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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114725773 | 11472577 | 3 | F | 20140602 | 20160802 | 20150908 | 20160810 | EXP | US-JAZZ-2015-US-012913 | JAZZ | 67.90 | YR | F | Y | 0.00000 | 20160810 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114725773 | 11472577 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | 21196 | 2.25 | G | ORAL SOLUTION | |||||||
| 114725773 | 11472577 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | 21196 | 4.5 | G | ORAL SOLUTION | |||||||
| 114725773 | 11472577 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, FIRST DOSE | 21196 | 3 | G | ORAL SOLUTION | |||||||
| 114725773 | 11472577 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.5 G, SECOND DOSE | 21196 | 2.5 | G | ORAL SOLUTION | |||||||
| 114725773 | 11472577 | 5 | C | LEVOTHYROXINE. | LEVOTHYROXINE | 1 | UNK | 0 | TABLET | ||||||||||
| 114725773 | 11472577 | 6 | C | CYANOCOBALAMIN. | CYANOCOBALAMIN | 1 | UNK | 0 | |||||||||||
| 114725773 | 11472577 | 7 | C | ISOSORBIDE. | ISOSORBIDE | 1 | UNK | 0 | TABLET | ||||||||||
| 114725773 | 11472577 | 8 | C | NITROGLYCERIN. | NITROGLYCERIN | 1 | UNK | 0 | TABLET | ||||||||||
| 114725773 | 11472577 | 9 | C | ALBUTEROL SULFATE. | ALBUTEROL SULFATE | 1 | UNK | 0 | SOLUTION | ||||||||||
| 114725773 | 11472577 | 10 | C | SOLU-MEDROL | METHYLPREDNISOLONE SODIUM SUCCINATE | 1 | UNK | 0 | |||||||||||
| 114725773 | 11472577 | 11 | C | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | UNK | 0 | CAPSULE | ||||||||||
| 114725773 | 11472577 | 12 | C | ADVAIR HFA | FLUTICASONE PROPIONATESALMETEROL XINAFOATE | 1 | UNK | 0 | |||||||||||
| 114725773 | 11472577 | 13 | C | ABILIFY | ARIPIPRAZOLE | 1 | UNK | 0 | TABLET | ||||||||||
| 114725773 | 11472577 | 14 | C | CYMBALTA | DULOXETINE HYDROCHLORIDE | 1 | UNK | 0 | CAPSULE | ||||||||||
| 114725773 | 11472577 | 15 | C | CYMBALTA | DULOXETINE HYDROCHLORIDE | 1 | 0 | CAPSULE | |||||||||||
| 114725773 | 11472577 | 16 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | UNK | 0 | CAPSULE | ||||||||||
| 114725773 | 11472577 | 17 | C | PROAIR HFA | ALBUTEROL SULFATE | 1 | UNK | 0 | INHALER | ||||||||||
| 114725773 | 11472577 | 18 | C | ALEVE | NAPROXEN SODIUM | 1 | UNK | 0 | |||||||||||
| 114725773 | 11472577 | 19 | C | METAMUCIL | PLANTAGO SEED | 1 | UNK | 0 | CAPSULE | ||||||||||
| 114725773 | 11472577 | 20 | C | TYLENOL | ACETAMINOPHEN | 1 | UNK | 0 | |||||||||||
| 114725773 | 11472577 | 21 | C | COPAXONE | GLATIRAMER ACETATE | 1 | UNK | 0 | INJECTION | ||||||||||
| 114725773 | 11472577 | 22 | C | MELOXICAM. | MELOXICAM | 1 | UNK | 0 | TABLET | ||||||||||
| 114725773 | 11472577 | 23 | C | PROZAC | FLUOXETINE HYDROCHLORIDE | 1 | UNK | 0 | |||||||||||
| 114725773 | 11472577 | 24 | C | PROVIGIL | MODAFINIL | 1 | UNK | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 114725773 | 11472577 | 1 | Narcolepsy |
| 114725773 | 11472577 | 2 | Somnolence |
| 114725773 | 11472577 | 5 | Hypothyroidism |
| 114725773 | 11472577 | 6 | Product used for unknown indication |
| 114725773 | 11472577 | 7 | Product used for unknown indication |
| 114725773 | 11472577 | 8 | Chest pain |
| 114725773 | 11472577 | 9 | Product used for unknown indication |
| 114725773 | 11472577 | 10 | Multiple sclerosis |
| 114725773 | 11472577 | 11 | Product used for unknown indication |
| 114725773 | 11472577 | 12 | Product used for unknown indication |
| 114725773 | 11472577 | 13 | Product used for unknown indication |
| 114725773 | 11472577 | 14 | Pain |
| 114725773 | 11472577 | 15 | Depression |
| 114725773 | 11472577 | 16 | Gastrooesophageal reflux disease |
| 114725773 | 11472577 | 17 | Product used for unknown indication |
| 114725773 | 11472577 | 18 | Product used for unknown indication |
| 114725773 | 11472577 | 19 | Product used for unknown indication |
| 114725773 | 11472577 | 20 | Product used for unknown indication |
| 114725773 | 11472577 | 21 | Product used for unknown indication |
| 114725773 | 11472577 | 22 | Product used for unknown indication |
| 114725773 | 11472577 | 23 | Depression |
| 114725773 | 11472577 | 24 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 114725773 | 11472577 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 114725773 | 11472577 | Abdominal discomfort | |
| 114725773 | 11472577 | Drug effect decreased | |
| 114725773 | 11472577 | Dysphonia | |
| 114725773 | 11472577 | Fatigue | |
| 114725773 | 11472577 | Intentional product use issue | |
| 114725773 | 11472577 | Myocardial infarction | |
| 114725773 | 11472577 | Pernicious anaemia | |
| 114725773 | 11472577 | Pneumonia |
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 |
|---|---|---|---|---|---|---|
| 114725773 | 11472577 | 1 | 201305 | 2013 | 0 | |
| 114725773 | 11472577 | 2 | 2013 | 2014 | 0 | |
| 114725773 | 11472577 | 3 | 2015 | 0 | ||
| 114725773 | 11472577 | 4 | 2015 | 0 | ||
| 114725773 | 11472577 | 6 | 20150630 | 0 | ||
| 114725773 | 11472577 | 7 | 20150420 | 0 | ||
| 114725773 | 11472577 | 8 | 20140922 | 0 | ||
| 114725773 | 11472577 | 9 | 20130502 | 0 | ||
| 114725773 | 11472577 | 10 | 20150325 | 0 | ||
| 114725773 | 11472577 | 11 | 20130122 | 0 | ||
| 114725773 | 11472577 | 12 | 20110301 | 0 | ||
| 114725773 | 11472577 | 13 | 20100301 | 0 | ||
| 114725773 | 11472577 | 14 | 20100301 | 0 | ||
| 114725773 | 11472577 | 16 | 20060301 | 0 | ||
| 114725773 | 11472577 | 17 | 20030301 | 0 | ||
| 114725773 | 11472577 | 18 | 20010101 | 0 | ||
| 114725773 | 11472577 | 19 | 20010101 | 0 | ||
| 114725773 | 11472577 | 20 | 20010101 | 0 | ||
| 114725773 | 11472577 | 21 | 20130325 | 20150830 | 0 | |
| 114725773 | 11472577 | 22 | 20121001 | 20150830 | 0 | |
| 114725773 | 11472577 | 23 | 20100301 | 20150830 | 0 | |
| 114725773 | 11472577 | 24 | 20010301 | 20150830 | 0 |