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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124508332 | 12450833 | 2 | F | 20160628 | 20160609 | 20160712 | EXP | US-AUROBINDO-AUR-APL-2016-07687 | AUROBINDO | 33.00 | YR | F | Y | 0.00000 | 20160712 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124508332 | 12450833 | 1 | PS | QUETIAPINE. | QUETIAPINE | 1 | Unknown | UNK | Y | U | 91388 | ||||||||
| 124508332 | 12450833 | 2 | I | SERTRALINE | SERTRALINE HYDROCHLORIDE | 1 | Unknown | UNK | Y | U | 0 | ||||||||
| 124508332 | 12450833 | 3 | I | SERTRALINE | SERTRALINE HYDROCHLORIDE | 1 | Y | U | 0 | ||||||||||
| 124508332 | 12450833 | 4 | I | VENLAFAXINE | VENLAFAXINE HYDROCHLORIDE | 1 | Unknown | 150 MG, 2 TO 4 TIMES THE RECOMMENDED STARTING DOSE | Y | U | 0 | 150 | MG | ||||||
| 124508332 | 12450833 | 5 | I | VENLAFAXINE | VENLAFAXINE HYDROCHLORIDE | 1 | Unknown | 75 MG, UNK | Y | U | 0 | 75 | MG | ||||||
| 124508332 | 12450833 | 6 | I | VENLAFAXINE | VENLAFAXINE HYDROCHLORIDE | 1 | Unknown | 150 MG, SHE RESUMED HER PRESCRIBED DOSAGE | Y | U | 0 | 150 | MG | ||||||
| 124508332 | 12450833 | 7 | I | TEMAZEPAM. | TEMAZEPAM | 1 | Unknown | UNK | Y | U | 0 | ||||||||
| 124508332 | 12450833 | 8 | I | TEMAZEPAM. | TEMAZEPAM | 1 | Y | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124508332 | 12450833 | 1 | Insomnia |
| 124508332 | 12450833 | 2 | Depression |
| 124508332 | 12450833 | 3 | Anxiety |
| 124508332 | 12450833 | 4 | Product used for unknown indication |
| 124508332 | 12450833 | 7 | Anxiety |
| 124508332 | 12450833 | 8 | Depression |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124508332 | 12450833 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124508332 | 12450833 | Abnormal behaviour | |
| 124508332 | 12450833 | Aggression | |
| 124508332 | 12450833 | Akathisia | |
| 124508332 | 12450833 | Depressed mood | |
| 124508332 | 12450833 | Drug interaction | |
| 124508332 | 12450833 | Fatigue | |
| 124508332 | 12450833 | Homicidal ideation | |
| 124508332 | 12450833 | Mood swings | |
| 124508332 | 12450833 | Panic attack | |
| 124508332 | 12450833 | Suicidal ideation | |
| 124508332 | 12450833 | Toxicity to various agents | |
| 124508332 | 12450833 | Withdrawal syndrome |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |