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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127984411 | 12798441 | 1 | I | 20160915 | 20160930 | 20160930 | EXP | US-APOTEX-2016AP012633 | APOTEX | 66.00 | YR | F | Y | 0.00000 | 20160930 | CN | GB | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127984411 | 12798441 | 1 | PS | PAROXETINE HYDROCHLORIDE. | PAROXETINE HYDROCHLORIDE | 1 | Unknown | UNK | U | U | 75356 | TABLET | |||||||
| 127984411 | 12798441 | 2 | SS | QUETIAPINE FUMARATE. | QUETIAPINE FUMARATE | 1 | Unknown | UNK | U | U | 0 | TABLET | |||||||
| 127984411 | 12798441 | 3 | SS | LITHIUM CARBONATE. | LITHIUM CARBONATE | 1 | Unknown | UNK | U | U | 0 | CAPSULE | |||||||
| 127984411 | 12798441 | 4 | SS | FLUOXETINE ORAL SOLUTION USP | FLUOXETINE HYDROCHLORIDE | 1 | Unknown | UNK | U | U | 0 | ORAL SOLUTION | |||||||
| 127984411 | 12798441 | 5 | SS | HALOPERIDOL. | HALOPERIDOL | 1 | Unknown | UNK | U | U | 0 | INJECTION | |||||||
| 127984411 | 12798441 | 6 | SS | DULOXETINE HYDROCHLORIDE DELAYED-RELEASE CAPSULES | DULOXETINE HYDROCHLORIDE | 1 | Unknown | UNK | U | U | 0 | CAPSULE | |||||||
| 127984411 | 12798441 | 7 | SS | MIRTAZAPINE. | MIRTAZAPINE | 1 | Unknown | 40 MG, BID | U | U | 0 | 40 | MG | TABLET | BID | ||||
| 127984411 | 12798441 | 8 | SS | CLONAZEPAM TABLETS USP | CLONAZEPAM | 1 | Unknown | 1 MG, TID | U | U | 0 | 1 | MG | TABLET | TID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127984411 | 12798441 | 1 | Depression |
| 127984411 | 12798441 | 2 | Depression |
| 127984411 | 12798441 | 3 | Depression |
| 127984411 | 12798441 | 4 | Depression |
| 127984411 | 12798441 | 5 | Product used for unknown indication |
| 127984411 | 12798441 | 6 | Product used for unknown indication |
| 127984411 | 12798441 | 7 | Product used for unknown indication |
| 127984411 | 12798441 | 8 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127984411 | 12798441 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127984411 | 12798441 | Abnormal behaviour | |
| 127984411 | 12798441 | Akathisia | |
| 127984411 | 12798441 | Anxiety | |
| 127984411 | 12798441 | Condition aggravated | |
| 127984411 | 12798441 | Restlessness | |
| 127984411 | 12798441 | Treatment failure | |
| 127984411 | 12798441 | Weight decreased |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |