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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126468021 | 12646802 | 1 | I | 2009 | 20160801 | 20160812 | 20160812 | EXP | GB-MHRA-ADR 23161713 | GB-ALKEM LABORATORIES LIMITED-GB-ALKEM-2016-00115 | ALKEM | 51.00 | YR | F | Y | 0.00000 | 20160811 | MD | GB | GB |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126468021 | 12646802 | 1 | PS | QUETIAPINE FUMARATE. | QUETIAPINE FUMARATE | 1 | Oral | 400 MG, BID | N | U | 201504 | 400 | MG | Q12H | |||||
| 126468021 | 12646802 | 2 | SS | QUETIAPINE FUMARATE. | QUETIAPINE FUMARATE | 1 | Oral | UNKNOWN | N | U | 201504 | ||||||||
| 126468021 | 12646802 | 3 | SS | FLUOXETINE | FLUOXETINE HYDROCHLORIDE | 1 | 100 MG, UNKNOWN | N | U | 0 | 100 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126468021 | 12646802 | 1 | Product used for unknown indication |
| 126468021 | 12646802 | 3 | Anxiety |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126468021 | 12646802 | DE |
| 126468021 | 12646802 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126468021 | 12646802 | Agitation | |
| 126468021 | 12646802 | Asthma | |
| 126468021 | 12646802 | Death | |
| 126468021 | 12646802 | Drug withdrawal syndrome | |
| 126468021 | 12646802 | Interstitial lung disease | |
| 126468021 | 12646802 | Overdose | |
| 126468021 | 12646802 | Pneumonia | |
| 126468021 | 12646802 | Prescribed overdose | |
| 126468021 | 12646802 | Tremor |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|---|
| 126468021 | 12646802 | 3 | 2008 | 0 |