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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125024822 | 12502482 | 2 | F | 20010302 | 20160629 | 20160627 | 20160715 | EXP | GB-APOTEX-2016AP009480 | APOTEX | 46.00 | YR | F | Y | 0.00000 | 20160715 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125024822 | 12502482 | 1 | PS | PAROXETINE. | PAROXETINE | 1 | Oral | 20 MG, QD | U | U | 20031 | 20 | MG | TABLET | |||||
| 125024822 | 12502482 | 2 | SS | PAROXETINE. | PAROXETINE | 1 | Oral | 30 MG, QD | U | U | 20031 | 30 | MG | TABLET | |||||
| 125024822 | 12502482 | 3 | SS | PAROXETINE. | PAROXETINE | 1 | Unknown | 5 MG, QD | U | U | 20031 | 5 | MG | TABLET | |||||
| 125024822 | 12502482 | 4 | SS | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | Unknown | UNK | U | U | 0 | TABLET | |||||||
| 125024822 | 12502482 | 5 | SS | PAROXETINE. | PAROXETINE | 1 | Oral | 20 MG/10ML, 2X5ML SPOON DAILY | U | U | 0 | 20 | DF | ORAL SOLUTION | QD | ||||
| 125024822 | 12502482 | 6 | C | THYROXINE | LEVOTHYROXINE | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 125024822 | 12502482 | 7 | C | PROTHIADEN | DOTHIEPIN HYDROCHLORIDE | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 125024822 | 12502482 | 8 | C | DIAZEPAM. | DIAZEPAM | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 125024822 | 12502482 | 9 | C | CYCLOGEST | PROGESTERONE | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 125024822 | 12502482 | 10 | C | ESTRADERM | ESTRADIOL | 1 | Unknown | UNK | U | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125024822 | 12502482 | 1 | Depression |
| 125024822 | 12502482 | 4 | Product used for unknown indication |
| 125024822 | 12502482 | 5 | Depression |
| 125024822 | 12502482 | 6 | Hypothyroidism |
| 125024822 | 12502482 | 7 | Product used for unknown indication |
| 125024822 | 12502482 | 8 | Product used for unknown indication |
| 125024822 | 12502482 | 9 | Product used for unknown indication |
| 125024822 | 12502482 | 10 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125024822 | 12502482 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125024822 | 12502482 | Anger | |
| 125024822 | 12502482 | Anxiety | |
| 125024822 | 12502482 | Chronic fatigue syndrome | |
| 125024822 | 12502482 | Crying | |
| 125024822 | 12502482 | Depression | |
| 125024822 | 12502482 | Disturbance in attention | |
| 125024822 | 12502482 | Dizziness | |
| 125024822 | 12502482 | Dysarthria | |
| 125024822 | 12502482 | Emotional distress | |
| 125024822 | 12502482 | Fatigue | |
| 125024822 | 12502482 | Fear | |
| 125024822 | 12502482 | Gait disturbance | |
| 125024822 | 12502482 | Headache | |
| 125024822 | 12502482 | Hyperhidrosis | |
| 125024822 | 12502482 | Ill-defined disorder | |
| 125024822 | 12502482 | Insomnia | |
| 125024822 | 12502482 | Irritability | |
| 125024822 | 12502482 | Mental impairment | |
| 125024822 | 12502482 | Mood swings | |
| 125024822 | 12502482 | Muscle contractions involuntary | |
| 125024822 | 12502482 | Nausea | |
| 125024822 | 12502482 | Night sweats | |
| 125024822 | 12502482 | Nightmare | |
| 125024822 | 12502482 | Pain in extremity | |
| 125024822 | 12502482 | Panic attack | |
| 125024822 | 12502482 | Paraesthesia | |
| 125024822 | 12502482 | Sleep disorder | |
| 125024822 | 12502482 | Somnolence | |
| 125024822 | 12502482 | Suicidal ideation | |
| 125024822 | 12502482 | Tearfulness | |
| 125024822 | 12502482 | Tinnitus | |
| 125024822 | 12502482 | Vertigo | |
| 125024822 | 12502482 | Vision blurred | |
| 125024822 | 12502482 | Weight decreased | |
| 125024822 | 12502482 | Weight increased | |
| 125024822 | 12502482 | 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 |
|---|---|---|---|---|---|---|
| 125024822 | 12502482 | 1 | 19990224 | 20020411 | 0 | |
| 125024822 | 12502482 | 2 | 19990319 | 20011213 | 0 | |
| 125024822 | 12502482 | 3 | 20020610 | 0 | ||
| 125024822 | 12502482 | 4 | 1999 | 2000 | 0 | |
| 125024822 | 12502482 | 5 | 20020429 | 0 | ||
| 125024822 | 12502482 | 7 | 19881201 | 0 | ||
| 125024822 | 12502482 | 8 | 19900316 | 0 |