritis | Action: Unknown
Auth#: 073303 | Batch#: UNKNOWN | Structured Dosage: 400.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
SULFAMETHOXAZOLE\TRIMETHOPRIM (SULFAMETHOXAZOLE\TRIMETHOPRIM) Suspect
Route: 065 | Dosage: ROUTE OF ADMINISTRATION: OTHER | Form: Gastro-resistant tablet | Indication: Rheumatoid arthritis | Action: Unknown
Auth#: 073303 | Batch#: UNKNOWN | Structured Dosage: 1.0 (unit: 032) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
SULFAMETHOXAZOLE\TRIMETHOPRIM (SULFAMETHOXAZOLE\TRIMETHOPRIM) Suspect
Route: 065 | Dosage: ROUTE OF ADMINISTRATION: OTHER | Form: Gastro-resistant tablet | Indication: Rheumatoid arthritis | Action: Unknown
Auth#: 073303 | Batch#: UNKNOWN | Structured Dosage: 4000.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 1.0 yr | Rechallenge: -- | Additional: Unknown
Recurrences: --
SULFAMETHOXAZOLE\TRIMETHOPRIM (SULFAMETHOXAZOLE\TRIMETHOPRIM) Suspect
Route: 065 | Dosage: ROUTE OF ADMINISTRATION: OTHER | Form: Gastro-resistant tablet | Indication: Rheumatoid arthritis | Action: Unknown
Auth#: 073303 | Batch#: UNKNOWN | Structured Dosage: 2000.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
SULFAMETHOXAZOLE\TRIMETHOPRIM (SULFAMETHOXAZOLE\TRIMETHOPRIM) Suspect
Route: 065 | Dosage: ROUTE OF ADMINISTRATION: OTHER | Form: Gastro-resistant tablet | Indication: Rheumatoid arthritis | Action: Unknown
Auth#: 073303 | Batch#: UNKNOWN | Structured Dosage: 2000.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
SULFAMETHOXAZOLE\TRIMETHOPRIM (SULFAMETHOXAZOLE\TRIMETHOPRIM) Suspect
Route: 065 | Dosage: ROUTE OF ADMINISTRATION: OTHER | Form: Gastro-resistant tablet | Indication: Rheumatoid arthritis | Action: Unknown
Auth#: 073303 | Batch#: UNKNOWN | Structured Dosage: 1000.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
SULFAMETHOXAZOLE\TRIMETHOPRIM (SULFAMETHOXAZOLE\TRIMETHOPRIM) Suspect
Route: 065 | Dosage: ROUTE OF ADMINISTRATION: OTHER | Form: Gastro-resistant tablet | Indication: Rheumatoid arthritis | Action: Unknown
Auth#: 073303 | Batch#: UNKNOWN | Structured Dosage: 2.0 (unit: 002) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
SULFAMETHOXAZOLE\TRIMETHOPRIM (SULFAMETHOXAZOLE\TRIMETHOPRIM) Suspect
Route: 065 | Dosage: -- | Form: Gastro-resistant tablet | Indication: Rheumatoid arthritis | Action: Unknown
Auth#: 073303 | Batch#: UNKNOWN | Structured Dosage: 2.0 (unit: 002) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
SULFAMETHOXAZOLE\TRIMETHOPRIM (SULFAMETHOXAZOLE\TRIMETHOPRIM) Suspect
Route: 065 | Dosage: -- | Form: Gastro-resistant tablet | Indication: Rheumatoid arthritis | Action: Unknown
Auth#: 073303 | Batch#: UNKNOWN | Structured Dosage: 1.0 (unit: 002) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
SULFAMETHOXAZOLE\TRIMETHOPRIM (SULFAMETHOXAZOLE\TRIMETHOPRIM) Suspect
Route: 065 | Dosage: -- | Form: -- | Indication: Rheumatoid arthritis | Action: Unknown
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 500.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
SULFAMETHOXAZOLE\TRIMETHOPRIM (SULFAMETHOXAZOLE\TRIMETHOPRIM) Suspect
Route: 065 | Dosage: -- | Form: Gastro-resistant tablet | Indication: Rheumatoid arthritis | Action: Unknown
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 500.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
SULFAMETHOXAZOLE\TRIMETHOPRIM (SULFAMETHOXAZOLE\TRIMETHOPRIM) Suspect
Route: 065 | Dosage: -- | Form: Gastro-resistant tablet | Indication: Rheumatoid arthritis | Action: Unknown
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 500.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 1.0 yr | Rechallenge: -- | Additional: Unknown
Recurrences: --
SULFAMETHOXAZOLE\TRIMETHOPRIM (SULFAMETHOXAZOLE\TRIMETHOPRIM) Suspect
Route: 065 | Dosage: -- | Form: Gastro-resistant tablet | Indication: Rheumatoid arthritis | Action: Unknown
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 500.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
SULFAMETHOXAZOLE\TRIMETHOPRIM (SULFAMETHOXAZOLE\TRIMETHOPRIM) Suspect
Route: 065 | Dosage: ROUTE OF ADMINISTRATION: OTHER | Form: Gastro-resistant tablet | Indication: Rheumatoid arthritis | Action: Unknown
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 100.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
DILTIAZEM (DILTIAZEM) Suspect
Route: 065 | Dosage: -- | Form: Solution for injection | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
DILTIAZEM (DILTIAZEM) Suspect
Route: 065 | Dosage: -- | Form: Solution for injection | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
DILTIAZEM (DILTIAZEM) Suspect
Route: 065 | Dosage: -- | Form: Solution for injection | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --

