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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127408411 | 12740841 | 1 | I | 20160502 | 20160914 | 20160914 | PER | US-TEVA-657450USA | TEVA | 0.00 | M | Y | 0.00000 | 20160914 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127408411 | 12740841 | 1 | PS | FLUOXETINE | FLUOXETINE HYDROCHLORIDE | 1 | 10 MILLIGRAM DAILY; 60-80 MG | N | UNKNOWN | 74803 | 10 | MG | CAPSULE | QD | |||||
| 127408411 | 12740841 | 2 | SS | FLUOXETINE | FLUOXETINE HYDROCHLORIDE | 1 | N | UNKNOWN | 74803 | ||||||||||
| 127408411 | 12740841 | 3 | SS | FLUOXETINE | FLUOXETINE HYDROCHLORIDE | 1 | N | UNKNOWN | 74803 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127408411 | 12740841 | 1 | Anxiety |
| 127408411 | 12740841 | 2 | Depression |
| 127408411 | 12740841 | 3 | Affective disorder |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127408411 | 12740841 | Abnormal dreams | |
| 127408411 | 12740841 | Agitation | |
| 127408411 | 12740841 | Asthenia | |
| 127408411 | 12740841 | Ejaculation delayed | |
| 127408411 | 12740841 | Insomnia | |
| 127408411 | 12740841 | Lethargy | |
| 127408411 | 12740841 | Myalgia | |
| 127408411 | 12740841 | Neuralgia | |
| 127408411 | 12740841 | Product measured potency issue | |
| 127408411 | 12740841 | Product substitution issue | |
| 127408411 | 12740841 | Sleep disorder |
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 |
|---|---|---|---|---|---|---|
| 127408411 | 12740841 | 1 | 20160506 | 0 |