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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126885093 | 12688509 | 3 | F | 20160915 | 20160825 | 20160923 | EXP | US-JAZZ-2016-US-015729 | JAZZ | 0.00 | F | Y | 0.00000 | 20160923 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126885093 | 12688509 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | U | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 126885093 | 12688509 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | U | 21196 | 3 | G | ORAL SOLUTION | ||||||
| 126885093 | 12688509 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.5 G, BID | U | 21196 | 2.5 | G | ORAL SOLUTION | ||||||
| 126885093 | 12688509 | 4 | SS | RITALIN | METHYLPHENIDATE HYDROCHLORIDE | 1 | UNK | N | 0 | TABLET | |||||||||
| 126885093 | 12688509 | 5 | C | RITALIN LA | METHYLPHENIDATE HYDROCHLORIDE | 1 | UNK | N | 0 | CAPSULE | |||||||||
| 126885093 | 12688509 | 6 | C | PROLENSA | BROMFENAC SODIUM | 1 | UNK | U | 0 | EYE DROPS | |||||||||
| 126885093 | 12688509 | 7 | C | BENICAR | OLMESARTAN MEDOXOMIL | 1 | UNK | U | 0 | TABLET | |||||||||
| 126885093 | 12688509 | 8 | C | BESIVANCE | BESIFLOXACIN | 1 | UNK | U | 0 | SUSPENSION | |||||||||
| 126885093 | 12688509 | 9 | C | DUREZOL | DIFLUPREDNATE | 1 | UNK | U | 0 | EYE DROPS | |||||||||
| 126885093 | 12688509 | 10 | C | ALLOPURINOL. | ALLOPURINOL | 1 | UNK | U | 0 | TABLET | |||||||||
| 126885093 | 12688509 | 11 | C | AMLODIPINE BESYLATE. | AMLODIPINE BESYLATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126885093 | 12688509 | 12 | C | CORTISONE | CORTISONEHYDROCORTISONE | 1 | UNK | U | 0 | ||||||||||
| 126885093 | 12688509 | 13 | C | Magnesium gluconate | MAGNESIUM GLUCONATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126885093 | 12688509 | 14 | C | PLAQUENIL | HYDROXYCHLOROQUINE SULFATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126885093 | 12688509 | 15 | C | POTASSIUM CHLORIDE. | POTASSIUM CHLORIDE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 126885093 | 12688509 | 16 | C | ADVIL | IBUPROFEN | 1 | UNK | U | 0 | ||||||||||
| 126885093 | 12688509 | 17 | C | LUNESTA | ESZOPICLONE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126885093 | 12688509 | 18 | C | MAXZIDE | HYDROCHLOROTHIAZIDETRIAMTERENE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126885093 | 12688509 | 19 | C | NEXIUM | ESOMEPRAZOLE MAGNESIUM | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 126885093 | 12688509 | 20 | C | VITAMIN D | CHOLECALCIFEROL | 1 | UNK | U | 0 | TABLET | |||||||||
| 126885093 | 12688509 | 21 | C | ALLEGRA ALLERGY | FEXOFENADINE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126885093 | 12688509 | 22 | C | CLOTRIMAZOLE. | CLOTRIMAZOLE | 1 | U | 0 | |||||||||||
| 126885093 | 12688509 | 23 | C | COLCHICINE. | COLCHICINE | 1 | U | 0 | TABLET | ||||||||||
| 126885093 | 12688509 | 24 | C | Metformin hcl | METFORMIN HYDROCHLORIDE | 1 | U | 0 | TABLET | ||||||||||
| 126885093 | 12688509 | 25 | C | PROAIR HFA | ALBUTEROL SULFATE | 1 | U | 0 | INHALER | ||||||||||
| 126885093 | 12688509 | 26 | C | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDETRIAMTERENE | 1 | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126885093 | 12688509 | 1 | Narcolepsy |
| 126885093 | 12688509 | 2 | Cataplexy |
| 126885093 | 12688509 | 4 | Product used for unknown indication |
| 126885093 | 12688509 | 5 | Product used for unknown indication |
| 126885093 | 12688509 | 6 | Product used for unknown indication |
| 126885093 | 12688509 | 7 | Product used for unknown indication |
| 126885093 | 12688509 | 8 | Product used for unknown indication |
| 126885093 | 12688509 | 9 | Product used for unknown indication |
| 126885093 | 12688509 | 10 | Product used for unknown indication |
| 126885093 | 12688509 | 11 | Product used for unknown indication |
| 126885093 | 12688509 | 12 | Product used for unknown indication |
| 126885093 | 12688509 | 13 | Product used for unknown indication |
| 126885093 | 12688509 | 14 | Product used for unknown indication |
| 126885093 | 12688509 | 15 | Product used for unknown indication |
| 126885093 | 12688509 | 16 | Product used for unknown indication |
| 126885093 | 12688509 | 17 | Product used for unknown indication |
| 126885093 | 12688509 | 18 | Product used for unknown indication |
| 126885093 | 12688509 | 19 | Product used for unknown indication |
| 126885093 | 12688509 | 20 | Product used for unknown indication |
| 126885093 | 12688509 | 21 | Product used for unknown indication |
| 126885093 | 12688509 | 22 | Product used for unknown indication |
| 126885093 | 12688509 | 23 | Product used for unknown indication |
| 126885093 | 12688509 | 24 | Product used for unknown indication |
| 126885093 | 12688509 | 25 | Product used for unknown indication |
| 126885093 | 12688509 | 26 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126885093 | 12688509 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126885093 | 12688509 | Candida infection | |
| 126885093 | 12688509 | Cataract | |
| 126885093 | 12688509 | Cough | |
| 126885093 | 12688509 | Gout | |
| 126885093 | 12688509 | Hypersomnia | |
| 126885093 | 12688509 | Hypertension | |
| 126885093 | 12688509 | Sneezing |
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 |
|---|---|---|---|---|---|---|
| 126885093 | 12688509 | 1 | 200501 | 200502 | 0 | |
| 126885093 | 12688509 | 2 | 200502 | 2008 | 0 | |
| 126885093 | 12688509 | 3 | 201505 | 0 | ||
| 126885093 | 12688509 | 4 | 20150623 | 201606 | 0 | |
| 126885093 | 12688509 | 5 | 20150423 | 20160630 | 0 | |
| 126885093 | 12688509 | 6 | 20160818 | 0 | ||
| 126885093 | 12688509 | 7 | 201607 | 0 | ||
| 126885093 | 12688509 | 8 | 201607 | 0 | ||
| 126885093 | 12688509 | 9 | 201607 | 0 | ||
| 126885093 | 12688509 | 10 | 201606 | 0 | ||
| 126885093 | 12688509 | 11 | 201606 | 0 | ||
| 126885093 | 12688509 | 12 | 20150910 | 201512 | 0 | |
| 126885093 | 12688509 | 13 | 20150910 | 0 | ||
| 126885093 | 12688509 | 14 | 20150910 | 0 | ||
| 126885093 | 12688509 | 15 | 20150910 | 0 | ||
| 126885093 | 12688509 | 16 | 20160423 | 0 | ||
| 126885093 | 12688509 | 17 | 20150423 | 201512 | 0 | |
| 126885093 | 12688509 | 18 | 20150423 | 0 | ||
| 126885093 | 12688509 | 19 | 20150423 | 0 | ||
| 126885093 | 12688509 | 20 | 20150423 | 0 | ||
| 126885093 | 12688509 | 21 | 200601 | 0 | ||
| 126885093 | 12688509 | 26 | 201608 | 0 |