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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125405081 | 12540508 | 1 | I | 20120724 | 20160708 | 20160708 | EXP | AT-CIPLA LTD.-2013AT00179 | CIPLA | LETMAIER M, PAINOLD A, HOLL AK, GROHMANN R, VERGIN H. SEVERE PSYCHOTIC EXACERBATION DURING COMBINED TREATMENT WITH ARIPIPRAZOLE/HALOPERIDOL AFTER PRIOR TREATMENT WITH RISPERIDONE. INTERNATIONAL JOURNAL OF PSYCHIATRY IN CLINICAL PRACTICE. 2012;16:153 TO 156 | 39.00 | YR | F | Y | 0.00000 | 20160708 | OT | AT | AT |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125405081 | 12540508 | 1 | PS | RISPERIDONE. | RISPERIDONE | 1 | Unknown | 4 MG/DAY | Y | U | 77543 | 4 | MG | ||||||
| 125405081 | 12540508 | 2 | I | MIRTAZAPINE. | MIRTAZAPINE | 1 | Unknown | 30 MG/DAY | Y | U | 0 | 30 | MG | ||||||
| 125405081 | 12540508 | 3 | I | MIRTAZAPINE. | MIRTAZAPINE | 1 | Unknown | 15 MG/DAY | Y | U | 0 | 15 | MG | ||||||
| 125405081 | 12540508 | 4 | I | VENLAFAXINE | VENLAFAXINE HYDROCHLORIDE | 1 | Unknown | 150 MG/DAY | Y | U | 0 | 150 | MG | ||||||
| 125405081 | 12540508 | 5 | I | VENLAFAXINE | VENLAFAXINE HYDROCHLORIDE | 1 | Unknown | 225 MG/DAY | Y | U | 0 | 225 | MG | ||||||
| 125405081 | 12540508 | 6 | I | VENLAFAXINE | VENLAFAXINE HYDROCHLORIDE | 1 | Unknown | 150 MG/DAY | Y | U | 0 | 150 | MG | ||||||
| 125405081 | 12540508 | 7 | I | ARIPIPRAZOLE. | ARIPIPRAZOLE | 1 | Unknown | 5 MG/DAY | Y | U | 0 | 5 | MG | ||||||
| 125405081 | 12540508 | 8 | I | ARIPIPRAZOLE. | ARIPIPRAZOLE | 1 | Unknown | 10 MG/DAY | Y | U | 0 | 10 | MG | ||||||
| 125405081 | 12540508 | 9 | I | ARIPIPRAZOLE. | ARIPIPRAZOLE | 1 | Unknown | 15 MG/DAY | Y | U | 0 | 15 | MG | ||||||
| 125405081 | 12540508 | 10 | I | ARIPIPRAZOLE. | ARIPIPRAZOLE | 1 | Unknown | 20 MG/DAY | Y | U | 0 | 20 | MG | ||||||
| 125405081 | 12540508 | 11 | I | ARIPIPRAZOLE. | ARIPIPRAZOLE | 1 | Unknown | 30 MG/DAY | Y | U | 0 | 30 | MG | ||||||
| 125405081 | 12540508 | 12 | I | ARIPIPRAZOLE. | ARIPIPRAZOLE | 1 | Unknown | 15 MG/DAY | Y | U | 0 | 15 | MG | ||||||
| 125405081 | 12540508 | 13 | I | HALOPERIDOL. | HALOPERIDOL | 1 | Unknown | 5 MG/DAY | Y | U | 0 | 5 | MG | ||||||
| 125405081 | 12540508 | 14 | I | HALOPERIDOL. | HALOPERIDOL | 1 | Unknown | 7.5 MG/DAY | Y | U | 0 | 7.5 | MG | ||||||
| 125405081 | 12540508 | 15 | I | HALOPERIDOL. | HALOPERIDOL | 1 | Unknown | 3 MG/DAY | Y | U | 0 | 3 | MG | ||||||
| 125405081 | 12540508 | 16 | I | LORAZEPAM. | LORAZEPAM | 1 | Unknown | 4 MG/DAY | U | U | 0 | 4 | MG | ||||||
| 125405081 | 12540508 | 17 | I | Bisoprolol | BISOPROLOL | 1 | Unknown | 5 MG, UNK | U | U | 0 | 5 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125405081 | 12540508 | 1 | Psychiatric symptom |
| 125405081 | 12540508 | 2 | Psychotic disorder |
| 125405081 | 12540508 | 4 | Depressed mood |
| 125405081 | 12540508 | 7 | Psychotic disorder |
| 125405081 | 12540508 | 13 | Psychotic disorder |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125405081 | 12540508 | OT |
| 125405081 | 12540508 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125405081 | 12540508 | Antidepressant drug level increased | |
| 125405081 | 12540508 | Drug ineffective | |
| 125405081 | 12540508 | Drug interaction | |
| 125405081 | 12540508 | Galactorrhoea | |
| 125405081 | 12540508 | Psychotic disorder | |
| 125405081 | 12540508 | Schizoaffective disorder depressive type | |
| 125405081 | 12540508 | Sedation |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |