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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125900611 | 12590061 | 1 | I | 200307 | 20160715 | 20160725 | 20160725 | EXP | GB-MYLANLABS-2016M1029654 | MYLAN | 0.00 | Y | 0.00000 | 20160725 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125900611 | 12590061 | 1 | PS | PAROXETINE. | PAROXETINE | 1 | Unknown | 20 MG, QD | 23520 | MG | U | U | 77873 | 20 | MG | QD | |||
| 125900611 | 12590061 | 2 | SS | PAROXETINE HYDROCHLORIDE. | PAROXETINE HYDROCHLORIDE | 1 | Unknown | 10MG/5ML | U | U | 0 | ||||||||
| 125900611 | 12590061 | 3 | SS | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | Unknown | 20 MG, QD | 32079.166 | MG | U | U | 0 | 20 | MG | QD | |||
| 125900611 | 12590061 | 4 | SS | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | Unknown | UNK | 32079.166 | MG | U | U | 0 | ||||||
| 125900611 | 12590061 | 5 | C | DIAZEPAM. | DIAZEPAM | 1 | Unknown | UNK | U | 0 | |||||||||
| 125900611 | 12590061 | 6 | C | DOMPERIDONE | DOMPERIDONE | 1 | 1 UNK, UNK | U | 0 | ||||||||||
| 125900611 | 12590061 | 7 | C | DULOXETINE. | DULOXETINE | 1 | Unknown | UNK | U | 0 | |||||||||
| 125900611 | 12590061 | 8 | C | ESOMEPRAZOLE | ESOMEPRAZOLE | 1 | UNK | U | 0 | ||||||||||
| 125900611 | 12590061 | 9 | C | LUSTRAL | SERTRALINE HYDROCHLORIDE | 1 | Unknown | UNK | U | 0 | |||||||||
| 125900611 | 12590061 | 10 | C | NICOTINE. | NICOTINE | 1 | UNK | U | 0 | ||||||||||
| 125900611 | 12590061 | 11 | C | REBOXETINE | REBOXETINE | 1 | UNK | U | 0 | ||||||||||
| 125900611 | 12590061 | 12 | C | SERTRALINE | SERTRALINE HYDROCHLORIDE | 1 | UNK | U | 0 | ||||||||||
| 125900611 | 12590061 | 13 | C | SIMVASTATIN. | SIMVASTATIN | 1 | UNK | U | 0 | ||||||||||
| 125900611 | 12590061 | 14 | C | TESTOSTERONE. | TESTOSTERONE | 1 | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125900611 | 12590061 | 1 | Product used for unknown indication |
| 125900611 | 12590061 | 2 | Product used for unknown indication |
| 125900611 | 12590061 | 3 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125900611 | 12590061 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125900611 | 12590061 | Abnormal behaviour | |
| 125900611 | 12590061 | Aggression | |
| 125900611 | 12590061 | Anger | |
| 125900611 | 12590061 | Anxiety | |
| 125900611 | 12590061 | Depressed mood | |
| 125900611 | 12590061 | Depression | |
| 125900611 | 12590061 | Dizziness | |
| 125900611 | 12590061 | Fatigue | |
| 125900611 | 12590061 | Feelings of worthlessness | |
| 125900611 | 12590061 | Gastrooesophageal reflux disease | |
| 125900611 | 12590061 | Insomnia | |
| 125900611 | 12590061 | Irritability | |
| 125900611 | 12590061 | Loss of libido | |
| 125900611 | 12590061 | Nervousness | |
| 125900611 | 12590061 | Self-injurious ideation | |
| 125900611 | 12590061 | Suicidal ideation | |
| 125900611 | 12590061 | Tension headache | |
| 125900611 | 12590061 | Withdrawal syndrome |
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 |
|---|---|---|---|---|---|---|
| 125900611 | 12590061 | 1 | 20000411 | 20041207 | 0 | |
| 125900611 | 12590061 | 2 | 20001110 | 0 | ||
| 125900611 | 12590061 | 3 | 19990208 | 20000411 | 0 | |
| 125900611 | 12590061 | 4 | 19980526 | 0 | ||
| 125900611 | 12590061 | 5 | 20000919 | 0 | ||
| 125900611 | 12590061 | 6 | 200609 | 0 | ||
| 125900611 | 12590061 | 8 | 200609 | 0 | ||
| 125900611 | 12590061 | 9 | 20010411 | 0 | ||
| 125900611 | 12590061 | 11 | 20020524 | 0 | ||
| 125900611 | 12590061 | 13 | 200603 | 0 | ||
| 125900611 | 12590061 | 14 | 20000510 | 200011 | 0 |