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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126511491 | 12651149 | 1 | I | 2016 | 20160316 | 20160815 | 20160815 | PER | US-JAZZ-2016-US-005219 | JAZZ | 0.00 | F | Y | 0.00000 | 20160815 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126511491 | 12651149 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | U | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 126511491 | 12651149 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | U | 21196 | ORAL SOLUTION | ||||||||
| 126511491 | 12651149 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, AS FIRST DOSE | U | 21196 | 4.5 | G | ORAL SOLUTION | ||||||
| 126511491 | 12651149 | 4 | SS | CLONAZEPAM. | CLONAZEPAM | 1 | UNK | 0 | |||||||||||
| 126511491 | 12651149 | 5 | SS | PHENERGAN | PROMETHAZINE HYDROCHLORIDE | 1 | UNK | 0 | |||||||||||
| 126511491 | 12651149 | 6 | C | MEDROL | METHYLPREDNISOLONE | 1 | U | 0 | |||||||||||
| 126511491 | 12651149 | 7 | C | BACTRIM DS | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | U | 0 | |||||||||||
| 126511491 | 12651149 | 8 | C | CYMBALTA | DULOXETINE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 126511491 | 12651149 | 9 | C | ATENOLOL. | ATENOLOL | 1 | U | 0 | |||||||||||
| 126511491 | 12651149 | 10 | C | BELVIQ | LORCASERIN HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 126511491 | 12651149 | 11 | C | BUTRANS | BUPRENORPHINE | 1 | U | 0 | |||||||||||
| 126511491 | 12651149 | 12 | C | CRESTOR | ROSUVASTATIN CALCIUM | 1 | U | 0 | |||||||||||
| 126511491 | 12651149 | 13 | C | Dexilant dr | 2 | U | 0 | ||||||||||||
| 126511491 | 12651149 | 14 | C | FLEXERIL | CYCLOBENZAPRINE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 126511491 | 12651149 | 15 | C | LEXAPRO | ESCITALOPRAM OXALATE | 1 | U | 0 | |||||||||||
| 126511491 | 12651149 | 16 | C | LYRICA | PREGABALIN | 1 | U | 0 | |||||||||||
| 126511491 | 12651149 | 17 | C | METFORMIN HYDROCHLORIDE. | METFORMIN HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 126511491 | 12651149 | 18 | C | METHOTREXATE. | METHOTREXATE | 1 | U | 0 | |||||||||||
| 126511491 | 12651149 | 19 | C | PLAQUENIL | HYDROXYCHLOROQUINE SULFATE | 1 | U | 0 | |||||||||||
| 126511491 | 12651149 | 20 | C | PLAVIX | CLOPIDOGREL BISULFATE | 1 | U | 0 | |||||||||||
| 126511491 | 12651149 | 21 | C | SYNTHROID | LEVOTHYROXINE SODIUM | 1 | U | 0 | |||||||||||
| 126511491 | 12651149 | 22 | C | METHYLPHENIDATE. | METHYLPHENIDATE | 1 | U | 0 | |||||||||||
| 126511491 | 12651149 | 23 | C | FOLIC ACID. | FOLIC ACID | 1 | U | 0 | |||||||||||
| 126511491 | 12651149 | 24 | C | MOBIC | MELOXICAM | 1 | U | 0 | |||||||||||
| 126511491 | 12651149 | 25 | C | LASIX | FUROSEMIDE | 1 | U | 0 | |||||||||||
| 126511491 | 12651149 | 26 | C | Potassium cl er | POTASSIUM CHLORIDE | 1 | U | 0 | |||||||||||
| 126511491 | 12651149 | 27 | C | SPIRONOLACTONE. | SPIRONOLACTONE | 1 | U | 0 | |||||||||||
| 126511491 | 12651149 | 28 | C | ZOFRAN | ONDANSETRON HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 126511491 | 12651149 | 29 | C | FERROUS SULFATE. | FERROUS SULFATE | 1 | U | 0 | |||||||||||
| 126511491 | 12651149 | 30 | C | Hydrocodone / Ibuprofen | HYDROCODONE BITARTRATEIBUPROFEN | 1 | U | 0 | |||||||||||
| 126511491 | 12651149 | 31 | C | NEUPRO | ROTIGOTINE | 1 | U | 0 | |||||||||||
| 126511491 | 12651149 | 32 | C | SALAGEN | PILOCARPINE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 126511491 | 12651149 | 33 | C | TUMS SMOOTHIES | CALCIUM CARBONATE | 1 | U | 0 | |||||||||||
| 126511491 | 12651149 | 34 | C | ALLEGRA ALLERGY | FEXOFENADINE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 126511491 | 12651149 | 35 | C | Dhea | PRASTERONE | 1 | U | 0 | |||||||||||
| 126511491 | 12651149 | 36 | C | MAGNESIUM OXIDE. | MAGNESIUM OXIDE | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126511491 | 12651149 | 1 | Narcolepsy |
| 126511491 | 12651149 | 4 | Product used for unknown indication |
| 126511491 | 12651149 | 5 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126511491 | 12651149 | Acne | |
| 126511491 | 12651149 | Anxiety | |
| 126511491 | 12651149 | Blood pressure increased | |
| 126511491 | 12651149 | Cystitis | |
| 126511491 | 12651149 | Labelled drug-drug interaction medication error | |
| 126511491 | 12651149 | Nausea |
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 |
|---|---|---|---|---|---|---|
| 126511491 | 12651149 | 1 | 201602 | 201602 | 0 |