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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125388321 | 12538832 | 1 | I | 20160127 | 20160629 | 20160708 | 20160708 | EXP | US-DRREDDYS-USA/USA/16/0081144 | DR REDDYS | 59.47 | YR | F | Y | 54.80000 | KG | 20160708 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125388321 | 12538832 | 1 | PS | AUGMENTIN | AMOXICILLINCLAVULANATE POTASSIUM | 1 | Oral | Y | UNKNOWN | 50720 | 875 | MG | TABLET | BID | |||||
| 125388321 | 12538832 | 2 | SS | FLAGYL | METRONIDAZOLEMETRONIDAZOLE HYDROCHLORIDE | 1 | Unknown | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125388321 | 12538832 | 1 | Sinusitis |
| 125388321 | 12538832 | 2 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125388321 | 12538832 | OT |
| 125388321 | 12538832 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125388321 | 12538832 | Anorectal discomfort | |
| 125388321 | 12538832 | Anxiety | |
| 125388321 | 12538832 | Asthenia | |
| 125388321 | 12538832 | Clostridium difficile infection | |
| 125388321 | 12538832 | Dehydration | |
| 125388321 | 12538832 | Eating disorder | |
| 125388321 | 12538832 | Fatigue | |
| 125388321 | 12538832 | Gait disturbance | |
| 125388321 | 12538832 | Headache | |
| 125388321 | 12538832 | Insomnia | |
| 125388321 | 12538832 | Pain in extremity | |
| 125388321 | 12538832 | Peripheral swelling | |
| 125388321 | 12538832 | Proctalgia | |
| 125388321 | 12538832 | Pyrexia | |
| 125388321 | 12538832 | Rectal haemorrhage | |
| 125388321 | 12538832 | Rectal prolapse | |
| 125388321 | 12538832 | Weight decreased | |
| 125388321 | 12538832 | Weight increased |
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 |
|---|---|---|---|---|---|---|
| 125388321 | 12538832 | 1 | 20160121 | 20160126 | 0 |