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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126044531 | 12604453 | 1 | I | 2015 | 20160718 | 20160728 | 20160728 | EXP | US-TEVA-678697USA | TEVA | 0.00 | F | Y | 88.53000 | KG | 20160728 | CN | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126044531 | 12604453 | 1 | PS | AMPHETAMINE W/DEXTROAMPHETAMINE | AMPHETAMINE SULFATEDEXTROAMPHETAMINE | 1 | 60 MILLIGRAM DAILY; | U | 40422 | 30 | MG | BID | |||||||
| 126044531 | 12604453 | 2 | SS | GRALISE | GABAPENTIN | 1 | TITRATED UP TO 1800MG QD | U | MTFT7591 | 0 | |||||||||
| 126044531 | 12604453 | 3 | SS | GRALISE | GABAPENTIN | 1 | QD | U | MTFT7591 | 0 | 1200 | MG | |||||||
| 126044531 | 12604453 | 4 | SS | GRALISE | GABAPENTIN | 1 | TITRATED GRADUALLY | U | MTFT7591 | 0 | |||||||||
| 126044531 | 12604453 | 5 | SS | GRALISE | GABAPENTIN | 1 | WITH EVENING MEAL | U | MTFT7591 | 0 | 1800 | MG | |||||||
| 126044531 | 12604453 | 6 | SS | PERCOCET | ACETAMINOPHENOXYCODONE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 126044531 | 12604453 | 7 | SS | PERCOCET | ACETAMINOPHENOXYCODONE HYDROCHLORIDE | 1 | TITRATED DOWN TO 5 MG | U | 0 | ||||||||||
| 126044531 | 12604453 | 8 | C | NICOTINE TRANSDERMAL SYSTEM | NICOTINE | 1 | 0 | ||||||||||||
| 126044531 | 12604453 | 9 | C | PROPRANOLOL | PROPRANOLOLPROPRANOLOL HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 126044531 | 12604453 | 10 | C | CYCLOBENZAPRINE | CYCLOBENZAPRINE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126044531 | 12604453 | 1 | Attention deficit/hyperactivity disorder |
| 126044531 | 12604453 | 2 | Pain |
| 126044531 | 12604453 | 6 | Pain |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126044531 | 12604453 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126044531 | 12604453 | Abdominal distension | |
| 126044531 | 12604453 | Amnesia | |
| 126044531 | 12604453 | Blindness | |
| 126044531 | 12604453 | Cough | |
| 126044531 | 12604453 | Depressed mood | |
| 126044531 | 12604453 | Drug dose omission | |
| 126044531 | 12604453 | Drug ineffective for unapproved indication | |
| 126044531 | 12604453 | Drug prescribing error | |
| 126044531 | 12604453 | Dysuria | |
| 126044531 | 12604453 | Euphoric mood | |
| 126044531 | 12604453 | Fatigue | |
| 126044531 | 12604453 | Feeling abnormal | |
| 126044531 | 12604453 | Formication | |
| 126044531 | 12604453 | Headache | |
| 126044531 | 12604453 | Hypersomnia | |
| 126044531 | 12604453 | Inappropriate schedule of drug administration | |
| 126044531 | 12604453 | Incontinence | |
| 126044531 | 12604453 | Incorrect dose administered | |
| 126044531 | 12604453 | Malaise | |
| 126044531 | 12604453 | Mental fatigue | |
| 126044531 | 12604453 | Nausea | |
| 126044531 | 12604453 | Off label use | |
| 126044531 | 12604453 | Pain | |
| 126044531 | 12604453 | Peripheral swelling | |
| 126044531 | 12604453 | Sciatica | |
| 126044531 | 12604453 | Somnolence | |
| 126044531 | 12604453 | Urine odour abnormal | |
| 126044531 | 12604453 | Weight increased | |
| 126044531 | 12604453 | 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 |
|---|---|---|---|---|---|---|
| 126044531 | 12604453 | 2 | 2015 | 2015 | 0 | |
| 126044531 | 12604453 | 3 | 2015 | 2015 | 0 | |
| 126044531 | 12604453 | 4 | 2015 | 20150325 | 0 | |
| 126044531 | 12604453 | 5 | 20160330 | 0 | ||
| 126044531 | 12604453 | 6 | 2015 | 0 | ||
| 126044531 | 12604453 | 7 | 2015 | 201602 | 0 | |
| 126044531 | 12604453 | 9 | 2015 | 0 |