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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127787451 | 12778745 | 1 | I | 20150921 | 20160726 | 20160926 | 20160926 | PER | US-AUROBINDO-AUR-APU-2016-09847 | AUROBINDO | 47.04 | YR | F | Y | 0.00000 | 20160926 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127787451 | 12778745 | 1 | PS | MONTELUKAST | MONTELUKAST SODIUM | 1 | Unknown | UNK | U | 202096 | |||||||||
| 127787451 | 12778745 | 2 | SS | VENLAFAXINE | VENLAFAXINE HYDROCHLORIDE | 1 | Oral | 75 MG, TWO TIMES A DAY | U | 0 | 75 | MG | BID | ||||||
| 127787451 | 12778745 | 3 | C | LEVOCETIRIZINE | LEVOCETIRIZINE | 1 | Unknown | U | 0 | ||||||||||
| 127787451 | 12778745 | 4 | C | LAMOTRIGINE. | LAMOTRIGINE | 1 | Unknown | 200 MG, UNK | U | 0 | 200 | MG | |||||||
| 127787451 | 12778745 | 5 | C | LEVOTHYROXINE. | LEVOTHYROXINE | 1 | Unknown | 125 MCG, UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127787451 | 12778745 | 1 | Seasonal allergy |
| 127787451 | 12778745 | 2 | Bipolar disorder |
| 127787451 | 12778745 | 3 | Seasonal allergy |
| 127787451 | 12778745 | 4 | Affective disorder |
| 127787451 | 12778745 | 5 | Thyroidectomy |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127787451 | 12778745 | Diarrhoea | |
| 127787451 | 12778745 | Feeling abnormal | |
| 127787451 | 12778745 | Headache | |
| 127787451 | 12778745 | Muscle spasms | |
| 127787451 | 12778745 | Nausea | |
| 127787451 | 12778745 | Tremor |
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 |
|---|---|---|---|---|---|---|
| 127787451 | 12778745 | 2 | 20150921 | 0 | ||
| 127787451 | 12778745 | 4 | 201503 | 0 | ||
| 127787451 | 12778745 | 5 | 201406 | 0 |