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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125259711 | 12525971 | 1 | I | 20160621 | 20160705 | 20160705 | EXP | GB-AUROBINDO-AUR-APL-2016-08542 | AUROBINDO | 21.00 | YR | F | Y | 0.00000 | 20160705 | CN | GB | GB |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125259711 | 12525971 | 1 | PS | PAROXETINE. | PAROXETINE | 1 | Unknown | UNK | U | U | 78406 | ||||||||
| 125259711 | 12525971 | 2 | SS | SEROXAT | PAROXETINE HYDROCHLORIDE | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 125259711 | 12525971 | 3 | C | ANAFRANIL | CLOMIPRAMINE HYDROCHLORIDE | 1 | Unknown | UNK | U | 0 | |||||||||
| 125259711 | 12525971 | 4 | C | EFFEXOR | VENLAFAXINE HYDROCHLORIDE | 1 | Unknown | U | 0 | ||||||||||
| 125259711 | 12525971 | 5 | C | PARACETAMOL | ACETAMINOPHEN | 1 | Unknown | UNK | U | 0 | |||||||||
| 125259711 | 12525971 | 6 | C | QUETIAPINE. | QUETIAPINE | 1 | Unknown | U | 0 | ||||||||||
| 125259711 | 12525971 | 7 | C | SERTRALINE | SERTRALINE HYDROCHLORIDE | 1 | Unknown | UNK | U | 0 | |||||||||
| 125259711 | 12525971 | 8 | C | STILNOCT | ZOLPIDEM TARTRATE | 1 | Unknown | UNK | U | 0 | |||||||||
| 125259711 | 12525971 | 9 | C | ZIMOVANE | ZOPICLONE | 1 | Unknown | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125259711 | 12525971 | 1 | Product used for unknown indication |
| 125259711 | 12525971 | 2 | Depression |
| 125259711 | 12525971 | 3 | Product used for unknown indication |
| 125259711 | 12525971 | 4 | Depression |
| 125259711 | 12525971 | 5 | Product used for unknown indication |
| 125259711 | 12525971 | 6 | Product used for unknown indication |
| 125259711 | 12525971 | 7 | Product used for unknown indication |
| 125259711 | 12525971 | 8 | Product used for unknown indication |
| 125259711 | 12525971 | 9 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125259711 | 12525971 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125259711 | 12525971 | Affect lability | |
| 125259711 | 12525971 | Aggression | |
| 125259711 | 12525971 | Agitation | |
| 125259711 | 12525971 | Altered state of consciousness | |
| 125259711 | 12525971 | Anxiety | |
| 125259711 | 12525971 | Circulatory collapse | |
| 125259711 | 12525971 | Confusional state | |
| 125259711 | 12525971 | Delusion | |
| 125259711 | 12525971 | Disorientation | |
| 125259711 | 12525971 | Dizziness | |
| 125259711 | 12525971 | Drug withdrawal syndrome | |
| 125259711 | 12525971 | Fatigue | |
| 125259711 | 12525971 | Feeling of despair | |
| 125259711 | 12525971 | Hallucination, auditory | |
| 125259711 | 12525971 | Helplessness | |
| 125259711 | 12525971 | Hyperhidrosis | |
| 125259711 | 12525971 | Insomnia | |
| 125259711 | 12525971 | Muscle disorder | |
| 125259711 | 12525971 | Muscular weakness | |
| 125259711 | 12525971 | Nausea | |
| 125259711 | 12525971 | Nightmare | |
| 125259711 | 12525971 | Panic attack | |
| 125259711 | 12525971 | Paraesthesia | |
| 125259711 | 12525971 | Seizure | |
| 125259711 | 12525971 | Sleep disorder | |
| 125259711 | 12525971 | Somnolence | |
| 125259711 | 12525971 | Suicidal ideation | |
| 125259711 | 12525971 | Tearfulness | |
| 125259711 | 12525971 | Terminal insomnia | |
| 125259711 | 12525971 | Tremor | |
| 125259711 | 12525971 | Vertigo |
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 |
|---|---|---|---|---|---|---|
| 125259711 | 12525971 | 2 | 20001123 | 0 | ||
| 125259711 | 12525971 | 4 | 20010713 | 20021216 | 0 |