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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124978852 | 12497885 | 2 | F | 199812 | 20160712 | 20160625 | 20160726 | EXP | GB-APOTEX-2016AP009440 | APOTEX | 40.00 | YR | F | Y | 0.00000 | 20160726 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124978852 | 12497885 | 1 | SS | PAROXETINE. | PAROXETINE | 1 | Unknown | UNK | U | U | 0 | TABLET | |||||||
| 124978852 | 12497885 | 2 | SS | PAROXETINE. | PAROXETINE | 1 | Oral | 20 MG, DAILY | U | U | 0 | 20 | MG | TABLET | QD | ||||
| 124978852 | 12497885 | 3 | SS | PAROXETINE. | PAROXETINE | 1 | Oral | 20 MG, DAILY | U | U | 0 | 20 | MG | TABLET | |||||
| 124978852 | 12497885 | 4 | SS | PAROXETINE. | PAROXETINE | 1 | Oral | 10 MG, QD (ONCE OR TWICE A WEEK) | U | U | 0 | 10 | MG | TABLET | |||||
| 124978852 | 12497885 | 5 | SS | PAROXETINE. | PAROXETINE | 1 | Oral | 5 MG, DAILY | U | U | 0 | 5 | MG | TABLET | |||||
| 124978852 | 12497885 | 6 | SS | PAROXETINE. | PAROXETINE | 1 | Oral | 5 MG, Q.O.D. | U | U | 0 | 5 | MG | TABLET | QOD | ||||
| 124978852 | 12497885 | 7 | SS | PAROXETINE. | PAROXETINE | 1 | Oral | 20 MG, QD | U | U | 0 | 20 | MG | TABLET | |||||
| 124978852 | 12497885 | 8 | SS | PAROXETINE. | PAROXETINE | 1 | Unknown | 20 MG, QD | U | U | 0 | 20 | MG | TABLET | |||||
| 124978852 | 12497885 | 9 | SS | PAROXETINE. | PAROXETINE | 1 | Oral | 10 ML | U | U | 0 | LIQUID | |||||||
| 124978852 | 12497885 | 10 | SS | PAROXETINE. | PAROXETINE | 1 | Oral | UNK | U | U | 0 | LIQUID | |||||||
| 124978852 | 12497885 | 11 | PS | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | Unknown | UNK | U | U | 20031 | TABLET | |||||||
| 124978852 | 12497885 | 12 | SS | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | Unknown | 0.25 DF, QD | U | U | 20031 | .25 | DF | TABLET | |||||
| 124978852 | 12497885 | 13 | SS | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | Unknown | 0.25 DF, Q.O.D. | U | U | 20031 | .25 | DF | TABLET | QOD | ||||
| 124978852 | 12497885 | 14 | SS | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | Unknown | UNK | U | U | 20031 | TABLET | |||||||
| 124978852 | 12497885 | 15 | SS | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | Unknown | UNK | U | U | 20031 | TABLET | |||||||
| 124978852 | 12497885 | 16 | C | ALCOHOL. | ALCOHOL | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 124978852 | 12497885 | 17 | C | STELAZINE | TRIFLUOPERAZINE HYDROCHLORIDE | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 124978852 | 12497885 | 18 | C | FLUOXETINE | FLUOXETINE HYDROCHLORIDE | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 124978852 | 12497885 | 19 | C | CITALOPRAM | CITALOPRAM HYDROBROMIDE | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 124978852 | 12497885 | 20 | C | LOFEPRAMINE | LOFEPRAMINE | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 124978852 | 12497885 | 21 | C | LOFEPRAMINE | LOFEPRAMINE | 1 | Unknown | 70 MG, DAILY | U | U | 0 | 70 | MG | ||||||
| 124978852 | 12497885 | 22 | C | ZYBAN | BUPROPION HYDROCHLORIDE | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 124978852 | 12497885 | 23 | C | NICOTINE. | NICOTINE | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 124978852 | 12497885 | 24 | C | MINOCYCLINE | MINOCYCLINEMINOCYCLINE HYDROCHLORIDE | 1 | Unknown | UNK | U | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124978852 | 12497885 | 1 | Depression |
| 124978852 | 12497885 | 9 | Depression |
| 124978852 | 12497885 | 11 | Depression |
| 124978852 | 12497885 | 16 | Product used for unknown indication |
| 124978852 | 12497885 | 17 | Product used for unknown indication |
| 124978852 | 12497885 | 18 | Product used for unknown indication |
| 124978852 | 12497885 | 19 | Product used for unknown indication |
| 124978852 | 12497885 | 20 | Product used for unknown indication |
| 124978852 | 12497885 | 22 | Smoking cessation therapy |
| 124978852 | 12497885 | 23 | Therapeutic procedure |
| 124978852 | 12497885 | 24 | Acne |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124978852 | 12497885 | HO |
| 124978852 | 12497885 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124978852 | 12497885 | Abnormal dreams | |
| 124978852 | 12497885 | Affective disorder | |
| 124978852 | 12497885 | Agitation | |
| 124978852 | 12497885 | Anhedonia | |
| 124978852 | 12497885 | Anxiety | |
| 124978852 | 12497885 | Asthenia | |
| 124978852 | 12497885 | Balance disorder | |
| 124978852 | 12497885 | Confusional state | |
| 124978852 | 12497885 | Deafness unilateral | |
| 124978852 | 12497885 | Decreased appetite | |
| 124978852 | 12497885 | Depressed mood | |
| 124978852 | 12497885 | Depression | |
| 124978852 | 12497885 | Dizziness | |
| 124978852 | 12497885 | Dry mouth | |
| 124978852 | 12497885 | Dyspnoea | |
| 124978852 | 12497885 | Eye swelling | |
| 124978852 | 12497885 | Fatigue | |
| 124978852 | 12497885 | Feeling abnormal | |
| 124978852 | 12497885 | Grief reaction | |
| 124978852 | 12497885 | Hyperhidrosis | |
| 124978852 | 12497885 | Insomnia | |
| 124978852 | 12497885 | Libido decreased | |
| 124978852 | 12497885 | Mood swings | |
| 124978852 | 12497885 | Nausea | |
| 124978852 | 12497885 | Panic attack | |
| 124978852 | 12497885 | Paraesthesia | |
| 124978852 | 12497885 | Photosensitivity reaction | |
| 124978852 | 12497885 | Post-traumatic stress disorder | |
| 124978852 | 12497885 | Restlessness | |
| 124978852 | 12497885 | Self-injurious ideation | |
| 124978852 | 12497885 | Sleep disorder | |
| 124978852 | 12497885 | Suicidal ideation | |
| 124978852 | 12497885 | Swelling face | |
| 124978852 | 12497885 | Tearfulness | |
| 124978852 | 12497885 | Treatment noncompliance | |
| 124978852 | 12497885 | Tremor | |
| 124978852 | 12497885 | Vomiting | |
| 124978852 | 12497885 | 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 |
|---|---|---|---|---|---|---|
| 124978852 | 12497885 | 1 | 19981112 | 200402 | 0 | |
| 124978852 | 12497885 | 2 | 199812 | 0 | ||
| 124978852 | 12497885 | 3 | 19990705 | 0 | ||
| 124978852 | 12497885 | 7 | 20120624 | 0 | ||
| 124978852 | 12497885 | 8 | 20020707 | 20020708 | 0 | |
| 124978852 | 12497885 | 9 | 20030901 | 0 | ||
| 124978852 | 12497885 | 10 | 20040202 | 0 | ||
| 124978852 | 12497885 | 11 | 19981112 | 0 | ||
| 124978852 | 12497885 | 14 | 200402 | 0 | ||
| 124978852 | 12497885 | 15 | 20030521 | 200603 | 0 | |
| 124978852 | 12497885 | 17 | 20030616 | 0 | ||
| 124978852 | 12497885 | 18 | 200509 | 0 | ||
| 124978852 | 12497885 | 19 | 200509 | 0 | ||
| 124978852 | 12497885 | 20 | 200509 | 0 | ||
| 124978852 | 12497885 | 21 | 200803 | 0 | ||
| 124978852 | 12497885 | 22 | 200710 | 0 | ||
| 124978852 | 12497885 | 23 | 200604 | 0 |