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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125215132 | 12521513 | 2 | F | 20160719 | 20160701 | 20160727 | EXP | US-JAZZ-2016-US-011841 | JAZZ | 0.00 | F | Y | 0.00000 | 20160727 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125215132 | 12521513 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | 21196 | 4.5 | G | ORAL SOLUTION | |||||||
| 125215132 | 12521513 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | 21196 | ORAL SOLUTION | |||||||||||
| 125215132 | 12521513 | 3 | C | ZOLOFT | SERTRALINE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125215132 | 12521513 | 4 | C | CARTIA XT | DILTIAZEM HYDROCHLORIDE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 125215132 | 12521513 | 5 | C | IMDUR | ISOSORBIDE MONONITRATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125215132 | 12521513 | 6 | C | ASPIRIN. | ASPIRIN | 1 | UNK | U | 0 | CHEWABLE TABLET | |||||||||
| 125215132 | 12521513 | 7 | C | LIPITOR | ATORVASTATIN CALCIUM | 1 | UNK | U | 0 | TABLET | |||||||||
| 125215132 | 12521513 | 8 | C | LISINOPRIL. | LISINOPRIL | 1 | UNK | U | 0 | TABLET | |||||||||
| 125215132 | 12521513 | 9 | C | NUVIGIL | ARMODAFINIL | 1 | UNK | U | 0 | TABLET | |||||||||
| 125215132 | 12521513 | 10 | C | FIORICET | ACETAMINOPHENBUTALBITALCAFFEINE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 125215132 | 12521513 | 11 | C | PANTOPRAZOLE SODIUM DR | PANTOPRAZOLE SODIUM | 1 | UNK | U | 0 | TABLET | |||||||||
| 125215132 | 12521513 | 12 | C | WELLBUTRIN XL | BUPROPION HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125215132 | 12521513 | 13 | C | Acetaminophen w/oxycodone | ACETAMINOPHENOXYCODONE HYDROCHLORIDE | 1 | UNK | U | 0 | ||||||||||
| 125215132 | 12521513 | 14 | C | ALPRAZOLAM ER | ALPRAZOLAM | 1 | UNK | U | 0 | TABLET | |||||||||
| 125215132 | 12521513 | 15 | C | Amphetamine salts | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125215132 | 12521513 | 16 | C | TRAZODONE | TRAZODONE HYDROCHLORIDE | 1 | UNK | U | 0 | ||||||||||
| 125215132 | 12521513 | 17 | C | ABILIFY | ARIPIPRAZOLE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125215132 | 12521513 | 18 | C | CYMBALTA | DULOXETINE HYDROCHLORIDE | 1 | 30 MG | U | 0 | CAPSULE | |||||||||
| 125215132 | 12521513 | 19 | C | CYMBALTA | DULOXETINE HYDROCHLORIDE | 1 | 60 MG | U | 0 | CAPSULE | |||||||||
| 125215132 | 12521513 | 20 | C | Zolpidem Tartrate er | ZOLPIDEM TARTRATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125215132 | 12521513 | 21 | C | LYRICA | PREGABALIN | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 125215132 | 12521513 | 22 | C | PROMETHAZINE | PROMETHAZINEPROMETHAZINE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125215132 | 12521513 | 23 | C | HYDROCHLOROTHIAZIDE. | HYDROCHLOROTHIAZIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125215132 | 12521513 | 24 | C | AMLODIPINE BESYLATE. | AMLODIPINE BESYLATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125215132 | 12521513 | 25 | C | CARVEDILOL. | CARVEDILOL | 1 | UNK | U | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125215132 | 12521513 | 1 | Narcolepsy |
| 125215132 | 12521513 | 2 | Cataplexy |
| 125215132 | 12521513 | 3 | Product used for unknown indication |
| 125215132 | 12521513 | 4 | Product used for unknown indication |
| 125215132 | 12521513 | 5 | Product used for unknown indication |
| 125215132 | 12521513 | 6 | Product used for unknown indication |
| 125215132 | 12521513 | 7 | Product used for unknown indication |
| 125215132 | 12521513 | 8 | Product used for unknown indication |
| 125215132 | 12521513 | 9 | Product used for unknown indication |
| 125215132 | 12521513 | 10 | Product used for unknown indication |
| 125215132 | 12521513 | 11 | Product used for unknown indication |
| 125215132 | 12521513 | 12 | Product used for unknown indication |
| 125215132 | 12521513 | 13 | Product used for unknown indication |
| 125215132 | 12521513 | 14 | Product used for unknown indication |
| 125215132 | 12521513 | 15 | Product used for unknown indication |
| 125215132 | 12521513 | 16 | Product used for unknown indication |
| 125215132 | 12521513 | 17 | Product used for unknown indication |
| 125215132 | 12521513 | 18 | Product used for unknown indication |
| 125215132 | 12521513 | 20 | Product used for unknown indication |
| 125215132 | 12521513 | 21 | Product used for unknown indication |
| 125215132 | 12521513 | 22 | Product used for unknown indication |
| 125215132 | 12521513 | 23 | Product used for unknown indication |
| 125215132 | 12521513 | 24 | Product used for unknown indication |
| 125215132 | 12521513 | 25 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125215132 | 12521513 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125215132 | 12521513 | Memory impairment | |
| 125215132 | 12521513 | Musculoskeletal stiffness | |
| 125215132 | 12521513 | Nausea | |
| 125215132 | 12521513 | Oesophageal spasm | |
| 125215132 | 12521513 | Oesophageal ulcer | |
| 125215132 | 12521513 | Pallor | |
| 125215132 | 12521513 | Tremor | |
| 125215132 | 12521513 | 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 |
|---|---|---|---|---|---|---|
| 125215132 | 12521513 | 1 | 201412 | 0 | ||
| 125215132 | 12521513 | 3 | 201604 | 0 | ||
| 125215132 | 12521513 | 4 | 201603 | 0 | ||
| 125215132 | 12521513 | 5 | 20151218 | 0 | ||
| 125215132 | 12521513 | 6 | 20150304 | 0 | ||
| 125215132 | 12521513 | 7 | 20150304 | 0 | ||
| 125215132 | 12521513 | 8 | 20150304 | 0 | ||
| 125215132 | 12521513 | 9 | 20150302 | 0 | ||
| 125215132 | 12521513 | 10 | 20141203 | 0 | ||
| 125215132 | 12521513 | 11 | 20141202 | 0 | ||
| 125215132 | 12521513 | 12 | 20141202 | 0 | ||
| 125215132 | 12521513 | 13 | 20140901 | 0 | ||
| 125215132 | 12521513 | 14 | 20140101 | 0 | ||
| 125215132 | 12521513 | 15 | 20140101 | 0 | ||
| 125215132 | 12521513 | 16 | 20140101 | 0 | ||
| 125215132 | 12521513 | 17 | 20130101 | 0 | ||
| 125215132 | 12521513 | 18 | 20130101 | 20141202 | 0 | |
| 125215132 | 12521513 | 19 | 20130101 | 20141202 | 0 | |
| 125215132 | 12521513 | 20 | 20130101 | 0 | ||
| 125215132 | 12521513 | 21 | 20120101 | 0 | ||
| 125215132 | 12521513 | 22 | 20120101 | 0 | ||
| 125215132 | 12521513 | 23 | 20110101 | 0 | ||
| 125215132 | 12521513 | 24 | 20070101 | 0 | ||
| 125215132 | 12521513 | 25 | 20070101 | 0 |