Clinical Narrative

--

Report Duplicates (2)

Health Canada: E2B_08129184
Market Authorization Holder AER Number: 2247437

Raw JSON (click to expand)

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null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Solution 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": "DILTIAZEM" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "DILTIAZEM", "drugauthorizationnumb": null, "drugbatchnumb": "UNKNOWN", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, 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"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": "DILTIAZEM" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "CA", "qualification": 3, "literaturereference": null }, "primarysourcecountry": "CA", "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": "Health Canada", "duplicatenumb": "E2B_08129184" }, { "duplicatesource": "Market Authorization Holder AER Number", "duplicatenumb": "2247437" } ], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "TEVA" }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 1, "seriousnessdisabling": 1, "seriousnesshospitalization": 1, "seriousnesslifethreatening": 1, "seriousnessother": 1, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-17T00:00:00", "transmissiondateformat": "102" }
25963535 Type 1
Non-Serious
VRAYLAR
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-ABBVIE-6513138
Authority Number
--
Sender Organization
ABBVIE
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
No
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
--
Patient Age Group
Adult
Patient Sex
Female
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Blood triglycerides increased (v28.1) Recovering
Haemoglobin increased (v28.1) Recovering

Drugs (1)

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

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435bd3b3830196fa58290", "safetyreportid": "25963535", "authoritynumb": null, "companynumb": "US-ABBVIE-6513138", "duplicate": null, "fulfillexpeditecriteria": 2, "occurcountry": "US", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": 5, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Blood triglycerides increased", "reactionoutcome": 2 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Haemoglobin increased", "reactionoutcome": 2 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "VRAYLAR", "drugauthorizationnumb": "204370", "drugbatchnumb": null, "drugstructuredosagenumb": 1.5, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": "048", "drugindication": "Depression", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "CARIPRAZINE" }, "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": "ABBVIE" }, "serious": 2, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-17T00:00:00", "transmissiondateformat": "102" }
25963533 Type 1
Non-Serious
JOURNAVX
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-VERTEX PHARMACEUTICALS-2025-017548
Authority Number
--
Sender Organization
VERTEX
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)

Rash (v28.1) Recovered

Drugs (1)

JOURNAVX (SUZETRIGINE) Suspect
Route: 048 | Dosage: UNK | Form: Film-coated tablet | Indication: Product used for unknown indication | Action: Unknown
Auth#: 219209 | Batch#: -- | 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": "69d435bd3b3830196fa5828e", "safetyreportid": "25963533", "authoritynumb": null, "companynumb": "US-VERTEX PHARMACEUTICALS-2025-017548", "duplicate": null, "fulfillexpeditecriteria": 2, "occurcountry": "US", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": null, "patientsex": null, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Rash", "reactionoutcome": 1 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "JOURNAVX", "drugauthorizationnumb": "219209", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": "Film-coated tablet", "drugadministrationroute": "048", "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": "SUZETRIGINE" }, "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": "VERTEX" }, "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" }
25963531 Type 1
Serious
ELEXACAFTOR\IVACAFTOR\TEZACAFTOR, KALYDECO
Report Version
1
Receive Date
10/27/2025
Receipt Date
10/27/2025
Transmission Date
01/17/2026
Primary Source Country
GB
Occurrence Country
GB
Reporter Country
GB
Reporter Qualification
Consumer
Literature Reference
--
Company Number
GB-VERTEX PHARMACEUTICALS-2025-017820
Authority Number
--
Sender Organization
VERTEX
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
Adolescent
Patient Sex
Female
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Hospitalisation (v28.1) Unknown

Drugs (2)

ELEXACAFTOR\IVACAFTOR\TEZACAFTOR (ELEXACAFTOR\IVACAFTOR\TEZACAFTOR) Suspect
Route: 048 | Dosage: 2 TABLETS (75MG IVACAFTOR/50MG TEZACAFTOR/100MG ELEXACAFTOR) IN MORNING | Form: Film-coated tablet | Indication: Cystic fibrosis | Action: Unknown
Auth#: 212273 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Unknown
Recurrences: --
KALYDECO (IVACAFTOR) Suspect
Route: 048 | Dosage: UNKNOWN DOSAGE REGIMEN | Form: Film-coated tablet | Indication: Cystic fibrosis | Action: Unknown
Auth#: 203188 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Unknown
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250101

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435bd3b3830196fa5828c", "safetyreportid": "25963531", "authoritynumb": null, "companynumb": "GB-VERTEX PHARMACEUTICALS-2025-017820", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "GB", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": 4, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Hospitalisation", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "ELEXACAFTOR\\IVACAFTOR\\TEZACAFTOR", "drugauthorizationnumb": "212273", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "2 TABLETS (75MG IVACAFTOR/50MG TEZACAFTOR/100MG ELEXACAFTOR) IN MORNING", "drugdosageform": "Film-coated tablet", "drugadministrationroute": "048", "drugindication": "Cystic fibrosis", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "ELEXACAFTOR\\IVACAFTOR\\TEZACAFTOR" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "KALYDECO", "drugauthorizationnumb": "203188", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNKNOWN DOSAGE REGIMEN", "drugdosageform": "Film-coated tablet", "drugadministrationroute": "048", "drugindication": "Cystic fibrosis", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "IVACAFTOR" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250101" }, "primarysource": { "reportercountry": "GB", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "GB", "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": "VERTEX" }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 1, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-17T00:00:00", "transmissiondateformat": "102" }
25963530 Type 1
Serious
ELEXACAFTOR\IVACAFTOR\TEZACAFTOR, KALYDECO
Report Version
1
Receive Date
10/27/2025
Receipt Date
10/27/2025
Transmission Date
01/18/2026
Primary Source Country
GB
Occurrence Country
GB
Reporter Country
GB
Reporter Qualification
Consumer
Literature Reference
--
Company Number
GB-VERTEX PHARMACEUTICALS-2025-017764
Authority Number
--
Sender Organization
VERTEX
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
Adult
Patient Sex
Male
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Infective pulmonary exacerbation of cystic fibrosis (v28.1) Unknown

Drugs (2)

ELEXACAFTOR\IVACAFTOR\TEZACAFTOR (ELEXACAFTOR\IVACAFTOR\TEZACAFTOR) Suspect
Route: 048 | Dosage: 2 TABS IN AM (75 MG IVA/ 50 MG TEZA/ 100 MG ELEXA) | Form: Film-coated tablet | Indication: Cystic fibrosis | Action: Unknown
Auth#: 212273 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Unknown
Recurrences: --
KALYDECO (IVACAFTOR) Suspect
Route: 048 | Dosage: UNK | Form: Film-coated tablet | Indication: Cystic fibrosis | Action: Unknown
Auth#: 203188 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Unknown
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250101

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435bd3b3830196fa5828a", "safetyreportid": "25963530", "authoritynumb": null, "companynumb": "GB-VERTEX PHARMACEUTICALS-2025-017764", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "GB", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": 5, "patientweight": null, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Infective pulmonary exacerbation of cystic fibrosis", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "ELEXACAFTOR\\IVACAFTOR\\TEZACAFTOR", "drugauthorizationnumb": "212273", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "2 TABS IN AM (75 MG IVA/ 50 MG TEZA/ 100 MG ELEXA)", "drugdosageform": "Film-coated tablet", "drugadministrationroute": "048", "drugindication": "Cystic fibrosis", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "ELEXACAFTOR\\IVACAFTOR\\TEZACAFTOR" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "KALYDECO", "drugauthorizationnumb": "203188", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": "Film-coated tablet", "drugadministrationroute": "048", "drugindication": "Cystic fibrosis", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "IVACAFTOR" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250101" }, "primarysource": { "reportercountry": "GB", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "GB", "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": "VERTEX" }, "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" }
25963528 Type 1
Non-Serious
SUZETRIGINE, PERCOCET, TRAMADOL
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-VERTEX PHARMACEUTICALS-2025-017328
Authority Number
--
Sender Organization
VERTEX
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 (5)

Nausea (v28.1) Not Recovered
Headache (v28.1) Not Recovered
Somnolence (v28.1) Not Recovered
Vomiting (v28.1) Recovered
Brain fog (v28.1) Not Recovered

