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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126146701 | 12614670 | 1 | I | 201602 | 20160213 | 20160802 | 20160802 | PER | US-JAZZ-2016-US-002845 | JAZZ | 39.01 | YR | F | Y | 63.49000 | KG | 20160802 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126146701 | 12614670 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | Y | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 126146701 | 12614670 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 1.5 G, BID | Y | 21196 | 1.5 | G | ORAL SOLUTION | ||||||
| 126146701 | 12614670 | 3 | SS | KLONOPIN | CLONAZEPAM | 1 | U | 0 | |||||||||||
| 126146701 | 12614670 | 4 | C | AZITHROMYCIN ANHYDROUS. | AZITHROMYCIN ANHYDROUS | 1 | UNK | U | 0 | TABLET | |||||||||
| 126146701 | 12614670 | 5 | C | IBUPROFEN. | IBUPROFEN | 1 | UNK | U | 0 | ||||||||||
| 126146701 | 12614670 | 6 | C | ACETAMINOPHEN. | ACETAMINOPHEN | 1 | UNK | U | 0 | ||||||||||
| 126146701 | 12614670 | 7 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 126146701 | 12614670 | 8 | C | Flintstones | 2 | UNK | U | 0 | TABLET | ||||||||||
| 126146701 | 12614670 | 9 | C | LAMICTAL | LAMOTRIGINE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126146701 | 12614670 | 10 | C | Sinus rinse | SODIUM BICARBONATESODIUM CHLORIDE | 1 | UNK | U | 0 | ||||||||||
| 126146701 | 12614670 | 11 | C | VENTOLIN HFA | ALBUTEROL SULFATE | 1 | UNK | U | 0 | INHALER | |||||||||
| 126146701 | 12614670 | 12 | C | BENADRYL ALLERGY | DIPHENHYDRAMINE HYDROCHLORIDE | 1 | UNK | U | 0 | ||||||||||
| 126146701 | 12614670 | 13 | C | CYANOCOBALAMIN. | CYANOCOBALAMIN | 1 | UNK | U | 0 | ||||||||||
| 126146701 | 12614670 | 14 | C | LANSOPRAZOLE. | LANSOPRAZOLE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 126146701 | 12614670 | 15 | C | Melatonin | MELATONIN | 1 | UNK | U | 0 | TABLET | |||||||||
| 126146701 | 12614670 | 16 | C | VITAMIN D3 | CHOLECALCIFEROL | 1 | UNK | U | 0 | ||||||||||
| 126146701 | 12614670 | 17 | C | BUSPAR | BUSPIRONE HYDROCHLORIDE | 1 | UNK | U | 0 | ||||||||||
| 126146701 | 12614670 | 18 | C | Proton pump inhibitors | UNSPECIFIED INGREDIENT | 1 | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126146701 | 12614670 | 1 | Narcolepsy |
| 126146701 | 12614670 | 2 | Cataplexy |
| 126146701 | 12614670 | 3 | Anxiety |
| 126146701 | 12614670 | 4 | Product used for unknown indication |
| 126146701 | 12614670 | 5 | Product used for unknown indication |
| 126146701 | 12614670 | 6 | Product used for unknown indication |
| 126146701 | 12614670 | 7 | Product used for unknown indication |
| 126146701 | 12614670 | 8 | Product used for unknown indication |
| 126146701 | 12614670 | 9 | Product used for unknown indication |
| 126146701 | 12614670 | 10 | Product used for unknown indication |
| 126146701 | 12614670 | 11 | Product used for unknown indication |
| 126146701 | 12614670 | 12 | Product used for unknown indication |
| 126146701 | 12614670 | 13 | Product used for unknown indication |
| 126146701 | 12614670 | 14 | Product used for unknown indication |
| 126146701 | 12614670 | 15 | Product used for unknown indication |
| 126146701 | 12614670 | 16 | Product used for unknown indication |
| 126146701 | 12614670 | 17 | Anxiety |
| 126146701 | 12614670 | 18 | Gastrooesophageal reflux disease |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126146701 | 12614670 | Anxiety | |
| 126146701 | 12614670 | Bronchitis | |
| 126146701 | 12614670 | Choking sensation | |
| 126146701 | 12614670 | Confusional state | |
| 126146701 | 12614670 | Dysphagia | |
| 126146701 | 12614670 | Dyspnoea | |
| 126146701 | 12614670 | Feeling abnormal | |
| 126146701 | 12614670 | Hyperhidrosis | |
| 126146701 | 12614670 | Memory impairment | |
| 126146701 | 12614670 | Movement disorder | |
| 126146701 | 12614670 | Temporomandibular joint syndrome | |
| 126146701 | 12614670 | Throat tightness | |
| 126146701 | 12614670 | Unevaluable event |
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 |
|---|---|---|---|---|---|---|
| 126146701 | 12614670 | 1 | 20160214 | 201602 | 0 | |
| 126146701 | 12614670 | 2 | 201602 | 0 | ||
| 126146701 | 12614670 | 4 | 20160223 | 0 | ||
| 126146701 | 12614670 | 5 | 20160209 | 0 | ||
| 126146701 | 12614670 | 6 | 20160114 | 0 | ||
| 126146701 | 12614670 | 7 | 20160209 | 20160216 | 0 | |
| 126146701 | 12614670 | 8 | 20160114 | 0 | ||
| 126146701 | 12614670 | 9 | 20160114 | 0 | ||
| 126146701 | 12614670 | 10 | 20160114 | 0 | ||
| 126146701 | 12614670 | 11 | 20160114 | 0 |