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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125882901 | 12588290 | 1 | I | 20160414 | 20160725 | 20160725 | PER | US-JNJFOC-20160517099 | JANSSEN | 0.00 | A | F | Y | 0.00000 | 20160725 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125882901 | 12588290 | 1 | PS | ZYRTEC | CETIRIZINE HYDROCHLORIDE | 1 | Oral | N | 19835 | FILM COATED TABLET | |||||||||
| 125882901 | 12588290 | 2 | SS | ZYRTEC | CETIRIZINE HYDROCHLORIDE | 1 | Oral | N | 19835 | FILM COATED TABLET | |||||||||
| 125882901 | 12588290 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 0 | ORAL SOLUTION | ||||||||||
| 125882901 | 12588290 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 0 | 3 | G | ORAL SOLUTION | BID | |||||||
| 125882901 | 12588290 | 5 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 0 | 4.5 | G | ORAL SOLUTION | BID | |||||||
| 125882901 | 12588290 | 6 | C | TYLENOL | ACETAMINOPHEN | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 125882901 | 12588290 | 7 | C | MODAFINIL. | MODAFINIL | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 125882901 | 12588290 | 8 | C | ALBUTEROL SULFATE. | ALBUTEROL SULFATE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 125882901 | 12588290 | 9 | C | SINGULAIR | MONTELUKAST SODIUM | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 125882901 | 12588290 | 10 | C | WARFARIN SODIUM. | WARFARIN SODIUM | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 125882901 | 12588290 | 11 | C | FLUVOXAMINE | FLUVOXAMINE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 125882901 | 12588290 | 12 | C | AMITRIPTYLINE HCL | AMITRIPTYLINE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 125882901 | 12588290 | 13 | C | ETHINYLESTRADIOL W/LEVONORGESTREL | ETHINYL ESTRADIOLLEVONORGESTREL | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 125882901 | 12588290 | 14 | C | WELLBUTRIN | BUPROPION HYDROCHLORIDE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 125882901 | 12588290 | 15 | C | ADDERALL | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 125882901 | 12588290 | 16 | C | BUSPAR | BUSPIRONE HYDROCHLORIDE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 125882901 | 12588290 | 17 | C | CALCIUM W/COLECALCIFEROL | CALCIUMCHOLECALCIFEROL | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 125882901 | 12588290 | 18 | C | FISH OIL | FISH OIL | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 125882901 | 12588290 | 19 | C | LAMICTAL | LAMOTRIGINE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 125882901 | 12588290 | 20 | C | MAGNESIUM GLUCONATE | MAGNESIUM GLUCONATE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 125882901 | 12588290 | 21 | C | NUVIGIL | ARMODAFINIL | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 125882901 | 12588290 | 22 | C | PROZAC | FLUOXETINE HYDROCHLORIDE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 125882901 | 12588290 | 23 | C | NAPHAZOLINE HYDROCHLORIDE. | NAPHAZOLINE HYDROCHLORIDE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 125882901 | 12588290 | 24 | C | ETHINYLESTRADIOL W/ETONOGESTREL | 2 | Unknown | 0 | UNSPECIFIED | |||||||||||
| 125882901 | 12588290 | 25 | C | MULTIVITAMINS | VITAMINS | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 125882901 | 12588290 | 26 | C | CYANOCOBALAMIN W/FOLIC ACID/PYRIDOXINE | 2 | Unknown | 0 | UNSPECIFIED | |||||||||||
| 125882901 | 12588290 | 27 | C | VERAPAMIL HYDROCHLORIDE. | VERAPAMIL HYDROCHLORIDE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 125882901 | 12588290 | 28 | C | CALCIUM | CALCIUM | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 125882901 | 12588290 | 29 | C | ALLERGY | UNSPECIFIED INGREDIENT | 1 | Unknown | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125882901 | 12588290 | 2 | Product used for unknown indication |
| 125882901 | 12588290 | 3 | Narcolepsy |
| 125882901 | 12588290 | 4 | Narcolepsy |
| 125882901 | 12588290 | 5 | Narcolepsy |
| 125882901 | 12588290 | 6 | Product used for unknown indication |
| 125882901 | 12588290 | 7 | Product used for unknown indication |
| 125882901 | 12588290 | 8 | Product used for unknown indication |
| 125882901 | 12588290 | 9 | Product used for unknown indication |
| 125882901 | 12588290 | 10 | Product used for unknown indication |
| 125882901 | 12588290 | 11 | Product used for unknown indication |
| 125882901 | 12588290 | 12 | Product used for unknown indication |
| 125882901 | 12588290 | 13 | Product used for unknown indication |
| 125882901 | 12588290 | 14 | Product used for unknown indication |
| 125882901 | 12588290 | 15 | Product used for unknown indication |
| 125882901 | 12588290 | 16 | Product used for unknown indication |
| 125882901 | 12588290 | 17 | Product used for unknown indication |
| 125882901 | 12588290 | 18 | Product used for unknown indication |
| 125882901 | 12588290 | 19 | Product used for unknown indication |
| 125882901 | 12588290 | 20 | Product used for unknown indication |
| 125882901 | 12588290 | 21 | Product used for unknown indication |
| 125882901 | 12588290 | 22 | Product used for unknown indication |
| 125882901 | 12588290 | 23 | Product used for unknown indication |
| 125882901 | 12588290 | 24 | Product used for unknown indication |
| 125882901 | 12588290 | 25 | Product used for unknown indication |
| 125882901 | 12588290 | 26 | Product used for unknown indication |
| 125882901 | 12588290 | 27 | Product used for unknown indication |
| 125882901 | 12588290 | 28 | Product used for unknown indication |
| 125882901 | 12588290 | 29 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125882901 | 12588290 | Sleep disorder | |
| 125882901 | 12588290 | Somnolence |
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 |
|---|---|---|---|---|---|---|
| 125882901 | 12588290 | 2 | 20160414 | 0 | ||
| 125882901 | 12588290 | 4 | 201109 | 201110 | 0 | |
| 125882901 | 12588290 | 5 | 201202 | 0 |