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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127610251 | 12761025 | 1 | I | 20160908 | 20160919 | 20160919 | EXP | US-MACLEODS PHARMACEUTICALS US LTD-MAC2016003126 | MACLEODS | 0.00 | Y | 0.00000 | 20160920 | OT | GB | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127610251 | 12761025 | 1 | PS | AMLODIPINE BESYLATE. | AMLODIPINE BESYLATE | 1 | Unknown | UNK | U | 0 | |||||||||
| 127610251 | 12761025 | 2 | SS | LABETALOL | LABETALOLLABETALOL HYDROCHLORIDE | 1 | Unknown | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127610251 | 12761025 | 1 | Product used for unknown indication |
| 127610251 | 12761025 | 2 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127610251 | 12761025 | OT |
| 127610251 | 12761025 | LT |
| 127610251 | 12761025 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127610251 | 12761025 | Bradycardia | |
| 127610251 | 12761025 | Cardiovascular disorder | |
| 127610251 | 12761025 | Dysarthria | |
| 127610251 | 12761025 | Hypotension | |
| 127610251 | 12761025 | Intentional overdose | |
| 127610251 | 12761025 | Mental status changes | |
| 127610251 | 12761025 | Toxicity to various agents |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |