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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125931352 | 12593135 | 2 | F | 20160810 | 20160726 | 20160812 | EXP | PT-MYLANLABS-2016M1030022 | MYLAN | SARA VIANA, TAMAR NUNEZ GARCIA, NIDIA CALADO, MARIA FRANCISCA MAGALHAES, ISABEL SOLES, VERA ESCOTO. EFEITO DESMIELINIZANTE ANTIDEPRESSIVOS. 229 CONGRESSO NACIONAL DE MEDICINA INTERNA. 419 | 0.00 | Y | 0.00000 | 20160812 | OT | PT | PT |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125931352 | 12593135 | 1 | PS | SERTRALINE | SERTRALINE HYDROCHLORIDE | 1 | UNK | Y | U | 78626 | |||||||||
| 125931352 | 12593135 | 2 | SS | METOCLOPRAMIDE. | METOCLOPRAMIDE | 1 | UNK | Y | U | 0 | |||||||||
| 125931352 | 12593135 | 3 | SS | BETAHISTINE | BETAHISTINE | 1 | UNK | Y | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125931352 | 12593135 | 1 | Product used for unknown indication |
| 125931352 | 12593135 | 2 | Product used for unknown indication |
| 125931352 | 12593135 | 3 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125931352 | 12593135 | OT |
| 125931352 | 12593135 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125931352 | 12593135 | Balance disorder | |
| 125931352 | 12593135 | Disorientation | |
| 125931352 | 12593135 | Hyponatraemia | |
| 125931352 | 12593135 | Nausea | |
| 125931352 | 12593135 | Osmotic demyelination syndrome | |
| 125931352 | 12593135 | Speech disorder | |
| 125931352 | 12593135 | Vomiting |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |