Person who experienced the adverse event (patient)
| Event ID | CASEID | CASEVERSION | I F COD | EVENT DT | MFR DT | INIT FDA DT | FDA DT | REPT COD | AUTH NUM | MFR NUM | MFR SNDR | LIT REF | AGE | AGE COD | AGE GRP | GNDR COD | E SUB | WT | WT COD | REPT DT | TO MFR | OCCP COD | REPORTER COUNTRY | OCCR COUNTRY |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122183615 | 12218361 | 5 | F | 20160621 | 20160329 | 20160704 | EXP | US-APOTEX-2016AP007302 | APOTEX | 0.00 | F | Y | 72.57000 | KG | 20160704 | CN | US | US |
Drug(s) used by person
| Event ID | CASEID | DRUG SEQ | ROLE COD | DRUGNAME | PROD AI | VAL VBM | ROUTE | DOSE VBM | CUM DOSE CHR | CUM DOSE UNIT | DECHAL | RECHAL | LOT NUM | EXP DT | NDA NUM | DOSE AMT | DOSE UNIT | DOSE FORM | DOSE FREQ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122183615 | 12218361 | 1 | PS | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | Unknown | 75 MG, QD | 20031 | 75 | MG | TABLET | |||||||
| 122183615 | 12218361 | 2 | SS | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | Unknown | 50 MG, QD | 20031 | 50 | MG | TABLET | |||||||
| 122183615 | 12218361 | 3 | SS | GABAPENTIN PFIZER | GABAPENTIN | 1 | Oral | 2 OR 3 DF, UNKNOWN | Y | 1146374 | 0 | ||||||||
| 122183615 | 12218361 | 4 | SS | GABAPENTIN PFIZER | GABAPENTIN | 1 | Y | 0 | |||||||||||
| 122183615 | 12218361 | 5 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | Unknown | 40 MG, Q.AM | 0 | 40 | MG | QD | |||||||
| 122183615 | 12218361 | 6 | C | TRAZODONE | TRAZODONE HYDROCHLORIDE | 1 | Unknown | 100 MG, Q.H.S. | 0 | 100 | MG | QD | |||||||
| 122183615 | 12218361 | 7 | C | CLONAZEPAM. | CLONAZEPAM | 1 | Unknown | 0.5, TWO TIMES A DAY | 0 | 2 | DF |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 122183615 | 12218361 | 1 | Depression |
| 122183615 | 12218361 | 2 | Anxiety |
| 122183615 | 12218361 | 3 | Fibromyalgia |
| 122183615 | 12218361 | 4 | Pain |
| 122183615 | 12218361 | 5 | Product used for unknown indication |
| 122183615 | 12218361 | 6 | Sleep disorder |
| 122183615 | 12218361 | 7 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 122183615 | 12218361 | DS |
| 122183615 | 12218361 | HO |
| 122183615 | 12218361 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 122183615 | 12218361 | Abasia | |
| 122183615 | 12218361 | Anxiety | |
| 122183615 | 12218361 | Asthenia | |
| 122183615 | 12218361 | Back pain | |
| 122183615 | 12218361 | Depression | |
| 122183615 | 12218361 | Dizziness | |
| 122183615 | 12218361 | Drug ineffective | |
| 122183615 | 12218361 | Drug interaction | |
| 122183615 | 12218361 | Fatigue | |
| 122183615 | 12218361 | Restlessness |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|---|
| 122183615 | 12218361 | 3 | 20160304 | 20160308 | 0 |