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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127777371 | 12777737 | 1 | I | 20160606 | 20160924 | 20160924 | PER | US-JAZZ-2016-US-010480 | JAZZ | 0.00 | F | Y | 0.00000 | 20160924 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127777371 | 12777737 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | 21196 | 2.25 | G | ORAL SOLUTION | |||||||
| 127777371 | 12777737 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.75 G, BID | 21196 | 3.75 | G | ORAL SOLUTION | |||||||
| 127777371 | 12777737 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | 21196 | 2.25 | G | ORAL SOLUTION | |||||||
| 127777371 | 12777737 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | 21196 | ORAL SOLUTION | |||||||||
| 127777371 | 12777737 | 5 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.75 G, BID | 21196 | 3.75 | G | ORAL SOLUTION | |||||||
| 127777371 | 12777737 | 6 | SS | HYDROXYZINE | HYDROXYZINEHYDROXYZINE HYDROCHLORIDE | 1 | UNK | 0 | TABLET | ||||||||||
| 127777371 | 12777737 | 7 | SS | Calcium +D | CALCIUMVITAMIN D | 1 | UNK | U | 0 | ||||||||||
| 127777371 | 12777737 | 8 | C | ADDERALL XR | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | U | 0 | |||||||||||
| 127777371 | 12777737 | 9 | C | Prenatal | VITAMINS | 1 | U | 0 | |||||||||||
| 127777371 | 12777737 | 10 | C | Acetaminophen with codeine 3 | ACETAMINOPHENCODEINE PHOSPHATE | 1 | U | 0 | |||||||||||
| 127777371 | 12777737 | 11 | C | Fluoxetine hcl | FLUOXETINE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 127777371 | 12777737 | 12 | C | FOLIC ACID. | FOLIC ACID | 1 | U | 0 | |||||||||||
| 127777371 | 12777737 | 13 | C | Hydroxyzine hcl | HYDROXYZINE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 127777371 | 12777737 | 14 | C | TOPAMAX | TOPIRAMATE | 1 | U | 0 | |||||||||||
| 127777371 | 12777737 | 15 | C | ADDERALL | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | U | 0 | |||||||||||
| 127777371 | 12777737 | 16 | C | CLINDAMYCIN PHOSPHATE. | CLINDAMYCIN PHOSPHATE | 1 | U | 0 | |||||||||||
| 127777371 | 12777737 | 17 | C | MOMETASONE FUROATE. | MOMETASONE FUROATE | 1 | U | 0 | |||||||||||
| 127777371 | 12777737 | 18 | C | PATANOL | OLOPATADINE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 127777371 | 12777737 | 19 | C | RELPAX | ELETRIPTAN HYDROBROMIDE | 1 | U | 0 | |||||||||||
| 127777371 | 12777737 | 20 | C | IMPLANON | ETONOGESTREL | 1 | U | 0 | |||||||||||
| 127777371 | 12777737 | 21 | C | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 127777371 | 12777737 | 22 | C | METHYLPHENIDATE. | METHYLPHENIDATE | 1 | U | 0 | |||||||||||
| 127777371 | 12777737 | 23 | C | HALOPERIDOL. | HALOPERIDOL | 1 | U | 0 | |||||||||||
| 127777371 | 12777737 | 24 | C | NEXPLANON | ETONOGESTREL | 1 | U | 0 | |||||||||||
| 127777371 | 12777737 | 25 | C | TOPIRAMATE. | TOPIRAMATE | 1 | U | 0 | |||||||||||
| 127777371 | 12777737 | 26 | C | TRINESSA | ETHINYL ESTRADIOLNORGESTIMATE | 1 | U | 0 | |||||||||||
| 127777371 | 12777737 | 27 | C | Valacyclovir hcl | VALACYCLOVIR HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 127777371 | 12777737 | 28 | C | SERTRALINE HCL | SERTRALINE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 127777371 | 12777737 | 29 | C | QUETIAPINE FUMARATE. | QUETIAPINE FUMARATE | 1 | U | 0 | |||||||||||
| 127777371 | 12777737 | 30 | C | Lactaid | LACTASE | 1 | U | 0 | |||||||||||
| 127777371 | 12777737 | 31 | C | VITAMIN B12 | CYANOCOBALAMIN | 1 | U | 0 | |||||||||||
| 127777371 | 12777737 | 32 | C | ADVIL | IBUPROFEN | 1 | U | 0 | |||||||||||
| 127777371 | 12777737 | 33 | C | EPIPEN | EPINEPHRINE | 1 | U | 0 | |||||||||||
| 127777371 | 12777737 | 34 | C | Prenatal vitamins | VITAMINS | 1 | U | 0 | |||||||||||
| 127777371 | 12777737 | 35 | C | VALTREX | VALACYCLOVIR HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 127777371 | 12777737 | 36 | C | IBUPROFEN. | IBUPROFEN | 1 | U | 0 | |||||||||||
| 127777371 | 12777737 | 37 | C | TYLENOL EXTRA STRENGTH | ACETAMINOPHEN | 1 | U | 0 | |||||||||||
| 127777371 | 12777737 | 38 | C | Melatonin | MELATONIN | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127777371 | 12777737 | 1 | Narcolepsy |
| 127777371 | 12777737 | 2 | Cataplexy |
| 127777371 | 12777737 | 6 | Hypersensitivity |
| 127777371 | 12777737 | 7 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127777371 | 12777737 | Abdominal discomfort | |
| 127777371 | 12777737 | Bronchitis | |
| 127777371 | 12777737 | Drug ineffective | |
| 127777371 | 12777737 | Hypersensitivity | |
| 127777371 | 12777737 | 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 |
|---|---|---|---|---|---|---|
| 127777371 | 12777737 | 1 | 201402 | 201403 | 0 | |
| 127777371 | 12777737 | 2 | 201403 | 2014 | 0 | |
| 127777371 | 12777737 | 3 | 201505 | 201505 | 0 | |
| 127777371 | 12777737 | 4 | 201505 | 201601 | 0 | |
| 127777371 | 12777737 | 5 | 201601 | 0 | ||
| 127777371 | 12777737 | 6 | 20160121 | 20160128 | 0 | |
| 127777371 | 12777737 | 7 | 201601 | 0 |