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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127861661 | 12786166 | 1 | I | 20160921 | 20160927 | 20160927 | EXP | US-SUNOVION-2016SUN002350 | SUNOVION | ITTASAKUL P, ARCHER A, KEZMAN J, ATSARIYASING W, GOLDMAN M. RAPID RECHALLENGE WITH CLOZAPINE FOLLOWING PRONOUNCED MYOCARDITIS IN A TREATMENT-RESISTANT SCHIZOPHRENIA PATIENT. CLINICAL SCHIZOPHRENIA AND RELATED PSYCHOSES. 2016;SUMMER 2016:120-122 | 20.00 | YR | M | Y | 0.00000 | 20160927 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127861661 | 12786166 | 1 | PS | LATUDA | LURASIDONE HYDROCHLORIDE | 1 | Oral | 80 MG, QD | Y | 200603 | 80 | MG | TABLET | QD | |||||
| 127861661 | 12786166 | 2 | SS | LATUDA | LURASIDONE HYDROCHLORIDE | 1 | Oral | 240 MG, QD | Y | 200603 | 240 | MG | TABLET | QD | |||||
| 127861661 | 12786166 | 3 | SS | CLOZAPINE. | CLOZAPINE | 1 | UNK | D | 0 | ||||||||||
| 127861661 | 12786166 | 4 | SS | CLOZAPINE. | CLOZAPINE | 1 | 450 MG, UNK | D | 0 | 450 | MG | ||||||||
| 127861661 | 12786166 | 5 | SS | CLOZAPINE. | CLOZAPINE | 1 | 25 MG, UNK | D | 0 | 25 | MG | ||||||||
| 127861661 | 12786166 | 6 | SS | CLOZAPINE. | CLOZAPINE | 1 | 50 MG, UNK | D | 0 | 50 | MG | ||||||||
| 127861661 | 12786166 | 7 | SS | CLOZAPINE. | CLOZAPINE | 1 | 75 MG, UNK | D | 0 | 75 | MG | ||||||||
| 127861661 | 12786166 | 8 | SS | CLOZAPINE. | CLOZAPINE | 1 | 100 MG, QD | D | 0 | 100 | MG | QD | |||||||
| 127861661 | 12786166 | 9 | SS | CLOZAPINE. | CLOZAPINE | 1 | 125 MG, QD | D | 0 | 125 | MG | QD | |||||||
| 127861661 | 12786166 | 10 | SS | CLOZAPINE. | CLOZAPINE | 1 | 200 MG, QD | D | 0 | 200 | MG | QD | |||||||
| 127861661 | 12786166 | 11 | SS | CLOZAPINE. | CLOZAPINE | 1 | 750 MG, UNK | D | 0 | 750 | MG | ||||||||
| 127861661 | 12786166 | 12 | SS | CLOZAPINE. | CLOZAPINE | 1 | UNK | D | 0 | ||||||||||
| 127861661 | 12786166 | 13 | SS | OLANZAPINE. | OLANZAPINE | 1 | 40 MG, QD | D | 0 | 40 | MG | QD | |||||||
| 127861661 | 12786166 | 14 | SS | OLANZAPINE. | OLANZAPINE | 1 | UNK | D | 0 | ||||||||||
| 127861661 | 12786166 | 15 | C | RISPERIDONE. | RISPERIDONE | 1 | 3 MG, QD | 0 | 3 | MG | QD | ||||||||
| 127861661 | 12786166 | 16 | C | ZIPRASIDONE. | ZIPRASIDONE | 1 | 80 MG, QD | 0 | 80 | MG | QD | ||||||||
| 127861661 | 12786166 | 17 | C | PERPHENAZINE. | PERPHENAZINE | 1 | 24 MG, QD | 0 | 24 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127861661 | 12786166 | 1 | Schizophrenia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127861661 | 12786166 | OT |
| 127861661 | 12786166 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127861661 | 12786166 | Aggression | |
| 127861661 | 12786166 | C-reactive protein increased | |
| 127861661 | 12786166 | Chest pain | |
| 127861661 | 12786166 | Ejection fraction decreased | |
| 127861661 | 12786166 | Electrocardiogram T wave abnormal | |
| 127861661 | 12786166 | Eosinophil count increased | |
| 127861661 | 12786166 | Hallucination, auditory | |
| 127861661 | 12786166 | Headache | |
| 127861661 | 12786166 | Leukocytosis | |
| 127861661 | 12786166 | Mental impairment | |
| 127861661 | 12786166 | Myocarditis | |
| 127861661 | 12786166 | Nasal congestion | |
| 127861661 | 12786166 | Oropharyngeal pain | |
| 127861661 | 12786166 | Paranoia | |
| 127861661 | 12786166 | Pyrexia | |
| 127861661 | 12786166 | Tachycardia | |
| 127861661 | 12786166 | Troponin I increased | |
| 127861661 | 12786166 | Ventricular hypokinesia |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |