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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125204401 | 12520440 | 1 | I | 20160620 | 20160701 | 20160701 | EXP | GB-AUROBINDO-AUR-APL-2016-08251 | AUROBINDO | 85.00 | YR | Y | 0.00000 | 20160701 | PH | GB | GB |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125204401 | 12520440 | 1 | PS | Amlodipine Tablets 5mg | AMLODIPINE BESYLATE | 1 | Unknown | 5 MG, ONCE A DAY | U | 78021 | 5 | MG | TABLET | QD | |||||
| 125204401 | 12520440 | 2 | SS | ATENOLOL. | ATENOLOL | 1 | Unknown | 25 MG, ONCE A DAY | U | 0 | 25 | MG | TABLET | QD | |||||
| 125204401 | 12520440 | 3 | C | SIMVASTATIN. | SIMVASTATIN | 1 | Unknown | 20 MG, ONCE A DAY | U | 0 | 20 | MG | TABLET | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125204401 | 12520440 | 1 | Product used for unknown indication |
| 125204401 | 12520440 | 2 | Product used for unknown indication |
| 125204401 | 12520440 | 3 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125204401 | 12520440 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125204401 | 12520440 | Crepitations | |
| 125204401 | 12520440 | Loss of consciousness | |
| 125204401 | 12520440 | Nausea | |
| 125204401 | 12520440 | Orthostatic hypotension | |
| 125204401 | 12520440 | Respiratory tract infection | |
| 125204401 | 12520440 | Syncope | |
| 125204401 | 12520440 | Vomiting |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |