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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127678332 | 12767833 | 2 | F | 2012 | 20160921 | 20160921 | 20160928 | EXP | US-MYLANLABS-2016M1039773 | MYLAN | 0.00 | Y | 0.00000 | 20160928 | PH | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127678332 | 12767833 | 1 | PS | Alprazolam Tablets, USP | ALPRAZOLAM | 1 | Oral | 1 MG, QID | 8037120 | 74215 | 1 | MG | TABLET | QID | |||||
| 127678332 | 12767833 | 2 | SS | HALDOL | HALOPERIDOL | 1 | UNK | U | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127678332 | 12767833 | 1 | Anxiety |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127678332 | 12767833 | HO |
| 127678332 | 12767833 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127678332 | 12767833 | Abdominal pain | |
| 127678332 | 12767833 | Aggression | |
| 127678332 | 12767833 | Angina unstable | |
| 127678332 | 12767833 | Diarrhoea | |
| 127678332 | 12767833 | Hypoaesthesia | |
| 127678332 | 12767833 | Joint swelling | |
| 127678332 | 12767833 | Loss of consciousness | |
| 127678332 | 12767833 | Mood swings | |
| 127678332 | 12767833 | Nausea | |
| 127678332 | 12767833 | Oral mucosal blistering | |
| 127678332 | 12767833 | Pain in extremity | |
| 127678332 | 12767833 | Peripheral swelling | |
| 127678332 | 12767833 | Transient ischaemic attack | |
| 127678332 | 12767833 | Urinary incontinence | |
| 127678332 | 12767833 | Vertigo | |
| 127678332 | 12767833 | Weight increased | |
| 127678332 | 12767833 | Withdrawal syndrome |
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 |
|---|---|---|---|---|---|---|
| 127678332 | 12767833 | 1 | 201208 | 0 |