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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118410932 | 11841093 | 2 | F | 20160818 | 20151216 | 20160830 | EXP | US-JNJFOC-20151210858 | JANSSEN | HUYBRECHTS KF, BATEMAN BT, PATORNO E, DESAI R, MOGUN H, HERNANDEZ-DIAZ S. ANTIPSYCHOTIC MEDICATION USE DURING PREGNANCY AND RISK OF CONGENITAL CARDIAC MALFORMATIONS. PHARMACOEPIDEMIOLOGY AND DRUG SAFETY 22-AUG-2015;24:206. HUYBRECHTS K, HERN?NDEZ-DIAZ S, PATORNO E, DESAI RJ, MOGUN H, DEJENE SZ, ET AL. ANTIPSYCHOTIC USE IN PREGNANCY AND THE RISK FOR CONGENITAL MALFORMATIONS. JAMA PSYCHIATRY. | 0.00 | Y | 0.00000 | 20160830 | OT | US | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118410932 | 11841093 | 1 | SS | RISPERIDONE. | RISPERIDONE | 1 | Transplacental | U | U | 0 | UNSPECIFIED | ||||||||
| 118410932 | 11841093 | 2 | SS | RISPERIDONE. | RISPERIDONE | 1 | Transplacental | U | U | 0 | UNSPECIFIED | ||||||||
| 118410932 | 11841093 | 3 | SS | RISPERIDONE. | RISPERIDONE | 1 | Transplacental | U | U | 0 | UNSPECIFIED | ||||||||
| 118410932 | 11841093 | 4 | SS | RISPERIDONE. | RISPERIDONE | 1 | Transplacental | U | U | 0 | UNSPECIFIED | ||||||||
| 118410932 | 11841093 | 5 | SS | RISPERIDONE. | RISPERIDONE | 1 | Transplacental | U | U | 0 | UNSPECIFIED | ||||||||
| 118410932 | 11841093 | 6 | PS | RISPERIDONE. | RISPERIDONE | 1 | Transplacental | U | U | 20272 | UNSPECIFIED | ||||||||
| 118410932 | 11841093 | 7 | SS | RISPERIDONE. | RISPERIDONE | 1 | Transplacental | U | U | 0 | MICROSPHERES | ||||||||
| 118410932 | 11841093 | 8 | SS | RISPERIDONE. | RISPERIDONE | 1 | Transplacental | U | U | 0 | MICROSPHERES | ||||||||
| 118410932 | 11841093 | 9 | SS | RISPERIDONE. | RISPERIDONE | 1 | Transplacental | U | U | 0 | MICROSPHERES | ||||||||
| 118410932 | 11841093 | 10 | SS | RISPERIDONE. | RISPERIDONE | 1 | Transplacental | U | U | 0 | MICROSPHERES | ||||||||
| 118410932 | 11841093 | 11 | SS | RISPERIDONE. | RISPERIDONE | 1 | Transplacental | U | U | 0 | MICROSPHERES | ||||||||
| 118410932 | 11841093 | 12 | SS | RISPERIDONE. | RISPERIDONE | 1 | Transplacental | U | U | 21346 | MICROSPHERES | ||||||||
| 118410932 | 11841093 | 13 | C | NALTREXONE HYDROCHLORIDE. | NALTREXONE HYDROCHLORIDE | 1 | Transplacental | 0 | TABLETS | ||||||||||
| 118410932 | 11841093 | 14 | C | NALTREXONE HYDROCHLORIDE. | NALTREXONE HYDROCHLORIDE | 1 | Transplacental | 0 | TABLETS | ||||||||||
| 118410932 | 11841093 | 15 | C | FLUCONAZOLE. | FLUCONAZOLE | 1 | Transplacental | 0 | UNSPECIFIED | ||||||||||
| 118410932 | 11841093 | 16 | C | DANAZOL. | DANAZOL | 1 | Transplacental | 0 | UNSPECIFIED | ||||||||||
| 118410932 | 11841093 | 17 | C | METHADONE HYDROCHLORIDE. | METHADONE HYDROCHLORIDE | 1 | Transplacental | 0 | UNSPECIFIED | ||||||||||
| 118410932 | 11841093 | 18 | C | METHADONE HYDROCHLORIDE. | METHADONE HYDROCHLORIDE | 1 | Transplacental | 0 | UNSPECIFIED | ||||||||||
| 118410932 | 11841093 | 19 | C | NALOXONE HYDROCHLORIDE. | NALOXONE HYDROCHLORIDE | 1 | Transplacental | 0 | UNSPECIFIED | ||||||||||
| 118410932 | 11841093 | 20 | C | NALOXONE HYDROCHLORIDE. | NALOXONE HYDROCHLORIDE | 1 | Transplacental | 0 | UNSPECIFIED | ||||||||||
| 118410932 | 11841093 | 21 | C | PROPYLTHIOURACIL. | PROPYLTHIOURACIL | 1 | Transplacental | 0 | UNSPECIFIED | ||||||||||
| 118410932 | 11841093 | 22 | C | METHIMAZOLE. | METHIMAZOLE | 1 | Transplacental | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 118410932 | 11841093 | 1 | Attention deficit/hyperactivity disorder |
| 118410932 | 11841093 | 2 | Anxiety |
| 118410932 | 11841093 | 3 | Schizophrenia |
| 118410932 | 11841093 | 4 | Depression |
| 118410932 | 11841093 | 5 | Psychotic disorder |
| 118410932 | 11841093 | 6 | Bipolar disorder |
| 118410932 | 11841093 | 7 | Attention deficit/hyperactivity disorder |
| 118410932 | 11841093 | 8 | Anxiety |
| 118410932 | 11841093 | 9 | Schizophrenia |
| 118410932 | 11841093 | 10 | Depression |
| 118410932 | 11841093 | 11 | Psychotic disorder |
| 118410932 | 11841093 | 12 | Bipolar disorder |
| 118410932 | 11841093 | 13 | Drug dependence |
| 118410932 | 11841093 | 14 | Drug abuse |
| 118410932 | 11841093 | 15 | Drug abuse |
| 118410932 | 11841093 | 16 | Drug abuse |
| 118410932 | 11841093 | 17 | Drug dependence |
| 118410932 | 11841093 | 18 | Drug abuse |
| 118410932 | 11841093 | 19 | Drug dependence |
| 118410932 | 11841093 | 20 | Drug abuse |
| 118410932 | 11841093 | 21 | Product used for unknown indication |
| 118410932 | 11841093 | 22 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 118410932 | 11841093 | CA |
| 118410932 | 11841093 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 118410932 | 11841093 | Congenital anomaly | |
| 118410932 | 11841093 | Foetal exposure during pregnancy | |
| 118410932 | 11841093 | Heart disease congenital |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |