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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126049232 | 12604923 | 2 | F | 201511 | 20160809 | 20160728 | 20160816 | EXP | US-JAZZ-2016-US-013766 | JAZZ | 37.76 | YR | F | Y | 0.00000 | 20160816 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126049232 | 12604923 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | 21196 | 2.25 | G | ORAL SOLUTION | |||||||
| 126049232 | 12604923 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | 21196 | ORAL SOLUTION | |||||||||
| 126049232 | 12604923 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | 21196 | ORAL SOLUTION | |||||||||
| 126049232 | 12604923 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | 21196 | 4.5 | G | ORAL SOLUTION | |||||||
| 126049232 | 12604923 | 5 | SS | IVIG | HUMAN IMMUNOGLOBULIN G | 1 | UNK | U | 0 | ||||||||||
| 126049232 | 12604923 | 6 | SS | TAGAMET | CIMETIDINE | 1 | U | 0 | |||||||||||
| 126049232 | 12604923 | 7 | C | Diphenhydramine Hcl | DIPHENHYDRAMINE HYDROCHLORIDE | 1 | UNK | U | 0 | ||||||||||
| 126049232 | 12604923 | 8 | C | Amantadine | AMANTADINE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 126049232 | 12604923 | 9 | C | VITAMIN D | CHOLECALCIFEROL | 1 | UNK | U | 0 | TABLET | |||||||||
| 126049232 | 12604923 | 10 | C | ADDERALL | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126049232 | 12604923 | 11 | C | ALLEGRA ALLERGY | FEXOFENADINE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126049232 | 12604923 | 12 | C | ARTIFICIAL TEARS | GLYCERINHYPROMELLOSESPOLYETHYLENE GLYCOL 400 | 1 | UNK | U | 0 | DROP | |||||||||
| 126049232 | 12604923 | 13 | C | ARTIFICIAL TEARS | GLYCERINHYPROMELLOSESPOLYETHYLENE GLYCOL 400 | 1 | UNK | U | 0 | DROP | |||||||||
| 126049232 | 12604923 | 14 | C | CARAFATE | SUCRALFATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126049232 | 12604923 | 15 | C | CLARITIN | LORATADINE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126049232 | 12604923 | 16 | C | HYDROCHLOROTHIAZIDE. | HYDROCHLOROTHIAZIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126049232 | 12604923 | 17 | C | LIDOCAINE. | LIDOCAINE | 1 | UNK | U | 0 | PATCH | |||||||||
| 126049232 | 12604923 | 18 | C | Lisinopril/hctz | HYDROCHLOROTHIAZIDELISINOPRIL | 1 | UNK | U | 0 | TABLET | |||||||||
| 126049232 | 12604923 | 19 | C | NIZORAL A-D | KETOCONAZOLE | 1 | UNK | U | 0 | SHAMPOO | |||||||||
| 126049232 | 12604923 | 20 | C | NORVASC | AMLODIPINE BESYLATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126049232 | 12604923 | 21 | C | PREVACID | LANSOPRAZOLE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 126049232 | 12604923 | 22 | C | PRILOSEC | OMEPRAZOLE MAGNESIUM | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 126049232 | 12604923 | 23 | C | ZANTAC | RANITIDINE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126049232 | 12604923 | 24 | C | ATENOLOL. | ATENOLOL | 1 | UNK | U | 0 | TABLET | |||||||||
| 126049232 | 12604923 | 25 | C | CARVEDILOL. | CARVEDILOL | 1 | U | 0 | TABLET | ||||||||||
| 126049232 | 12604923 | 26 | C | FAMOTIDINE. | FAMOTIDINE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126049232 | 12604923 | 27 | C | FAMOTIDINE. | FAMOTIDINE | 1 | UNK | U | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126049232 | 12604923 | 1 | Narcolepsy |
| 126049232 | 12604923 | 2 | Cataplexy |
| 126049232 | 12604923 | 5 | Product used for unknown indication |
| 126049232 | 12604923 | 6 | Product used for unknown indication |
| 126049232 | 12604923 | 7 | Product used for unknown indication |
| 126049232 | 12604923 | 8 | Product used for unknown indication |
| 126049232 | 12604923 | 9 | Product used for unknown indication |
| 126049232 | 12604923 | 10 | Product used for unknown indication |
| 126049232 | 12604923 | 11 | Product used for unknown indication |
| 126049232 | 12604923 | 12 | Product used for unknown indication |
| 126049232 | 12604923 | 14 | Product used for unknown indication |
| 126049232 | 12604923 | 15 | Product used for unknown indication |
| 126049232 | 12604923 | 16 | Product used for unknown indication |
| 126049232 | 12604923 | 17 | Product used for unknown indication |
| 126049232 | 12604923 | 18 | Product used for unknown indication |
| 126049232 | 12604923 | 19 | Product used for unknown indication |
| 126049232 | 12604923 | 20 | Product used for unknown indication |
| 126049232 | 12604923 | 21 | Product used for unknown indication |
| 126049232 | 12604923 | 22 | Product used for unknown indication |
| 126049232 | 12604923 | 23 | Product used for unknown indication |
| 126049232 | 12604923 | 24 | Product used for unknown indication |
| 126049232 | 12604923 | 25 | Product used for unknown indication |
| 126049232 | 12604923 | 26 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126049232 | 12604923 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126049232 | 12604923 | Cognitive disorder | |
| 126049232 | 12604923 | Drug hypersensitivity | |
| 126049232 | 12604923 | Fibromyalgia | |
| 126049232 | 12604923 | Lymphadenopathy | |
| 126049232 | 12604923 | Meningitis | |
| 126049232 | 12604923 | Obsessive-compulsive disorder |
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 |
|---|---|---|---|---|---|---|
| 126049232 | 12604923 | 1 | 201003 | 201003 | 0 | |
| 126049232 | 12604923 | 2 | 201003 | 2010 | 0 | |
| 126049232 | 12604923 | 3 | 201107 | 201310 | 0 | |
| 126049232 | 12604923 | 4 | 201310 | 0 | ||
| 126049232 | 12604923 | 5 | 20160605 | 20160607 | 0 | |
| 126049232 | 12604923 | 7 | 20160605 | 20160607 | 0 | |
| 126049232 | 12604923 | 8 | 20160505 | 201606 | 0 | |
| 126049232 | 12604923 | 9 | 20160505 | 201607 | 0 | |
| 126049232 | 12604923 | 10 | 20150102 | 0 | ||
| 126049232 | 12604923 | 11 | 20150102 | 0 | ||
| 126049232 | 12604923 | 13 | 20150102 | 20150102 | 0 | |
| 126049232 | 12604923 | 14 | 20150102 | 0 | ||
| 126049232 | 12604923 | 15 | 20150102 | 20150102 | 0 | |
| 126049232 | 12604923 | 16 | 20150102 | 0 | ||
| 126049232 | 12604923 | 17 | 20150102 | 0 | ||
| 126049232 | 12604923 | 18 | 20150102 | 20150102 | 0 | |
| 126049232 | 12604923 | 19 | 20150102 | 0 | ||
| 126049232 | 12604923 | 20 | 20150102 | 201607 | 0 | |
| 126049232 | 12604923 | 21 | 20150102 | 20150102 | 0 | |
| 126049232 | 12604923 | 22 | 20150102 | 20150102 | 0 | |
| 126049232 | 12604923 | 23 | 20150102 | 20150102 | 0 | |
| 126049232 | 12604923 | 24 | 20140912 | 201607 | 0 | |
| 126049232 | 12604923 | 26 | 20160720 | 0 |