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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126147032 | 12614703 | 2 | F | 20160718 | 20160912 | 20160802 | 20160914 | EXP | CO-JNJFOC-20160221507 | JANSSEN | 61.20 | YR | A | F | Y | 77.00000 | KG | 20160914 | OT | CO | CO |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126147032 | 12614703 | 1 | PS | RISPERDAL CONSTA | RISPERIDONE | 1 | Intramuscular | N | UNKNOWN | 21346 | 25 | MG | MICROSPHERES | ||||||
| 126147032 | 12614703 | 2 | SS | RISPERDAL | RISPERIDONE | 1 | Unknown | 0-0-1 | U | U | 20272 | 2 | MG | UNSPECIFIED | |||||
| 126147032 | 12614703 | 3 | SS | CLONAZEPAM. | CLONAZEPAM | 1 | Unknown | 4 DROPS | U | 0 | 2.5 | MG | UNSPECIFIED | ||||||
| 126147032 | 12614703 | 4 | C | INSULIN | INSULIN NOS | 1 | Unknown | (APPROXIMATELY 1 YEAR AGO) | 0 | 40 | IU | UNSPECIFIED | |||||||
| 126147032 | 12614703 | 5 | C | INSULIN | INSULIN NOS | 1 | Unknown | 0 | 46 | IU | UNSPECIFIED | Q12H | |||||||
| 126147032 | 12614703 | 6 | C | VALPROIC ACID. | VALPROIC ACID | 1 | Unknown | 250 MG 2-1-2 | 0 | 1250 | MG | UNSPECIFIED | TID | ||||||
| 126147032 | 12614703 | 7 | C | METFORMIN | METFORMIN HYDROCHLORIDE | 1 | Unknown | 0-1-0 | 0 | 850 | MG | UNSPECIFIED | QD | ||||||
| 126147032 | 12614703 | 8 | C | LEVOTHYROXINE SODIUM. | LEVOTHYROXINE SODIUM | 1 | Unknown | ONE TABLET ON AN EMPTY STOMACH | 0 | 100 | UG | UNSPECIFIED | QD | ||||||
| 126147032 | 12614703 | 9 | C | HYDROCHLOROTHIAZIDE. | HYDROCHLOROTHIAZIDE | 1 | Unknown | ONE TABLET AT 9:00 AM | 0 | 25 | MG | UNSPECIFIED | QD | ||||||
| 126147032 | 12614703 | 10 | C | LOSARTAN. | LOSARTAN | 1 | Unknown | ONE TABLET AT 9:00 AM | 0 | 50 | MG | UNSPECIFIED | QD | ||||||
| 126147032 | 12614703 | 11 | C | AMLODIPINE | AMLODIPINE BESYLATE | 1 | Unknown | ONE TABLET AT 9:00 AM | 0 | 5 | MG | UNSPECIFIED | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126147032 | 12614703 | 1 | Bipolar disorder |
| 126147032 | 12614703 | 2 | Product used for unknown indication |
| 126147032 | 12614703 | 3 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126147032 | 12614703 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126147032 | 12614703 | Aggression | |
| 126147032 | 12614703 | Anxiety | |
| 126147032 | 12614703 | Depression | |
| 126147032 | 12614703 | Drug ineffective | |
| 126147032 | 12614703 | Restlessness |
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 |
|---|---|---|---|---|---|---|
| 126147032 | 12614703 | 1 | 20130108 | 0 | ||
| 126147032 | 12614703 | 4 | 2015 | 0 | ||
| 126147032 | 12614703 | 6 | 2012 | 0 |