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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125356101 | 12535610 | 1 | I | 20040212 | 20160623 | 20160707 | 20160707 | EXP | GB-AUROBINDO-AUR-APL-2016-08386 | AUROBINDO | 0.00 | A | M | Y | 0.00000 | 20160707 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125356101 | 12535610 | 1 | PS | Paroxetine Tablet | PAROXETINE | 1 | Unknown | 15 MG, ONCE A DAY | 11130 | MG | U | 78406 | 15 | MG | TABLET | QD | |||
| 125356101 | 12535610 | 2 | SS | Paroxetine Tablet | PAROXETINE | 1 | Unknown | UNK | 11130 | MG | U | 78406 | TABLET | ||||||
| 125356101 | 12535610 | 3 | SS | Paroxetine Tablet | PAROXETINE | 1 | Oral | 20 MG, TWO TIMES A DAY | 11130 | MG | U | 78406 | 20 | MG | TABLET | BID | |||
| 125356101 | 12535610 | 4 | SS | Paroxetine Tablet | PAROXETINE | 1 | Oral | 30 MG, ONCE A DAY | 11130 | MG | U | 78406 | 30 | MG | TABLET | QD | |||
| 125356101 | 12535610 | 5 | SS | Paroxetine Tablet | PAROXETINE | 1 | Unknown | 20 MG, ONCE A DAY | 11130 | MG | U | 78406 | 20 | MG | TABLET | QD | |||
| 125356101 | 12535610 | 6 | SS | Paroxetine Tablet | PAROXETINE | 1 | Unknown | 30 MG, ONCE A DAY | 11130 | MG | U | 78406 | 30 | MG | TABLET | QD | |||
| 125356101 | 12535610 | 7 | SS | Paroxetine Tablet | PAROXETINE | 1 | Unknown | 10 MG, UNK | 11130 | MG | U | 78406 | 10 | MG | TABLET | ||||
| 125356101 | 12535610 | 8 | SS | Paroxetine Tablet | PAROXETINE | 1 | 15 MG, ONCE A DAY | 11130 | MG | U | 78406 | 15 | MG | TABLET | QD | ||||
| 125356101 | 12535610 | 9 | SS | PAROXETINE. | PAROXETINE | 1 | Oral | UNK | U | 0 | SUSPENSION | ||||||||
| 125356101 | 12535610 | 10 | SS | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | Unknown | UNK | 33400 | MG | U | 0 | TABLET | ||||||
| 125356101 | 12535610 | 11 | SS | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | Oral | 20 MG, TWO TIMES A DAY | 33400 | MG | U | 0 | 20 | MG | TABLET | BID | |||
| 125356101 | 12535610 | 12 | SS | SEROXAT | PAROXETINE HYDROCHLORIDE | 1 | Oral | 20 MG, TWO TIMES A DAY | 44440 | MG | U | 0 | 20 | MG | TABLET | BID | |||
| 125356101 | 12535610 | 13 | SS | SEROXAT | PAROXETINE HYDROCHLORIDE | 1 | UNK | 44440 | MG | U | 0 | TABLET | |||||||
| 125356101 | 12535610 | 14 | C | CIPRALEX | ESCITALOPRAM OXALATE | 1 | Unknown | UNK | U | 0 | |||||||||
| 125356101 | 12535610 | 15 | C | DIAZEPAM. | DIAZEPAM | 1 | Unknown | 2 MG, UNK | U | 0 | 2 | MG | |||||||
| 125356101 | 12535610 | 16 | C | FINASTERIDE. | FINASTERIDE | 1 | Unknown | UNK | U | 0 | |||||||||
| 125356101 | 12535610 | 17 | C | FLUOXETINE | FLUOXETINE HYDROCHLORIDE | 1 | Unknown | UNK | U | 0 | |||||||||
| 125356101 | 12535610 | 18 | C | FLUOXETINE | FLUOXETINE HYDROCHLORIDE | 1 | Unknown | 20 MG, UNK | U | 0 | 20 | MG | |||||||
| 125356101 | 12535610 | 19 | C | CIPRAMIL /00582603/ | CITALOPRAM HYDROBROMIDE | 1 | Unknown | UNK | U | 0 | |||||||||
| 125356101 | 12535610 | 20 | C | DOSULEPIN HYDROCHLORIDE | DOTHIEPIN HYDROCHLORIDE | 1 | Unknown | UNK UNK, U | U | 0 | |||||||||
| 125356101 | 12535610 | 21 | C | MIANSERIN | MIANSERIN | 1 | Unknown | UNK UNK, UNK | U | 0 | |||||||||
| 125356101 | 12535610 | 22 | C | NICOTINE. | NICOTINE | 1 | Unknown | UNK | U | 0 | |||||||||
| 125356101 | 12535610 | 23 | C | PYRIDOXINE | PYRIDOXINE | 1 | Unknown | UNK | U | 0 | |||||||||
| 125356101 | 12535610 | 24 | C | TRAZODONE | TRAZODONE HYDROCHLORIDE | 1 | Unknown | 37.5 MG, UNK | U | 0 | 37.5 | MG | |||||||
| 125356101 | 12535610 | 25 | C | ZOLPIDEM | ZOLPIDEMOLPIDEM TARTRATE | 1 | Unknown | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125356101 | 12535610 | 1 | Depression |
| 125356101 | 12535610 | 9 | Depression |
| 125356101 | 12535610 | 10 | Depression |
| 125356101 | 12535610 | 12 | Anxiety |
| 125356101 | 12535610 | 13 | Depression |
| 125356101 | 12535610 | 14 | Product used for unknown indication |
| 125356101 | 12535610 | 15 | Product used for unknown indication |
| 125356101 | 12535610 | 16 | Alopecia |
| 125356101 | 12535610 | 17 | Product used for unknown indication |
| 125356101 | 12535610 | 19 | Product used for unknown indication |
| 125356101 | 12535610 | 20 | Product used for unknown indication |
| 125356101 | 12535610 | 21 | Product used for unknown indication |
| 125356101 | 12535610 | 22 | Product used for unknown indication |
| 125356101 | 12535610 | 23 | Premenstrual syndrome |
| 125356101 | 12535610 | 24 | Poor quality sleep |
| 125356101 | 12535610 | 25 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125356101 | 12535610 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125356101 | 12535610 | Aggression | |
| 125356101 | 12535610 | Anhedonia | |
| 125356101 | 12535610 | Anxiety | |
| 125356101 | 12535610 | Apathy | |
| 125356101 | 12535610 | Balance disorder | |
| 125356101 | 12535610 | Condition aggravated | |
| 125356101 | 12535610 | Confusional state | |
| 125356101 | 12535610 | Decreased appetite | |
| 125356101 | 12535610 | Depressed mood | |
| 125356101 | 12535610 | Derealisation | |
| 125356101 | 12535610 | Disturbance in attention | |
| 125356101 | 12535610 | Dizziness | |
| 125356101 | 12535610 | Drug withdrawal syndrome | |
| 125356101 | 12535610 | Fatigue | |
| 125356101 | 12535610 | Frustration tolerance decreased | |
| 125356101 | 12535610 | Hyperhidrosis | |
| 125356101 | 12535610 | Hypoacusis | |
| 125356101 | 12535610 | Loss of libido | |
| 125356101 | 12535610 | Memory impairment | |
| 125356101 | 12535610 | Myalgia | |
| 125356101 | 12535610 | Nightmare | |
| 125356101 | 12535610 | Palpitations | |
| 125356101 | 12535610 | Photosensitivity reaction | |
| 125356101 | 12535610 | Poor quality sleep | |
| 125356101 | 12535610 | Rash pruritic | |
| 125356101 | 12535610 | Suicidal ideation | |
| 125356101 | 12535610 | Tearfulness | |
| 125356101 | 12535610 | Thought insertion | |
| 125356101 | 12535610 | Vertigo | |
| 125356101 | 12535610 | Vision blurred | |
| 125356101 | 12535610 | Visual impairment | |
| 125356101 | 12535610 | Vitreous floaters |
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 |
|---|---|---|---|---|---|---|
| 125356101 | 12535610 | 1 | 20060223 | 0 | ||
| 125356101 | 12535610 | 2 | 20050831 | 20081118 | 0 | |
| 125356101 | 12535610 | 3 | 20030528 | 20061201 | 0 | |
| 125356101 | 12535610 | 4 | 20051007 | 20060908 | 0 | |
| 125356101 | 12535610 | 5 | 1998 | 20150405 | 0 | |
| 125356101 | 12535610 | 6 | 20040112 | 20050602 | 0 | |
| 125356101 | 12535610 | 7 | 20150203 | 20150420 | 0 | |
| 125356101 | 12535610 | 8 | 20150421 | 0 | ||
| 125356101 | 12535610 | 9 | 20070105 | 20070605 | 0 | |
| 125356101 | 12535610 | 10 | 20030521 | 0 | ||
| 125356101 | 12535610 | 11 | 20030521 | 20121231 | 0 | |
| 125356101 | 12535610 | 12 | 20030521 | 20121231 | 0 | |
| 125356101 | 12535610 | 13 | 20100915 | 20150420 | 0 | |
| 125356101 | 12535610 | 14 | 20060223 | 200607 | 0 | |
| 125356101 | 12535610 | 15 | 20051007 | 0 | ||
| 125356101 | 12535610 | 16 | 20070605 | 0 | ||
| 125356101 | 12535610 | 17 | 200806 | 0 | ||
| 125356101 | 12535610 | 18 | 19920206 | 20060421 | 0 | |
| 125356101 | 12535610 | 19 | 20060120 | 2007 | 0 | |
| 125356101 | 12535610 | 22 | 200802 | 0 | ||
| 125356101 | 12535610 | 23 | 20060120 | 0 | ||
| 125356101 | 12535610 | 24 | 20050826 | 0 |