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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125508542 | 12550854 | 2 | F | 201601 | 20160705 | 20160712 | 20160715 | EXP | FR-TEVA-673400ISR | TEVA | 28.73 | YR | F | Y | 0.00000 | 20160715 | OT | FR | FR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125508542 | 12550854 | 1 | PS | alprazolam 0.25 mg | ALPRAZOLAM | 1 | Oral | 68 DOSAGE FORMS DAILY; I.E. 17 MG IN ONE INTAKE | 74294 | 68 | DF | TABLET | QD | ||||||
| 125508542 | 12550854 | 2 | SS | zopiclone 7.5 mg | ZOPICLONE | 1 | Oral | 11 DOSAGE FORMS DAILY; I.E. 82.5 MG IN ONE INTAKE | 0 | 11 | DF | TABLET | QD | ||||||
| 125508542 | 12550854 | 3 | SS | VENLAFAXINE | VENLAFAXINE HYDROCHLORIDE | 1 | Oral | 5925 MILLIGRAM DAILY; I.E. 79 TABLETS IN ONE INTAKE | 0 | 5925 | MG | TABLET | QD | ||||||
| 125508542 | 12550854 | 4 | SS | ibuprofen 400 mg | IBUPROFEN | 1 | Oral | 4800 MILLIGRAM DAILY; I.E. 12 TABLETS IN ONE INTAKE | 71145 | 4800 | MG | TABLET | QD | ||||||
| 125508542 | 12550854 | 5 | SS | ketoprofen 100 mg | KETOPROFEN | 1 | Unknown | 1700 MILLIGRAM DAILY; I.E. 17 TABLETS IN ONE INTAKE | 73515 | 1700 | MG | QD | |||||||
| 125508542 | 12550854 | 6 | SS | SPASFON | PHLOROGLUCINOL | 1 | Oral | 0 | 1600 | MG | COATED TABLET | QD | |||||||
| 125508542 | 12550854 | 7 | SS | omeprazole 20 mg | OMEPRAZOLE | 1 | Oral | 100 MILLIGRAM DAILY; I.E. 5 TABLETS IN ONE INTAKE | 0 | 100 | MG | TABLET | QD | ||||||
| 125508542 | 12550854 | 8 | SS | baclofen 10 mg | BACLOFEN | 1 | Oral | 960 MILLIGRAM DAILY; I.E. 96 TABLETS IN ONE INTAKE | 0 | 960 | MG | TABLET | QD | ||||||
| 125508542 | 12550854 | 9 | SS | XEROQUEL LP 300 mg | QUETIAPINE FUMARATE | 1 | Oral | 44 DOSAGE FORMS DAILY; EXACT FORM: PROLONGED RELEASE TABLET. 13200 MG IN ONE INTAKE | 0 | 44 | DF | TABLET | QD | ||||||
| 125508542 | 12550854 | 10 | SS | THERALENE 5 mg | TRIMEPRAZINE | 1 | Oral | 43 DOSAGE FORMS DAILY; I.E. 215 MG IN ONE INTAKE | 0 | 43 | DF | FILM-COATED TABLET | QD | ||||||
| 125508542 | 12550854 | 11 | SS | VERATRAN 10 mg | CLOTIAZEPAM | 1 | Oral | 9 DOSAGE FORMS DAILY; I.E. 90 MG IN ONE INTAKE | 0 | 9 | DF | TABLET | QD | ||||||
| 125508542 | 12550854 | 12 | SS | ATARAX | HYDROXYZINEHYDROXYZINE HYDROCHLORIDE | 1 | Oral | 21 DOSAGE FORMS DAILY; I.E. 525 MG IN ONE INTAKE | 0 | 21 | DF | FILM-COATED TABLET | QD | ||||||
| 125508542 | 12550854 | 13 | SS | ZYRTEC | CETIRIZINE HYDROCHLORIDE | 1 | Oral | 150 MILLIGRAM DAILY; I.E. 15 TABLETS IN ONE INTAKE | 0 | 150 | MG | QD | |||||||
