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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125483801 | 12548380 | 1 | I | 20010517 | 20160628 | 20160712 | 20160712 | EXP | GB-AUROBINDO-AUR-APL-2016-08593 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125483801 | 12548380 | 1 | PS | Paroxetine tablets 20 mg | PAROXETINE HYDROCHLORIDE | 1 | Unknown | UNK | 4920.83301 | MG | U | U | 78406 | TABLET | |||||
| 125483801 | 12548380 | 2 | SS | Paroxetine tablets 20 mg | PAROXETINE HYDROCHLORIDE | 1 | Oral | 40 MG, QD | 4920.83301 | MG | U | U | 78406 | 40 | MG | TABLET | QD | ||
| 125483801 | 12548380 | 3 | SS | Paroxetine tablets 20 mg | PAROXETINE HYDROCHLORIDE | 1 | Oral | 20 MG, QD | 4920.83301 | MG | U | U | 78406 | 20 | MG | TABLET | QD | ||
| 125483801 | 12548380 | 4 | SS | PAROXETINE HYDROCHLORIDE. | PAROXETINE HYDROCHLORIDE | 1 | Oral | 2 ML, UNK | U | U | 0 | 2 | ML | SUSPENSION FOR INJECTION | |||||
| 125483801 | 12548380 | 5 | SS | PAROXETINE HYDROCHLORIDE. | PAROXETINE HYDROCHLORIDE | 1 | UNK | U | U | 0 | SUSPENSION FOR INJECTION | ||||||||
| 125483801 | 12548380 | 6 | SS | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | Oral | 20 MG, BID | 640 | MG | U | U | 0 | 20 | MG | TABLET | BID | ||
| 125483801 | 12548380 | 7 | SS | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | Oral | 30 MG, QD | 640 | MG | U | U | 0 | 30 | MG | TABLET | QD | ||
| 125483801 | 12548380 | 8 | C | BUSPIRONE | BUSPIRONE HYDROCHLORIDE | 1 | Unknown | UNK | U | 0 | |||||||||
| 125483801 | 12548380 | 9 | C | DIAZEPAM. | DIAZEPAM | 1 | Unknown | 2 MG, TWO TIMES A DAY | 16379.833 | MG | U | 0 | 2 | MG | BID | ||||
| 125483801 | 12548380 | 10 | C | DOMPERIDONE | DOMPERIDONE | 1 | Unknown | UNK | U | 0 | |||||||||
| 125483801 | 12548380 | 11 | C | DOSULEPIN HYDROCHLORIDE | DOTHIEPIN HYDROCHLORIDE | 1 | Unknown | UNK | U | 0 | |||||||||
| 125483801 | 12548380 | 12 | C | EFFEXOR | VENLAFAXINE HYDROCHLORIDE | 1 | Unknown | UNK | U | 0 | |||||||||
| 125483801 | 12548380 | 13 | C | LOSARTAN. | LOSARTAN | 1 | Unknown | UNK | U | 0 | |||||||||
| 125483801 | 12548380 | 14 | C | NIQUITIN /01033301/ | 2 | Unknown | UNK | U | 0 | ||||||||||
| 125483801 | 12548380 | 15 | C | PROPRANOLOL | PROPRANOLOLPROPRANOLOL HYDROCHLORIDE | 1 | Unknown | 10 MG, FOUR TIMES/DAY | U | 0 | 10 | MG | QID | ||||||
| 125483801 | 12548380 | 16 | C | STELAZINE | TRIFLUOPERAZINE HYDROCHLORIDE | 1 | Unknown | UNK | U | 0 | |||||||||
| 125483801 | 12548380 | 17 | C | ZOPICLONE | ZOPICLONE | 1 | Unknown | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125483801 | 12548380 | 1 | Anxiety |
| 125483801 | 12548380 | 4 | Depression |
| 125483801 | 12548380 | 5 | Anxiety |
| 125483801 | 12548380 | 6 | Depression |
| 125483801 | 12548380 | 7 | Anxiety |
| 125483801 | 12548380 | 8 | Product used for unknown indication |
| 125483801 | 12548380 | 9 | Product used for unknown indication |
| 125483801 | 12548380 | 10 | Product used for unknown indication |
| 125483801 | 12548380 | 11 | Product used for unknown indication |
| 125483801 | 12548380 | 12 | Product used for unknown indication |
| 125483801 | 12548380 | 13 | Product used for unknown indication |
| 125483801 | 12548380 | 14 | Ex-tobacco user |
| 125483801 | 12548380 | 15 | Product used for unknown indication |
| 125483801 | 12548380 | 16 | Product used for unknown indication |
| 125483801 | 12548380 | 17 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125483801 | 12548380 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125483801 | 12548380 | Abnormal dreams | |
| 125483801 | 12548380 | Anxiety | |
| 125483801 | 12548380 | Apathy | |
| 125483801 | 12548380 | Chills | |
| 125483801 | 12548380 | Communication disorder | |
| 125483801 | 12548380 | Decreased appetite | |
| 125483801 | 12548380 | Depressed mood | |
| 125483801 | 12548380 | Depression | |
| 125483801 | 12548380 | Dyskinesia | |
| 125483801 | 12548380 | Dyspnoea | |
| 125483801 | 12548380 | Fatigue | |
| 125483801 | 12548380 | Lethargy | |
| 125483801 | 12548380 | Nausea | |
| 125483801 | 12548380 | Nightmare | |
| 125483801 | 12548380 | Paraesthesia | |
| 125483801 | 12548380 | Restlessness | |
| 125483801 | 12548380 | Sleep disorder | |
| 125483801 | 12548380 | Suicidal ideation | |
| 125483801 | 12548380 | Tremor | |
| 125483801 | 12548380 | Weight decreased | |
| 125483801 | 12548380 | 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 |
|---|---|---|---|---|---|---|
| 125483801 | 12548380 | 1 | 20010417 | 0 | ||
| 125483801 | 12548380 | 2 | 20010709 | 0 | ||
| 125483801 | 12548380 | 3 | 20020118 | 20030626 | 0 | |
| 125483801 | 12548380 | 6 | 20010501 | 0 | ||
| 125483801 | 12548380 | 7 | 20020115 | 0 | ||
| 125483801 | 12548380 | 8 | 20050210 | 200505 | 0 | |
| 125483801 | 12548380 | 9 | 19900301 | 20051219 | 0 | |
| 125483801 | 12548380 | 11 | 200604 | 0 | ||
| 125483801 | 12548380 | 12 | 20050401 | 0 | ||
| 125483801 | 12548380 | 13 | 200508 | 0 | ||
| 125483801 | 12548380 | 14 | 20050124 | 200502 | 0 | |
| 125483801 | 12548380 | 15 | 1990 | 0 | ||
| 125483801 | 12548380 | 16 | 1994 | 0 | ||
| 125483801 | 12548380 | 17 | 1996 | 200508 | 0 |