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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125484062 | 12548406 | 2 | F | 2000 | 20160719 | 20160712 | 20160801 | EXP | GB-AUROBINDO-AUR-APL-2016-08601 | AUROBINDO | 35.00 | YR | M | Y | 0.00000 | 20160801 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125484062 | 12548406 | 1 | PS | Paroxetine Tablet | PAROXETINE | 1 | Oral | 20 MG, ONCE A DAY | 900 | MG | U | 78406 | 20 | MG | TABLET | QD | |||
| 125484062 | 12548406 | 2 | SS | Paroxetine Tablet | PAROXETINE | 1 | Unknown | 40 MG, ONCE A DAY | 900 | MG | U | 78406 | 40 | MG | TABLET | QD | |||
| 125484062 | 12548406 | 3 | SS | Paroxetine Tablet | PAROXETINE | 1 | Oral | 20 MG, TWO TIMES A DAY | 900 | MG | U | 78406 | 20 | MG | TABLET | BID | |||
| 125484062 | 12548406 | 4 | SS | PAROXETINE HYDROCHLORIDE. | PAROXETINE HYDROCHLORIDE | 1 | Oral | 5 ML, ONCE A DAY | 4544.79199 | ML | U | 0 | 5 | ML | ORAL SOLUTION | QD | |||
| 125484062 | 12548406 | 5 | SS | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | Unknown | 40 MG, ONCE A DAY | 1800 | MG | U | 0 | 40 | MG | TABLET | QD | |||
| 125484062 | 12548406 | 6 | SS | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | Unknown | 30 MG, ONCE A DAY | 1800 | MG | U | 0 | 30 | MG | TABLET | QD | |||
| 125484062 | 12548406 | 7 | SS | SEROXAT | PAROXETINE HYDROCHLORIDE | 1 | Unknown | 40 MG, 1D | 7120 | MG | U | 0 | 40 | MG | ORAL SOLUTION | QD | |||
| 125484062 | 12548406 | 8 | SS | SEROXAT | PAROXETINE HYDROCHLORIDE | 1 | Unknown | 30 MG, 1D | 7120 | MG | U | 0 | 30 | MG | ORAL SOLUTION | QD | |||
| 125484062 | 12548406 | 9 | C | CIPRAMIL /00582602/ | CITALOPRAM HYDROBROMIDE | 1 | Unknown | U | 0 | ||||||||||
| 125484062 | 12548406 | 10 | C | EFFEXOR | VENLAFAXINE HYDROCHLORIDE | 1 | Unknown | U | 0 | ||||||||||
| 125484062 | 12548406 | 11 | C | ETHANOL | ALCOHOL | 1 | Unknown | U | 0 | ||||||||||
| 125484062 | 12548406 | 12 | C | PROZAC | FLUOXETINE HYDROCHLORIDE | 1 | Unknown | U | 0 | ||||||||||
| 125484062 | 12548406 | 13 | C | VENLAFAXINE | VENLAFAXINE HYDROCHLORIDE | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125484062 | 12548406 | 1 | Product used for unknown indication |
| 125484062 | 12548406 | 4 | Depression |
| 125484062 | 12548406 | 5 | Product used for unknown indication |
| 125484062 | 12548406 | 7 | Depression |
| 125484062 | 12548406 | 8 | Anxiety |
| 125484062 | 12548406 | 9 | Product used for unknown indication |
| 125484062 | 12548406 | 10 | Product used for unknown indication |
| 125484062 | 12548406 | 11 | Product used for unknown indication |
| 125484062 | 12548406 | 12 | Product used for unknown indication |
| 125484062 | 12548406 | 13 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125484062 | 12548406 | HO |
| 125484062 | 12548406 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125484062 | 12548406 | Abnormal dreams | |
| 125484062 | 12548406 | Aggression | |
| 125484062 | 12548406 | Agitation | |
| 125484062 | 12548406 | Agoraphobia | |
| 125484062 | 12548406 | Alcohol abuse | |
| 125484062 | 12548406 | Amnesia | |
| 125484062 | 12548406 | Anxiety | |
| 125484062 | 12548406 | Balance disorder | |
| 125484062 | 12548406 | Dependence | |
| 125484062 | 12548406 | Depression | |
| 125484062 | 12548406 | Disturbance in attention | |
| 125484062 | 12548406 | Dizziness | |
| 125484062 | 12548406 | Ejaculation failure | |
| 125484062 | 12548406 | Electric shock | |
| 125484062 | 12548406 | Frustration tolerance decreased | |
| 125484062 | 12548406 | Gait disturbance | |
| 125484062 | 12548406 | Hyperacusis | |
| 125484062 | 12548406 | Hyperhidrosis | |
| 125484062 | 12548406 | Impatience | |
| 125484062 | 12548406 | Insomnia | |
| 125484062 | 12548406 | Irritability | |
| 125484062 | 12548406 | Nausea | |
| 125484062 | 12548406 | Nightmare | |
| 125484062 | 12548406 | Overdose | |
| 125484062 | 12548406 | Paraesthesia | |
| 125484062 | 12548406 | Paranoia | |
| 125484062 | 12548406 | Parasomnia | |
| 125484062 | 12548406 | Sleep disorder | |
| 125484062 | 12548406 | Social avoidant behaviour | |
| 125484062 | 12548406 | Somnolence | |
| 125484062 | 12548406 | Suicide attempt | |
| 125484062 | 12548406 | Tremor | |
| 125484062 | 12548406 | 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 |
|---|---|---|---|---|---|---|
| 125484062 | 12548406 | 1 | 19991117 | 0 | ||
| 125484062 | 12548406 | 2 | 20000711 | 20020714 | 0 | |
| 125484062 | 12548406 | 3 | 19991202 | 20030731 | 0 | |
| 125484062 | 12548406 | 4 | 20020628 | 20040105 | 0 | |
| 125484062 | 12548406 | 5 | 19991117 | 20040609 | 0 | |
| 125484062 | 12548406 | 6 | 20020124 | 0 | ||
| 125484062 | 12548406 | 7 | 19991117 | 20040609 | 0 | |
| 125484062 | 12548406 | 8 | 20020124 | 0 | ||
| 125484062 | 12548406 | 10 | 20010910 | 0 | ||
| 125484062 | 12548406 | 12 | 20001101 | 0 |