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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127733511 | 12773351 | 1 | I | 20160917 | 20160922 | 20160922 | EXP | US-MYLANLABS-2016M1040360 | MYLAN | KELLY DL, PATCHAN KM, RICHARDSON C, VYAS G.. THE RISK OF SUICIDE AFTER CLOZAPINE DISCONTINUATION: CAUSE FOR CONCERN.. ANNALS OF CLINICAL PSYCHIATRY.. 2015;27(4):253-6 | 0.00 | Y | 0.00000 | 20160922 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127733511 | 12773351 | 1 | PS | CLOZAPINE. | CLOZAPINE | 1 | 300 MG, QHS | U | 75417 | 300 | MG | TABLET | QD | ||||||
| 127733511 | 12773351 | 2 | SS | CLOZAPINE. | CLOZAPINE | 1 | U | 75417 | TABLET | ||||||||||
| 127733511 | 12773351 | 3 | SS | CITALOPRAM | CITALOPRAM HYDROBROMIDE | 1 | 40 MG, QD | D | 0 | 40 | MG | TABLET | QD | ||||||
| 127733511 | 12773351 | 4 | SS | CITALOPRAM | CITALOPRAM HYDROBROMIDE | 1 | D | 0 | TABLET | ||||||||||
| 127733511 | 12773351 | 5 | SS | MODAFINIL. | MODAFINIL | 1 | 200 MG, QD | D | 0 | 200 | MG | TABLET | QD | ||||||
| 127733511 | 12773351 | 6 | SS | MODAFINIL. | MODAFINIL | 1 | D | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127733511 | 12773351 | 1 | Suicidal ideation |
| 127733511 | 12773351 | 2 | Somatic delusion |
| 127733511 | 12773351 | 3 | Suicidal ideation |
| 127733511 | 12773351 | 4 | Somatic delusion |
| 127733511 | 12773351 | 5 | Suicidal ideation |
| 127733511 | 12773351 | 6 | Somatic delusion |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127733511 | 12773351 | OT |
| 127733511 | 12773351 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127733511 | 12773351 | Completed suicide | |
| 127733511 | 12773351 | Psychotic disorder | |
| 127733511 | 12773351 | Rebound effect | |
| 127733511 | 12773351 | Sedation | |
| 127733511 | 12773351 | Therapy non-responder |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |