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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124978833 | 12497883 | 3 | F | 20040809 | 20160712 | 20160625 | 20160726 | EXP | GB-APOTEX-2016AP009433 | APOTEX | 49.00 | YR | F | Y | 0.00000 | 20160726 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124978833 | 12497883 | 1 | SS | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | Unknown | 20 MG, UNK | U | U | 0 | 20 | MG | TABLET | |||||
| 124978833 | 12497883 | 2 | PS | PAROXETINE. | PAROXETINE | 1 | Unknown | 20 MG, QD | U | U | 20031 | 20 | MG | TABLET | QD | ||||
| 124978833 | 12497883 | 3 | C | DIAZEPAM. | DIAZEPAM | 1 | UNK | U | 0 | ||||||||||
| 124978833 | 12497883 | 4 | C | TIBOLONE | TIBOLONE | 1 | 2.5 MG, 1D | U | 0 | 2.5 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124978833 | 12497883 | 1 | Panic attack |
| 124978833 | 12497883 | 2 | Product used for unknown indication |
| 124978833 | 12497883 | 3 | Phobia of flying |
| 124978833 | 12497883 | 4 | Menopause |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124978833 | 12497883 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124978833 | 12497883 | Abnormal dreams | |
| 124978833 | 12497883 | Agoraphobia | |
| 124978833 | 12497883 | Amnesia | |
| 124978833 | 12497883 | Anxiety | |
| 124978833 | 12497883 | Apathy | |
| 124978833 | 12497883 | Asthenia | |
| 124978833 | 12497883 | Aura | |
| 124978833 | 12497883 | Balance disorder | |
| 124978833 | 12497883 | Change of bowel habit | |
| 124978833 | 12497883 | Chest discomfort | |
| 124978833 | 12497883 | Condition aggravated | |
| 124978833 | 12497883 | Crying | |
| 124978833 | 12497883 | Decreased appetite | |
| 124978833 | 12497883 | Depressed mood | |
| 124978833 | 12497883 | Depression | |
| 124978833 | 12497883 | Discomfort | |
| 124978833 | 12497883 | Disorientation | |
| 124978833 | 12497883 | Disturbance in attention | |
| 124978833 | 12497883 | Dizziness | |
| 124978833 | 12497883 | Dyskinesia | |
| 124978833 | 12497883 | Ear discomfort | |
| 124978833 | 12497883 | Fatigue | |
| 124978833 | 12497883 | Fear | |
| 124978833 | 12497883 | Feeling abnormal | |
| 124978833 | 12497883 | Headache | |
| 124978833 | 12497883 | Hyperacusis | |
| 124978833 | 12497883 | Hyperhidrosis | |
| 124978833 | 12497883 | Influenza like illness | |
| 124978833 | 12497883 | Irritability | |
| 124978833 | 12497883 | Lethargy | |
| 124978833 | 12497883 | Malaise | |
| 124978833 | 12497883 | Metamorphopsia | |
| 124978833 | 12497883 | Middle insomnia | |
| 124978833 | 12497883 | Migraine | |
| 124978833 | 12497883 | Mood swings | |
| 124978833 | 12497883 | Muscle tightness | |
| 124978833 | 12497883 | Muscular weakness | |
| 124978833 | 12497883 | Neuralgia | |
| 124978833 | 12497883 | Pain in extremity | |
| 124978833 | 12497883 | Palpitations | |
| 124978833 | 12497883 | Panic attack | |
| 124978833 | 12497883 | Paraesthesia | |
| 124978833 | 12497883 | Photopsia | |
| 124978833 | 12497883 | Pruritus | |
| 124978833 | 12497883 | Psychiatric symptom | |
| 124978833 | 12497883 | Quality of life decreased | |
| 124978833 | 12497883 | Stress | |
| 124978833 | 12497883 | Suicidal ideation | |
| 124978833 | 12497883 | Tearfulness | |
| 124978833 | 12497883 | Throat tightness | |
| 124978833 | 12497883 | Tinnitus | |
| 124978833 | 12497883 | Vertigo | |
| 124978833 | 12497883 | Vision blurred | |
| 124978833 | 12497883 | Weight decreased | |
| 124978833 | 12497883 | Weight increased | |
| 124978833 | 12497883 | 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 |
|---|---|---|---|---|---|---|
| 124978833 | 12497883 | 1 | 199504 | 2005 | 0 | |
| 124978833 | 12497883 | 2 | 19950403 | 0 | ||
| 124978833 | 12497883 | 3 | 19810731 | 0 | ||
| 124978833 | 12497883 | 4 | 20040809 | 0 |