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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125426052 | 12542605 | 2 | F | 20160317 | 20160718 | 20160709 | 20160822 | PER | US-JNJFOC-20160607192 | JANSSEN | 30.67 | YR | A | M | Y | 89.81000 | KG | 20160822 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125426052 | 12542605 | 1 | SS | INVEGA SUSTENNA | PALIPERIDONE PALMITATE | 1 | Intramuscular | Y | U | 0 | 234 | MG | INJECTION | ||||||
| 125426052 | 12542605 | 2 | SS | INVEGA SUSTENNA | PALIPERIDONE PALMITATE | 1 | Intramuscular | Y | U | 0 | 156 | MG | INJECTION | ||||||
| 125426052 | 12542605 | 3 | SS | INVEGA SUSTENNA | PALIPERIDONE PALMITATE | 1 | Intramuscular | Y | U | 0 | 117 | MG | INJECTION | ||||||
| 125426052 | 12542605 | 4 | PS | INVEGA SUSTENNA | PALIPERIDONE PALMITATE | 1 | Intramuscular | Y | U | 22264 | 117 | MG | INJECTION | ||||||
| 125426052 | 12542605 | 5 | C | COGENTIN | BENZTROPINE MESYLATE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 125426052 | 12542605 | 6 | C | NEURONTIN | GABAPENTIN | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 125426052 | 12542605 | 7 | C | LITHIUM. | LITHIUM | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 125426052 | 12542605 | 8 | C | LAMICTAL | LAMOTRIGINE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 125426052 | 12542605 | 9 | C | BENADRYL | DIPHENHYDRAMINE HYDROCHLORIDE | 1 | Unknown | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125426052 | 12542605 | 1 | Bipolar disorder |
| 125426052 | 12542605 | 2 | Bipolar disorder |
| 125426052 | 12542605 | 3 | Bipolar disorder |
| 125426052 | 12542605 | 4 | Bipolar disorder |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125426052 | 12542605 | Akathisia | |
| 125426052 | 12542605 | Bruxism | |
| 125426052 | 12542605 | Dizziness | |
| 125426052 | 12542605 | Erectile dysfunction | |
| 125426052 | 12542605 | Hand deformity | |
| 125426052 | 12542605 | Limb discomfort | |
| 125426052 | 12542605 | Motion sickness | |
| 125426052 | 12542605 | Off label use | |
| 125426052 | 12542605 | Product use issue | |
| 125426052 | 12542605 | Restless legs syndrome | |
| 125426052 | 12542605 | Seborrhoea | |
| 125426052 | 12542605 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 125426052 | 12542605 | 1 | 20160317 | 0 | ||
| 125426052 | 12542605 | 2 | 20160323 | 0 | ||
| 125426052 | 12542605 | 3 | 20160415 | 0 | ||
| 125426052 | 12542605 | 4 | 20160513 | 0 |