| 125508542 | 12550854 | 14 | SS | acetylsalicylic acid | ASPIRIN | 1 | Oral | 14 DOSAGE FORMS DAILY; 14 DF IN ONE INTAKE | 0 | 14 | DF | TABLET | QD | ||||||
| 125508542 | 12550854 | 15 | SS | NALTREXONE HYDROCHLORIDE 50 MG TABLET | NALTREXONE HYDROCHLORIDE | 1 | Oral | 1400 MILLIGRAM DAILY; I.E. 28 TABLETS IN ONE INTAKE | 0 | 1400 | MG | TABLET | QD | ||||||
| 125508542 | 12550854 | 16 | SS | DOLIPRANE | ACETAMINOPHEN | 1 | Oral | 8 GRAM DAILY; I.E. 8 TABLETS IN ONE INTAKE | 0 | 8 | G | TABLET | QD | ||||||
| 125508542 | 12550854 | 17 | SS | PYOSTACINE 500 mg | PRISTINAMYCIN | 1 | Oral | 10 GRAM DAILY; I.E. 20 TABLETS IN ONE INTAKE | 0 | 10 | G | FILM-COATED TABLET | QD | ||||||
| 125508542 | 12550854 | 18 | SS | SULFARLEM 25 mg | ANETHOLTRITHION | 1 | Oral | 3750 MILLIGRAM DAILY; I.E. 150 TABLETS IN ONE INTAKE | 0 | 3750 | MG | TABLET | QD | ||||||
| 125508542 | 12550854 | 19 | SS | DAFLON 700 mg | DIOSMINHESPERIDIN | 1 | Oral | 59.5 GRAM DAILY; I.E. 85 TABLETS IN ONE INTAKE | 0 | 59.5 | G | TABLET | QD |
Indications of drugs used
| no results found |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125508542 | 12550854 | HO |
| 125508542 | 12550854 | LT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125508542 | 12550854 | Coma | |
| 125508542 | 12550854 | Electrocardiogram QT prolonged | |
| 125508542 | 12550854 | Hepatocellular injury | |
| 125508542 | 12550854 | Hypotension | |
| 125508542 | 12550854 | Mydriasis | |
| 125508542 | 12550854 | Poisoning deliberate | |
| 125508542 | 12550854 | Status epilepticus |
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 |
|---|---|---|---|---|---|---|
| 125508542 | 12550854 | 1 | 201601 | 201601 | 0 | |
| 125508542 | 12550854 | 2 | 201601 | 201601 | 0 | |
| 125508542 | 12550854 | 3 | 201601 | 201601 | 0 | |
| 125508542 | 12550854 | 4 | 201601 | 201601 | 0 | |
| 125508542 | 12550854 | 5 | 201601 | 201601 | 0 | |
| 125508542 | 12550854 | 6 | 201601 | 201601 | 0 | |
| 125508542 | 12550854 | 7 | 201601 | 201601 | 0 | |
| 125508542 | 12550854 | 8 | 201601 | 201601 | 0 | |
| 125508542 | 12550854 | 9 | 201601 | 201601 | 0 | |
| 125508542 | 12550854 | 10 | 201601 | 201601 | 0 | |
| 125508542 | 12550854 | 11 | 201601 | 201601 | 0 | |
| 125508542 | 12550854 | 12 | 201601 | 201601 | 0 | |
| 125508542 | 12550854 | 13 | 201601 | 201601 | 0 | |
| 125508542 | 12550854 | 14 | 201601 | 201601 | 0 | |
| 125508542 | 12550854 | 15 | 201601 | 201601 | 0 | |
| 125508542 | 12550854 | 16 | 201601 | 201601 | 0 | |
| 125508542 | 12550854 | 17 | 201601 | 201601 | 0 | |
| 125508542 | 12550854 | 18 | 201601 | 201601 | 0 | |
| 125508542 | 12550854 | 19 | 201601 | 201601 | 0 |