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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125380742 | 12538074 | 2 | F | 20010804 | 20160728 | 20160707 | 20160804 | EXP | GB-MYLANLABS-2016M1027862 | MYLAN | 0.00 | Y | 0.00000 | 20160804 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125380742 | 12538074 | 1 | PS | PAROXETINE. | PAROXETINE | 1 | Unknown | UNK | U | U | 77873 | ||||||||
| 125380742 | 12538074 | 2 | SS | PAROXETINE. | PAROXETINE | 1 | Unknown | 7 MG, QD | U | U | 77873 | 7 | MG | QD | |||||
| 125380742 | 12538074 | 3 | SS | ALCOHOL. | ALCOHOL | 1 | UNK | U | U | 0 | |||||||||
| 125380742 | 12538074 | 4 | SS | DOTHIEPIN | DOTHIEPINDOTHIEPIN HYDROCHLORIDE | 1 | UNK | U | U | 0 | |||||||||
| 125380742 | 12538074 | 5 | SS | SEROXAT | PAROXETINE HYDROCHLORIDE | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 125380742 | 12538074 | 6 | SS | SEROXAT | PAROXETINE HYDROCHLORIDE | 1 | Unknown | 2X5 ML SPOON DAILY AS DOSE DESCRIPTION | U | U | 0 | ||||||||
| 125380742 | 12538074 | 7 | SS | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | Unknown | 4 MG, UNK | U | U | 0 | 4 | MG | ||||||
| 125380742 | 12538074 | 8 | SS | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 125380742 | 12538074 | 9 | C | DIAZEPAM. | DIAZEPAM | 1 | UNK | U | 0 | ||||||||||
| 125380742 | 12538074 | 10 | C | DIAZEPAM. | DIAZEPAM | 1 | Unknown | UNK | U | 0 | |||||||||
| 125380742 | 12538074 | 11 | C | LORAZEPAM. | LORAZEPAM | 1 | UNK | U | 0 | ||||||||||
| 125380742 | 12538074 | 12 | C | PERICIAZINE | PERICIAZINE | 1 | UNK | U | 0 | ||||||||||
| 125380742 | 12538074 | 13 | C | STELAZINE | TRIFLUOPERAZINE HYDROCHLORIDE | 1 | UNK | U | 0 | ||||||||||
| 125380742 | 12538074 | 14 | C | ZOPICLONE | ZOPICLONE | 1 | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125380742 | 12538074 | 1 | Product used for unknown indication |
| 125380742 | 12538074 | 3 | Product used for unknown indication |
| 125380742 | 12538074 | 4 | Product used for unknown indication |
| 125380742 | 12538074 | 5 | Product used for unknown indication |
| 125380742 | 12538074 | 7 | Product used for unknown indication |
| 125380742 | 12538074 | 9 | Product used for unknown indication |
| 125380742 | 12538074 | 11 | Product used for unknown indication |
| 125380742 | 12538074 | 12 | Product used for unknown indication |
| 125380742 | 12538074 | 13 | Product used for unknown indication |
| 125380742 | 12538074 | 14 | Insomnia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125380742 | 12538074 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125380742 | 12538074 | Abdominal distension | |
| 125380742 | 12538074 | Abdominal pain | |
| 125380742 | 12538074 | Abnormal dreams | |
| 125380742 | 12538074 | Affect lability | |
| 125380742 | 12538074 | Aggression | |
| 125380742 | 12538074 | Agitation | |
| 125380742 | 12538074 | Anger | |
| 125380742 | 12538074 | Anxiety | |
| 125380742 | 12538074 | Appetite disorder | |
| 125380742 | 12538074 | Balance disorder | |
| 125380742 | 12538074 | Chest pain | |
| 125380742 | 12538074 | Confusional state | |
| 125380742 | 12538074 | Depressed mood | |
| 125380742 | 12538074 | Depression | |
| 125380742 | 12538074 | Diarrhoea | |
| 125380742 | 12538074 | Dissociation | |
| 125380742 | 12538074 | Disturbance in attention | |
| 125380742 | 12538074 | Drug withdrawal syndrome | |
| 125380742 | 12538074 | Dry mouth | |
| 125380742 | 12538074 | Dysarthria | |
| 125380742 | 12538074 | Dyskinesia | |
| 125380742 | 12538074 | Dyspepsia | |
| 125380742 | 12538074 | Dysphagia | |
| 125380742 | 12538074 | Emotional disorder | |
| 125380742 | 12538074 | Euphoric mood | |
| 125380742 | 12538074 | Fatigue | |
| 125380742 | 12538074 | Feeling jittery | |
| 125380742 | 12538074 | Feeling of despair | |
| 125380742 | 12538074 | Gastric disorder | |
| 125380742 | 12538074 | Hangover | |
| 125380742 | 12538074 | Headache | |
| 125380742 | 12538074 | Hyperchlorhydria | |
| 125380742 | 12538074 | Hyperhidrosis | |
| 125380742 | 12538074 | Hypersomnia | |
| 125380742 | 12538074 | Hypoaesthesia | |
| 125380742 | 12538074 | Influenza like illness | |
| 125380742 | 12538074 | Insomnia | |
| 125380742 | 12538074 | Irritability | |
| 125380742 | 12538074 | Mania | |
| 125380742 | 12538074 | Memory impairment | |
| 125380742 | 12538074 | Mood swings | |
| 125380742 | 12538074 | Muscle spasms | |
| 125380742 | 12538074 | Nausea | |
| 125380742 | 12538074 | Nervousness | |
| 125380742 | 12538074 | Night sweats | |
| 125380742 | 12538074 | Odynophagia | |
| 125380742 | 12538074 | Overdose | |
| 125380742 | 12538074 | Palpitations | |
| 125380742 | 12538074 | Panic attack | |
| 125380742 | 12538074 | Paraesthesia | |
| 125380742 | 12538074 | Paranoia | |
| 125380742 | 12538074 | Restless legs syndrome | |
| 125380742 | 12538074 | Retching | |
| 125380742 | 12538074 | Suicidal behaviour | |
| 125380742 | 12538074 | Suicidal ideation | |
| 125380742 | 12538074 | Tearfulness | |
| 125380742 | 12538074 | Tension | |
| 125380742 | 12538074 | Tremor | |
| 125380742 | 12538074 | Vision blurred | |
| 125380742 | 12538074 | Vomiting | |
| 125380742 | 12538074 | Weight fluctuation |
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 |
|---|---|---|---|---|---|---|
| 125380742 | 12538074 | 1 | 20010702 | 20060710 | 0 | |
| 125380742 | 12538074 | 2 | 20061010 | 20070315 | 0 | |
| 125380742 | 12538074 | 5 | 20061010 | 20070315 | 0 | |
| 125380742 | 12538074 | 6 | 20050621 | 20060619 | 0 | |
| 125380742 | 12538074 | 8 | 20010702 | 200706 | 0 | |
| 125380742 | 12538074 | 9 | 19991021 | 0 | ||
| 125380742 | 12538074 | 11 | 20041203 | 0 |