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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127283501 | 12728350 | 1 | I | 20160831 | 0 | 20160907 | 20160907 | DIR | US-FDA-349991 | FDA-CTU | 91.00 | YR | F | N | 85.00000 | KG | 20160907 | N | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127283501 | 12728350 | 1 | PS | LEVOFLOXACIN. | LEVOFLOXACIN | 1 | Oral | OTHER STRENGTH:;OTHER DOSE:1 TABLET;OTHER FREQUENCY: 3 TIMES A DAY;OTHER ROUTE: ORAL | Y | Y | 0 | 1 | DF | COATED TABLET | TID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127283501 | 12728350 | 1 | Urinary tract infection |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127283501 | 12728350 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127283501 | 12728350 | Aggression | |
| 127283501 | 12728350 | Agitation | |
| 127283501 | 12728350 | Anxiety | |
| 127283501 | 12728350 | Confusional state | |
| 127283501 | 12728350 | Documented hypersensitivity to administered product | |
| 127283501 | 12728350 | Hallucination | |
| 127283501 | 12728350 | Insomnia | |
| 127283501 | 12728350 | Logorrhoea | |
| 127283501 | 12728350 | Psychotic disorder | |
| 127283501 | 12728350 | Similar reaction on previous exposure to drug |
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 |
|---|---|---|---|---|---|---|
| 127283501 | 12728350 | 1 | 20160831 | 20160902 | 0 |