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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125380931 | 12538093 | 1 | I | 20010517 | 20160628 | 20160707 | 20160707 | EXP | GB-MYLANLABS-2016M1027867 | MYLAN | 0.00 | Y | 0.00000 | 20160707 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125380931 | 12538093 | 1 | PS | PAROXETINE MYLAN | PAROXETINE | 1 | Oral | 20 MG, QD (20 MG, QD) | 4920.83301 | MG | U | U | 77873 | 20 | MG | QD | |||
| 125380931 | 12538093 | 2 | SS | PAROXETINE MYLAN | PAROXETINE | 1 | Oral | 40 MG, QD (40 MG, QD) | 4920.83301 | MG | U | U | 77873 | 40 | MG | QD | |||
| 125380931 | 12538093 | 3 | SS | PAROXETINE MYLAN | PAROXETINE | 1 | Unknown | UNK (UNK) | 4920.83301 | MG | U | U | 77873 | ||||||
| 125380931 | 12538093 | 4 | SS | PAROXETINE HYDROCHLORIDE. | PAROXETINE HYDROCHLORIDE | 1 | Oral | 2 ML, UNK (2 ML, UNK) | U | U | 0 | 2 | ML | ||||||
| 125380931 | 12538093 | 5 | SS | PAROXETINE HYDROCHLORIDE. | PAROXETINE HYDROCHLORIDE | 1 | U | U | 0 | ||||||||||
| 125380931 | 12538093 | 6 | SS | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | Oral | 20 MG, BID (20 MG, BID) | 640 | MG | U | U | 0 | 20 | MG | BID | |||
| 125380931 | 12538093 | 7 | SS | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | Oral | 30 MG, QD (30 MG, QD) | 640 | MG | U | U | 0 | 30 | MG | QD | |||
| 125380931 | 12538093 | 8 | C | BUSPIRONE | BUSPIRONE HYDROCHLORIDE | 1 | UNK (UNK) | U | 0 | ||||||||||
| 125380931 | 12538093 | 9 | C | DIAZEPAM. | DIAZEPAM | 1 | 2 MG, BID (2 MG, UNK) | 16379.833 | MG | U | 0 | 2 | MG | BID | |||||
| 125380931 | 12538093 | 10 | C | DOMPERIDONE | DOMPERIDONE | 1 | UNK (UNK) | U | 0 | ||||||||||
| 125380931 | 12538093 | 11 | C | DOSULEPIN HYDROCHLORIDE | DOTHIEPIN HYDROCHLORIDE | 1 | UNK (UNK) | U | 0 | ||||||||||
| 125380931 | 12538093 | 12 | C | EFFEXOR | VENLAFAXINE HYDROCHLORIDE | 1 | UNK (UNK) | U | 0 | ||||||||||
| 125380931 | 12538093 | 13 | C | LOSARTAN. | LOSARTAN | 1 | UNK (UNK) | U | 0 | ||||||||||
| 125380931 | 12538093 | 14 | C | NIQUITIN /01033301/ | 2 | UNK | U | 0 | |||||||||||
| 125380931 | 12538093 | 15 | C | PROPRANOLOL | PROPRANOLOLPROPRANOLOL HYDROCHLORIDE | 1 | 10 MG, QID (10 MG, UNK) | U | 0 | 10 | MG | QID | |||||||
| 125380931 | 12538093 | 16 | C | STELAZINE | TRIFLUOPERAZINE HYDROCHLORIDE | 1 | UNK (UNK) | U | 0 | ||||||||||
| 125380931 | 12538093 | 17 | C | ZOPICLONE | ZOPICLONE | 1 | UNK (UNK) | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125380931 | 12538093 | 1 | Anxiety |
| 125380931 | 12538093 | 2 | Depression |
| 125380931 | 12538093 | 4 | Depression |
| 125380931 | 12538093 | 5 | Anxiety |
| 125380931 | 12538093 | 6 | Depression |
| 125380931 | 12538093 | 7 | Anxiety |
| 125380931 | 12538093 | 8 | Product used for unknown indication |
| 125380931 | 12538093 | 9 | Product used for unknown indication |
| 125380931 | 12538093 | 10 | Product used for unknown indication |
| 125380931 | 12538093 | 11 | Product used for unknown indication |
| 125380931 | 12538093 | 12 | Product used for unknown indication |
| 125380931 | 12538093 | 13 | Product used for unknown indication |
| 125380931 | 12538093 | 14 | Ex-tobacco user |
| 125380931 | 12538093 | 15 | Product used for unknown indication |
| 125380931 | 12538093 | 16 | Product used for unknown indication |
| 125380931 | 12538093 | 17 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125380931 | 12538093 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125380931 | 12538093 | Abnormal dreams | |
| 125380931 | 12538093 | Anxiety | |
| 125380931 | 12538093 | Apathy | |
| 125380931 | 12538093 | Chills | |
| 125380931 | 12538093 | Communication disorder | |
| 125380931 | 12538093 | Decreased appetite | |
| 125380931 | 12538093 | Depressed mood | |
| 125380931 | 12538093 | Depression | |
| 125380931 | 12538093 | Dyskinesia | |
| 125380931 | 12538093 | Dyspnoea | |
| 125380931 | 12538093 | Fatigue | |
| 125380931 | 12538093 | Lethargy | |
| 125380931 | 12538093 | Nausea | |
| 125380931 | 12538093 | Nightmare | |
| 125380931 | 12538093 | Paraesthesia | |
| 125380931 | 12538093 | Restlessness | |
| 125380931 | 12538093 | Sleep disorder | |
| 125380931 | 12538093 | Suicidal ideation | |
| 125380931 | 12538093 | Tremor | |
| 125380931 | 12538093 | Weight decreased | |
| 125380931 | 12538093 | 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 |
|---|---|---|---|---|---|---|
| 125380931 | 12538093 | 1 | 20020118 | 20030626 | 0 | |
| 125380931 | 12538093 | 2 | 20010709 | 0 | ||
| 125380931 | 12538093 | 3 | 20010417 | 0 | ||
| 125380931 | 12538093 | 6 | 20010501 | 0 | ||
| 125380931 | 12538093 | 7 | 20020115 | 0 | ||
| 125380931 | 12538093 | 8 | 20050210 | 200505 | 0 | |
| 125380931 | 12538093 | 9 | 19900301 | 20051219 | 0 | |
| 125380931 | 12538093 | 11 | 200604 | 0 | ||
| 125380931 | 12538093 | 12 | 20050401 | 0 | ||
| 125380931 | 12538093 | 13 | 200508 | 0 | ||
| 125380931 | 12538093 | 14 | 20050124 | 200502 | 0 | |
| 125380931 | 12538093 | 15 | 1990 | 0 | ||
| 125380931 | 12538093 | 16 | 1994 | 0 | ||
| 125380931 | 12538093 | 17 | 1996 | 200508 | 0 |