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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123202412 | 12320241 | 2 | F | 20160421 | 20160429 | 20160720 | EXP | IT-MYLANLABS-2016M1017342 | MYLAN | MELIS M, CUPELLI A, SOTTOSANTI L, BUCCELLATO E, BIAGI C, VACCHERI A, ET AL. OFF-LABEL USE OF NICARDIPINE AS TOCOLYTIC AND ACUTE PULMONARY OEDEMA: A POST-MARKETING ANALYSIS OF ADVERSE DRUG REACTION REPORTS IN EUDRAVIGILANCE. PHARMACOEPIDEMIOL-DRUG-SAF 2015;24(11):1220-1224. | 0.00 | Y | 0.00000 | 20160720 | OT | IT | IT |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123202412 | 12320241 | 1 | PS | NICARDIPINE | NICARDIPINE | 1 | Intravenous (not otherwise specified) | DAILY DOSE OF 2 MG/HOUR | Y | U | 90664 | INJECTION | |||||||
| 123202412 | 12320241 | 2 | SS | BETAMETHASONE. | BETAMETHASONE | 1 | Unknown | U | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123202412 | 12320241 | 1 | Premature labour |
| 123202412 | 12320241 | 2 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123202412 | 12320241 | LT |
| 123202412 | 12320241 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123202412 | 12320241 | Acute pulmonary oedema | |
| 123202412 | 12320241 | Maternal exposure during pregnancy | |
| 123202412 | 12320241 | Off label use |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |