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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125447241 | 12544724 | 1 | I | 20031023 | 20160627 | 20160711 | 20160711 | EXP | GB-AUROBINDO-AUR-APL-2016-08580 | AUROBINDO | 35.00 | YR | M | Y | 0.00000 | 20160711 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125447241 | 12544724 | 1 | PS | Paroxetine Tablet | PAROXETINE | 1 | Unknown | UNK | U | U | 78406 | TABLET | |||||||
| 125447241 | 12544724 | 2 | SS | Paroxetine Tablet | PAROXETINE | 1 | Unknown | UNK | U | U | 78406 | TABLET | |||||||
| 125447241 | 12544724 | 3 | SS | Paroxetine Tablet | PAROXETINE | 1 | Oral | 20 MG, ONCE A DAY | U | U | 78406 | 20 | MG | TABLET | QD | ||||
| 125447241 | 12544724 | 4 | SS | Paroxetine Tablet | PAROXETINE | 1 | Oral | UNK UNK, U | U | U | 78406 | TABLET | |||||||
| 125447241 | 12544724 | 5 | SS | Paroxetine Tablet | PAROXETINE | 1 | Unknown | UNK | U | U | 78406 | TABLET | |||||||
| 125447241 | 12544724 | 6 | SS | Paroxetine Tablet | PAROXETINE | 1 | UNK | U | U | 78406 | TABLET | ||||||||
| 125447241 | 12544724 | 7 | SS | CO-DYDRAMOL | ACETAMINOPHENDIHYDROCODEINE | 1 | Unknown | U | U | 0 | |||||||||
| 125447241 | 12544724 | 8 | SS | PAROXETINE HYDROCHLORIDE. | PAROXETINE HYDROCHLORIDE | 1 | Oral | 5 ML, QD | 210.207993 | ML | U | U | 0 | 5 | ML | ORAL SOLUTION | QD | ||
| 125447241 | 12544724 | 9 | SS | PAROXETINE HYDROCHLORIDE. | PAROXETINE HYDROCHLORIDE | 1 | Oral | U | U | 0 | SUSPENSION FOR INJECTION | ||||||||
| 125447241 | 12544724 | 10 | SS | SEROXAT | PAROXETINE HYDROCHLORIDE | 1 | Oral | 20 MG, BID | 40 | MG | U | U | 0 | 20 | MG | TABLET | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125447241 | 12544724 | 1 | Depression |
| 125447241 | 12544724 | 7 | Product used for unknown indication |
| 125447241 | 12544724 | 8 | Depression |
| 125447241 | 12544724 | 9 | Depression |
| 125447241 | 12544724 | 10 | Depression |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125447241 | 12544724 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125447241 | 12544724 | Abnormal behaviour | |
| 125447241 | 12544724 | Aggression | |
| 125447241 | 12544724 | Agitation | |
| 125447241 | 12544724 | Anxiety | |
| 125447241 | 12544724 | Chest pain | |
| 125447241 | 12544724 | Disorientation | |
| 125447241 | 12544724 | Disturbance in attention | |
| 125447241 | 12544724 | Dizziness | |
| 125447241 | 12544724 | Fatigue | |
| 125447241 | 12544724 | Flat affect | |
| 125447241 | 12544724 | Headache | |
| 125447241 | 12544724 | Hyperhidrosis | |
| 125447241 | 12544724 | Impulsive behaviour | |
| 125447241 | 12544724 | Insomnia | |
| 125447241 | 12544724 | Judgement impaired | |
| 125447241 | 12544724 | Legal problem | |
| 125447241 | 12544724 | Lethargy | |
| 125447241 | 12544724 | Memory impairment | |
| 125447241 | 12544724 | Mood swings | |
| 125447241 | 12544724 | Nausea | |
| 125447241 | 12544724 | Nightmare | |
| 125447241 | 12544724 | Panic attack | |
| 125447241 | 12544724 | Paraesthesia | |
| 125447241 | 12544724 | Personality change | |
| 125447241 | 12544724 | Sleep disorder | |
| 125447241 | 12544724 | Suicidal ideation | |
| 125447241 | 12544724 | Syncope | |
| 125447241 | 12544724 | Tremor | |
| 125447241 | 12544724 | Vertigo | |
| 125447241 | 12544724 | Vomiting | |
| 125447241 | 12544724 | 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 |
|---|---|---|---|---|---|---|
| 125447241 | 12544724 | 2 | 200111 | 0 | ||
| 125447241 | 12544724 | 3 | 20030206 | 20031204 | 0 | |
| 125447241 | 12544724 | 7 | 200111 | 0 | ||
| 125447241 | 12544724 | 8 | 20031204 | 0 | ||
| 125447241 | 12544724 | 10 | 20031023 | 0 |