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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118734813 | 11873481 | 3 | F | 201512 | 20160721 | 20151228 | 20160728 | EXP | US-JAZZ-2015-US-021878 | JAZZ | 45.94 | YR | F | Y | 0.00000 | 20160728 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118734813 | 11873481 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | U | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 118734813 | 11873481 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | U | 21196 | ORAL SOLUTION | ||||||||
| 118734813 | 11873481 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | U | 21196 | 4.5 | G | ORAL SOLUTION | ||||||
| 118734813 | 11873481 | 4 | C | CLONAZEPAM. | CLONAZEPAM | 1 | UNK | U | 0 | TABLET | |||||||||
| 118734813 | 11873481 | 5 | C | EPIPEN | EPINEPHRINE | 1 | UNK | U | 0 | ||||||||||
| 118734813 | 11873481 | 6 | C | GABAPENTIN. | GABAPENTIN | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 118734813 | 11873481 | 7 | C | LATISSE | BIMATOPROST | 1 | UNK | U | 0 | ||||||||||
| 118734813 | 11873481 | 8 | C | VITAMIN D3 | CHOLECALCIFEROL | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 118734813 | 11873481 | 9 | C | LYRICA | PREGABALIN | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 118734813 | 11873481 | 10 | C | METOCLOPRAMIDE. | METOCLOPRAMIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 118734813 | 11873481 | 11 | C | Mycophenolate | MYCOPHENOLIC ACID | 1 | UNK | U | 0 | TABLET | |||||||||
| 118734813 | 11873481 | 12 | C | NEXIUM | ESOMEPRAZOLE MAGNESIUM | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 118734813 | 11873481 | 13 | C | NAPROXEN. | NAPROXEN | 1 | 250 MG | U | 0 | TABLET | |||||||||
| 118734813 | 11873481 | 14 | C | NAPROXEN. | NAPROXEN | 1 | 500 MG | U | 0 | TABLET | |||||||||
| 118734813 | 11873481 | 15 | C | PROCARDIA | NIFEDIPINE | 1 | UNK | U | 0 | TABLET | |||||||||
| 118734813 | 11873481 | 16 | C | PROAIR HFA | ALBUTEROL SULFATE | 1 | UNK | U | 0 | INHALER | |||||||||
| 118734813 | 11873481 | 17 | C | SYSTANE BALANCE | PROPYLENE GLYCOL | 1 | UNK | U | 0 | EYE DROPS | |||||||||
| 118734813 | 11873481 | 18 | C | VOLTAREN | DICLOFENAC SODIUM | 1 | UNK | U | 0 | GEL | |||||||||
| 118734813 | 11873481 | 19 | C | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 118734813 | 11873481 | 20 | C | LISINOPRIL. | LISINOPRIL | 1 | UNK | U | 0 | TABLET | |||||||||
| 118734813 | 11873481 | 21 | C | Prazosin | PRAZOSIN | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 118734813 | 11873481 | 22 | C | PROMETHAZINE | PROMETHAZINEPROMETHAZINE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 118734813 | 11873481 | 23 | C | SERTRALINE HCL | SERTRALINE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 118734813 | 11873481 | 24 | C | SILDENAFIL. | SILDENAFIL | 1 | UNK | U | 0 | TABLET | |||||||||
| 118734813 | 11873481 | 25 | C | METHYLPHENIDATE. | METHYLPHENIDATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 118734813 | 11873481 | 26 | C | ADDERALL | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 118734813 | 11873481 | 27 | C | AMLODIPINE BESYLATE. | AMLODIPINE BESYLATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 118734813 | 11873481 | 28 | C | BENTYL | DICYCLOMINE HYDROCHLORIDE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 118734813 | 11873481 | 29 | C | PREDNISONE. | PREDNISONE | 1 | 10 MG | U | 0 | TABLET | |||||||||
| 118734813 | 11873481 | 30 | C | PREDNISONE. | PREDNISONE | 1 | 5 MG | U | 0 | TABLET | |||||||||
| 118734813 | 11873481 | 31 | C | PRILOSEC | OMEPRAZOLE MAGNESIUM | 1 | UNK | U | 0 | CAPSULE |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 118734813 | 11873481 | 1 | Narcolepsy |
| 118734813 | 11873481 | 2 | Cataplexy |
| 118734813 | 11873481 | 4 | Product used for unknown indication |
| 118734813 | 11873481 | 5 | Product used for unknown indication |
| 118734813 | 11873481 | 6 | Product used for unknown indication |
| 118734813 | 11873481 | 7 | Product used for unknown indication |
| 118734813 | 11873481 | 8 | Product used for unknown indication |
| 118734813 | 11873481 | 9 | Product used for unknown indication |
| 118734813 | 11873481 | 10 | Product used for unknown indication |
| 118734813 | 11873481 | 11 | Product used for unknown indication |
| 118734813 | 11873481 | 12 | Product used for unknown indication |
| 118734813 | 11873481 | 13 | Product used for unknown indication |
| 118734813 | 11873481 | 15 | Product used for unknown indication |
| 118734813 | 11873481 | 16 | Product used for unknown indication |
| 118734813 | 11873481 | 17 | Product used for unknown indication |
| 118734813 | 11873481 | 18 | Product used for unknown indication |
| 118734813 | 11873481 | 19 | Product used for unknown indication |
| 118734813 | 11873481 | 20 | Product used for unknown indication |
| 118734813 | 11873481 | 21 | Product used for unknown indication |
| 118734813 | 11873481 | 22 | Product used for unknown indication |
| 118734813 | 11873481 | 23 | Product used for unknown indication |
| 118734813 | 11873481 | 24 | Product used for unknown indication |
| 118734813 | 11873481 | 25 | Product used for unknown indication |
| 118734813 | 11873481 | 26 | Product used for unknown indication |
| 118734813 | 11873481 | 27 | Product used for unknown indication |
| 118734813 | 11873481 | 28 | Product used for unknown indication |
| 118734813 | 11873481 | 29 | Product used for unknown indication |
| 118734813 | 11873481 | 31 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 118734813 | 11873481 | HO |
| 118734813 | 11873481 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 118734813 | 11873481 | Abdominal pain upper | |
| 118734813 | 11873481 | Anxiety | |
| 118734813 | 11873481 | Aspiration | |
| 118734813 | 11873481 | Depression | |
| 118734813 | 11873481 | Drug dose omission | |
| 118734813 | 11873481 | Haematemesis | |
| 118734813 | 11873481 | Headache | |
| 118734813 | 11873481 | Malaise | |
| 118734813 | 11873481 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 118734813 | 11873481 | 1 | 201407 | 201407 | 0 | |
| 118734813 | 11873481 | 2 | 201407 | 201408 | 0 | |
| 118734813 | 11873481 | 3 | 201408 | 0 | ||
| 118734813 | 11873481 | 4 | 20151208 | 0 | ||
| 118734813 | 11873481 | 5 | 20151208 | 0 | ||
| 118734813 | 11873481 | 6 | 20151208 | 0 | ||
| 118734813 | 11873481 | 7 | 20151208 | 0 | ||
| 118734813 | 11873481 | 8 | 20151208 | 0 | ||
| 118734813 | 11873481 | 9 | 20151130 | 0 | ||
| 118734813 | 11873481 | 10 | 20151130 | 0 | ||
| 118734813 | 11873481 | 11 | 20151130 | 0 | ||
| 118734813 | 11873481 | 12 | 20151130 | 0 | ||
| 118734813 | 11873481 | 13 | 20140707 | 20151204 | 0 | |
| 118734813 | 11873481 | 14 | 20151130 | 0 | ||
| 118734813 | 11873481 | 15 | 20151130 | 0 | ||
| 118734813 | 11873481 | 16 | 20151130 | 0 | ||
| 118734813 | 11873481 | 17 | 20151130 | 0 | ||
| 118734813 | 11873481 | 18 | 20151130 | 0 | ||
| 118734813 | 11873481 | 19 | 20151130 | 0 | ||
| 118734813 | 11873481 | 20 | 20150514 | 0 | ||
| 118734813 | 11873481 | 21 | 20150316 | 0 | ||
| 118734813 | 11873481 | 22 | 20150316 | 0 | ||
| 118734813 | 11873481 | 23 | 20150316 | 0 | ||
| 118734813 | 11873481 | 24 | 20141204 | 0 | ||
| 118734813 | 11873481 | 25 | 20141105 | 0 | ||
| 118734813 | 11873481 | 26 | 20140707 | 0 | ||
| 118734813 | 11873481 | 27 | 20140707 | 20150514 | 0 | |
| 118734813 | 11873481 | 28 | 20140707 | 0 | ||
| 118734813 | 11873481 | 29 | 20140707 | 0 | ||
| 118734813 | 11873481 | 30 | 20151130 | 0 | ||
| 118734813 | 11873481 | 31 | 20140707 | 20151204 | 0 |