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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125915531 | 12591553 | 1 | I | 20160714 | 20160726 | 20160726 | EXP | US-ALEMBIC PHARMACUETICALS LIMITED-2016SCAL000586 | ALEMBIC | 0.00 | Y | 0.00000 | 20160722 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125915531 | 12591553 | 1 | SS | ARIPIPRAZOLE. | ARIPIPRAZOLE | 1 | UNK | 0 | |||||||||||
| 125915531 | 12591553 | 2 | PS | LITHIUM CARBONATE. | LITHIUM CARBONATE | 1 | UNK | 79159 | |||||||||||
| 125915531 | 12591553 | 3 | SS | VENLAFAXINE HYDROCHLORIDE. | VENLAFAXINE HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 125915531 | 12591553 | 4 | SS | FLUOXETINE HYDROCHLORIDE. | FLUOXETINE HYDROCHLORIDE | 1 | UNK | U | 0 | ||||||||||
| 125915531 | 12591553 | 5 | SS | OLANZAPINE. | OLANZAPINE | 1 | UNK | 0 | |||||||||||
| 125915531 | 12591553 | 6 | SS | ZIPRASIDONE. | ZIPRASIDONE | 1 | UNK | 0 | |||||||||||
| 125915531 | 12591553 | 7 | C | GUANFACINE. | GUANFACINE | 1 | UNK | 0 | |||||||||||
| 125915531 | 12591553 | 8 | C | CITALOPRAM | CITALOPRAM HYDROBROMIDE | 1 | 10 MG, QD | 0 | 10 | MG | |||||||||
| 125915531 | 12591553 | 9 | C | FLUVOXAMINE | FLUVOXAMINE | 1 | UNK | 0 | |||||||||||
| 125915531 | 12591553 | 10 | C | BUPROPION. | BUPROPION | 1 | UNK | 0 | |||||||||||
| 125915531 | 12591553 | 11 | C | TRAZODONE | TRAZODONE HYDROCHLORIDE | 1 | UNK | 0 | |||||||||||
| 125915531 | 12591553 | 12 | C | LORAZEPAM. | LORAZEPAM | 1 | UNK | 0 | |||||||||||
| 125915531 | 12591553 | 13 | C | CLOZAPINE. | CLOZAPINE | 1 | 175 MG, QD | 0 | 175 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125915531 | 12591553 | 1 | Product used for unknown indication |
| 125915531 | 12591553 | 2 | Product used for unknown indication |
| 125915531 | 12591553 | 3 | Attention deficit/hyperactivity disorder |
| 125915531 | 12591553 | 4 | Depression |
| 125915531 | 12591553 | 5 | Product used for unknown indication |
| 125915531 | 12591553 | 6 | Product used for unknown indication |
| 125915531 | 12591553 | 7 | Attention deficit/hyperactivity disorder |
| 125915531 | 12591553 | 8 | Depression |
| 125915531 | 12591553 | 9 | Depression |
| 125915531 | 12591553 | 10 | Sleep disorder |
| 125915531 | 12591553 | 11 | Sleep disorder |
| 125915531 | 12591553 | 12 | Product used for unknown indication |
| 125915531 | 12591553 | 13 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125915531 | 12591553 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125915531 | 12591553 | Activities of daily living impaired | |
| 125915531 | 12591553 | Agitation | |
| 125915531 | 12591553 | Catatonia | |
| 125915531 | 12591553 | Condition aggravated | |
| 125915531 | 12591553 | Drug ineffective | |
| 125915531 | 12591553 | Drug ineffective for unapproved indication | |
| 125915531 | 12591553 | Paranoia | |
| 125915531 | 12591553 | Psychotic disorder | |
| 125915531 | 12591553 | Tearfulness |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |