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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125580531 | 12558053 | 1 | I | 20160111 | 20160714 | 20160714 | PER | US-JAZZ-2016-US-000459 | JAZZ | 0.00 | F | Y | 63.49000 | KG | 20160714 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125580531 | 12558053 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 1.5 G, BID | 21196 | 1.5 | G | ORAL SOLUTION | |||||||
| 125580531 | 12558053 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | 21196 | 3 | G | ORAL SOLUTION | |||||||
| 125580531 | 12558053 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.75 G, BID | 21196 | 3.75 | G | ORAL SOLUTION | |||||||
| 125580531 | 12558053 | 4 | SS | RITALIN | METHYLPHENIDATE HYDROCHLORIDE | 1 | 10 MG, PRN | 0 | 10 | MG | TABLET | ||||||||
| 125580531 | 12558053 | 5 | SS | PROVIGIL | MODAFINIL | 1 | 400 MG, UNK | 0 | 400 | MG | TABLET | ||||||||
| 125580531 | 12558053 | 6 | SS | RITALIN LA | METHYLPHENIDATE HYDROCHLORIDE | 1 | 30 MG, UNK | 0 | 30 | MG | CAPSULE | ||||||||
| 125580531 | 12558053 | 7 | C | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125580531 | 12558053 | 8 | C | VERAPAMIL | VERAPAMIL HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125580531 | 12558053 | 9 | C | VITAMIN D | CHOLECALCIFEROL | 1 | UNK | U | 0 | TABLET | |||||||||
| 125580531 | 12558053 | 10 | C | VITAMIN B COMPLEX | CYANOCOBALAMINDEXPANTHENOLNIACINAMIDEPYRIDOXINE HYDROCHLORIDERIBOFLAVIN 5'-PHOSPHATE SODIUMTHIAMINE HYDROCHLORIDEVITAMIN B COMPLEX | 1 | UNK | U | 0 | TABLET | |||||||||
| 125580531 | 12558053 | 11 | C | Biotin | BIOTIN | 1 | UNK | U | 0 | TABLET | |||||||||
| 125580531 | 12558053 | 12 | C | Omega 3 | OMEGA-3 FATTY ACIDS | 1 | UNK | U | 0 | ||||||||||
| 125580531 | 12558053 | 13 | C | BENICAR | OLMESARTAN MEDOXOMIL | 1 | UNK | U | 0 | ||||||||||
| 125580531 | 12558053 | 14 | C | BONIVA | IBANDRONATE SODIUM | 1 | UNK | U | 0 | ||||||||||
| 125580531 | 12558053 | 15 | C | VITAMIN C | ASCORBIC ACID | 1 | UNK | U | 0 | ||||||||||
| 125580531 | 12558053 | 16 | C | Fish oil | FISH OIL | 1 | UNK | U | 0 | ||||||||||
| 125580531 | 12558053 | 17 | C | LOSARTAN POTASSIUM. | LOSARTAN POTASSIUM | 1 | UNK | U | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125580531 | 12558053 | 1 | Narcolepsy |
| 125580531 | 12558053 | 2 | Cataplexy |
| 125580531 | 12558053 | 4 | Narcolepsy |
| 125580531 | 12558053 | 5 | Product used for unknown indication |
| 125580531 | 12558053 | 6 | Narcolepsy |
| 125580531 | 12558053 | 7 | Cataplexy |
| 125580531 | 12558053 | 8 | Hypertension |
| 125580531 | 12558053 | 9 | Vitamin supplementation |
| 125580531 | 12558053 | 10 | Vitamin supplementation |
| 125580531 | 12558053 | 11 | Vitamin supplementation |
| 125580531 | 12558053 | 12 | Supplementation therapy |
| 125580531 | 12558053 | 13 | Product used for unknown indication |
| 125580531 | 12558053 | 14 | Product used for unknown indication |
| 125580531 | 12558053 | 15 | Product used for unknown indication |
| 125580531 | 12558053 | 16 | Product used for unknown indication |
| 125580531 | 12558053 | 17 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125580531 | 12558053 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125580531 | 12558053 | Pre-existing condition improved | |
| 125580531 | 12558053 | Therapeutic response unexpected | |
| 125580531 | 12558053 | Weight decreased |
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 |
|---|---|---|---|---|---|---|
| 125580531 | 12558053 | 1 | 200609 | 200611 | 0 | |
| 125580531 | 12558053 | 2 | 200611 | 200807 | 0 | |
| 125580531 | 12558053 | 3 | 200807 | 0 | ||
| 125580531 | 12558053 | 4 | 20160105 | 20160111 | 0 | |
| 125580531 | 12558053 | 5 | 20130722 | 20160111 | 0 | |
| 125580531 | 12558053 | 6 | 20160105 | 0 | ||
| 125580531 | 12558053 | 7 | 20160105 | 0 | ||
| 125580531 | 12558053 | 8 | 20160105 | 0 | ||
| 125580531 | 12558053 | 9 | 20160105 | 0 | ||
| 125580531 | 12558053 | 10 | 20160105 | 0 | ||
| 125580531 | 12558053 | 11 | 20160105 | 0 | ||
| 125580531 | 12558053 | 15 | 20160108 | 0 | ||
| 125580531 | 12558053 | 16 | 20160105 | 20160111 | 0 | |
| 125580531 | 12558053 | 17 | 20160105 | 0 |