Drugs (3)

SUZETRIGINE (SUZETRIGINE) Suspect
Route: 048 | Dosage: 50 MG, BID | Form: Film-coated tablet | Indication: Pain | Action: Unknown
Auth#: 219209 | Batch#: -- | Structured Dosage: 50.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 12.0 hr | Cumulative: 1400.0 (unit: 003)
Start: 09/30/2025 | End: 10/14/2025 | Duration: 15.0 day | Rechallenge: Unknown | Additional: Unknown
Recurrences: --
PERCOCET (ACETAMINOPHEN\OXYCODONE HYDROCHLORIDE) Concomitant
Route: -- | Dosage: UNK | Form: -- | Indication: Knee arthroplasty | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
TRAMADOL (TRAMADOL) Concomitant
Route: -- | Dosage: UNK | Form: -- | Indication: Knee arthroplasty | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250101

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435bd3b3830196fa58289", "safetyreportid": "25963528", "authoritynumb": null, "companynumb": "US-VERTEX PHARMACEUTICALS-2025-017328", "duplicate": null, "fulfillexpeditecriteria": 2, "occurcountry": "US", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": null, "patientsex": null, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Nausea", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Headache", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Somnolence", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Vomiting", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Brain fog", "reactionoutcome": 3 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "SUZETRIGINE", "drugauthorizationnumb": "219209", "drugbatchnumb": null, "drugstructuredosagenumb": 50.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 12.0, "drugintervaldosagedefinition": 805, "drugcumulativedosagenumb": 1400.0, "drugcumulativedosageunit": "003", "drugdosagetext": "50 MG, BID", "drugdosageform": "Film-coated tablet", "drugadministrationroute": "048", "drugindication": "Pain", "drugstartdateformat": "102", "drugstartdate": "2025-09-30T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-10-14T00:00:00", "drugtreatmentduration": 15.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "SUZETRIGINE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "PERCOCET", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Knee arthroplasty", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "ACETAMINOPHEN\\OXYCODONE HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "TRAMADOL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Knee arthroplasty", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "TRAMADOL" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250101" }, "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": "VERTEX" }, "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" }
25963525 Type 1
Serious
ELEXACAFTOR\IVACAFTOR\TEZACAFTOR, KALYDECO
Report Version
1
Receive Date
10/27/2025
Receipt Date
10/27/2025
Transmission Date
01/18/2026
Primary Source Country
GB
Occurrence Country
GB
Reporter Country
GB
Reporter Qualification
Consumer
Literature Reference
--
Company Number
GB-VERTEX PHARMACEUTICALS-2025-017778
Authority Number
--
Sender Organization
VERTEX
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
Adult
Patient Sex
Female
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Lower respiratory tract infection (v28.1) Unknown

Drugs (2)

ELEXACAFTOR\IVACAFTOR\TEZACAFTOR (ELEXACAFTOR\IVACAFTOR\TEZACAFTOR) Suspect
Route: 048 | Dosage: 75MG IVA/50MG TEZA/100MG ELEXA, 2 TABS IN AM | Form: Film-coated tablet | Indication: Cystic fibrosis | Action: Withdrawn
Auth#: 212273 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: --
Recurrences: --
KALYDECO (IVACAFTOR) Suspect
Route: 048 | Dosage: UNK | Form: Film-coated tablet | Indication: Cystic fibrosis | Action: Withdrawn
Auth#: 203188 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: --
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250101

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435bd3b3830196fa58288", "safetyreportid": "25963525", "authoritynumb": null, "companynumb": "GB-VERTEX PHARMACEUTICALS-2025-017778", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "GB", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": 5, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Lower respiratory tract infection", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "ELEXACAFTOR\\IVACAFTOR\\TEZACAFTOR", "drugauthorizationnumb": "212273", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "75MG IVA/50MG TEZA/100MG ELEXA, 2 TABS IN AM", "drugdosageform": "Film-coated tablet", "drugadministrationroute": "048", "drugindication": "Cystic fibrosis", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": null, "actiondrug": 1, "activesubstance": { "activesubstancename": "ELEXACAFTOR\\IVACAFTOR\\TEZACAFTOR" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "KALYDECO", "drugauthorizationnumb": "203188", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": "Film-coated tablet", "drugadministrationroute": "048", "drugindication": "Cystic fibrosis", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": null, "actiondrug": 1, "activesubstance": { "activesubstancename": "IVACAFTOR" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250101" }, "primarysource": { "reportercountry": "GB", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "GB", "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": "VERTEX" }, "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" }