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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125483781 | 12548378 | 1 | I | 200404 | 20160628 | 20160712 | 20160712 | EXP | GB-AUROBINDO-AUR-APL-2016-08596 | AUROBINDO | 0.00 | F | Y | 0.00000 | 20160712 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125483781 | 12548378 | 1 | PS | Paroxetine tablets 20 mg | PAROXETINE HYDROCHLORIDE | 1 | Unknown | 20 MG, UNK | U | U | 78406 | 20 | MG | TABLET | |||||
| 125483781 | 12548378 | 2 | SS | PAROXETINE HYDROCHLORIDE. | PAROXETINE HYDROCHLORIDE | 1 | Oral | 10MG/5ML | U | U | 0 | ORAL SOLUTION | |||||||
| 125483781 | 12548378 | 3 | SS | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | Unknown | 20 MG, QD | U | U | 0 | 20 | MG | TABLET | QD | ||||
| 125483781 | 12548378 | 4 | C | CITALOPRAM | CITALOPRAM HYDROBROMIDE | 1 | Unknown | UNK | U | 0 | |||||||||
| 125483781 | 12548378 | 5 | C | LEVOTHYROXINE SODIUM. | LEVOTHYROXINE SODIUM | 1 | Unknown | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125483781 | 12548378 | 1 | Product used for unknown indication |
| 125483781 | 12548378 | 2 | Product used for unknown indication |
| 125483781 | 12548378 | 3 | Perinatal depression |
| 125483781 | 12548378 | 4 | Depression |
| 125483781 | 12548378 | 5 | Hypothyroidism |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125483781 | 12548378 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125483781 | 12548378 | Abnormal dreams | |
| 125483781 | 12548378 | Aggression | |
| 125483781 | 12548378 | Agitation | |
| 125483781 | 12548378 | Alopecia | |
| 125483781 | 12548378 | Anxiety | |
| 125483781 | 12548378 | Arthralgia | |
| 125483781 | 12548378 | Asthenia | |
| 125483781 | 12548378 | Chest discomfort | |
| 125483781 | 12548378 | Confusional state | |
| 125483781 | 12548378 | Disturbance in attention | |
| 125483781 | 12548378 | Drug dependence | |
| 125483781 | 12548378 | Drug withdrawal syndrome | |
| 125483781 | 12548378 | Dyspnoea | |
| 125483781 | 12548378 | Fatigue | |
| 125483781 | 12548378 | Flushing | |
| 125483781 | 12548378 | Headache | |
| 125483781 | 12548378 | Hyperhidrosis | |
| 125483781 | 12548378 | Hypoacusis | |
| 125483781 | 12548378 | Hypoaesthesia | |
| 125483781 | 12548378 | Hypomania | |
| 125483781 | 12548378 | Influenza | |
| 125483781 | 12548378 | Irritability | |
| 125483781 | 12548378 | Lethargy | |
| 125483781 | 12548378 | Loss of libido | |
| 125483781 | 12548378 | Mood altered | |
| 125483781 | 12548378 | Muscle spasms | |
| 125483781 | 12548378 | Myalgia | |
| 125483781 | 12548378 | Nausea | |
| 125483781 | 12548378 | Nightmare | |
| 125483781 | 12548378 | Pain | |
| 125483781 | 12548378 | Palpitations | |
| 125483781 | 12548378 | Paraesthesia | |
| 125483781 | 12548378 | Personality change | |
| 125483781 | 12548378 | Phobia | |
| 125483781 | 12548378 | Sexual inhibition | |
| 125483781 | 12548378 | Sleep disorder | |
| 125483781 | 12548378 | Suicidal ideation | |
| 125483781 | 12548378 | Tinnitus | |
| 125483781 | 12548378 | Weight decreased | |
| 125483781 | 12548378 | Weight increased |
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 |
|---|---|---|---|---|---|---|
| 125483781 | 12548378 | 1 | 19970910 | 0 | ||
| 125483781 | 12548378 | 3 | 1991 | 20010205 | 0 | |
| 125483781 | 12548378 | 4 | 200610 | 200610 | 0 | |
| 125483781 | 12548378 | 5 | 2005 | 0 |