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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125183533 | 12518353 | 3 | F | 2011 | 20160826 | 20160630 | 20160902 | EXP | US-JAZZ-JPI-P-019268 | JAZZ | 39.20 | YR | F | Y | 66.00000 | KG | 20160902 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125183533 | 12518353 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | 21196 | 2.25 | G | ORAL SOLUTION | |||||||
| 125183533 | 12518353 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | 21196 | 3 | G | ORAL SOLUTION | |||||||
| 125183533 | 12518353 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, FIRST DOSE | 21196 | 4.5 | G | ORAL SOLUTION | |||||||
| 125183533 | 12518353 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, SECOND DOSE | 21196 | 3 | G | ORAL SOLUTION | |||||||
| 125183533 | 12518353 | 5 | C | MONTELUKAST SODIUM. | MONTELUKAST SODIUM | 1 | UNK | U | 0 | TABLET | |||||||||
| 125183533 | 12518353 | 6 | C | MONTELUKAST SODIUM. | MONTELUKAST SODIUM | 1 | U | 0 | TABLET | ||||||||||
| 125183533 | 12518353 | 7 | C | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | UNK | U | 0 | INHALER | |||||||||
| 125183533 | 12518353 | 8 | C | ALBUTEROL SULFATE. | ALBUTEROL SULFATE | 1 | UNK | U | 0 | INHALER | |||||||||
| 125183533 | 12518353 | 9 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 125183533 | 12518353 | 10 | C | MELOXICAM. | MELOXICAM | 1 | UNK | 0 | TABLET | ||||||||||
| 125183533 | 12518353 | 11 | C | ADDERALL XR | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | 10 MG | U | 0 | CAPSULE | |||||||||
| 125183533 | 12518353 | 12 | C | ADDERALL XR | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | 20 MG | U | 0 | CAPSULE | |||||||||
| 125183533 | 12518353 | 13 | C | PROAIR HFA | ALBUTEROL SULFATE | 1 | UNK | U | 0 | INHALER | |||||||||
| 125183533 | 12518353 | 14 | C | ZYRTEC | CETIRIZINE HYDROCHLORIDE | 1 | UNK | U | 0 | ||||||||||
| 125183533 | 12518353 | 15 | C | ZYRTEC | CETIRIZINE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125183533 | 12518353 | 16 | C | PLAQUENIL | HYDROXYCHLOROQUINE SULFATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125183533 | 12518353 | 17 | C | DULERA | FORMOTEROL FUMARATE DIHYDRATEMOMETASONE FUROATE | 1 | UNK | U | 0 | ||||||||||
| 125183533 | 12518353 | 18 | C | QVAR | BECLOMETHASONE DIPROPIONATE | 1 | UNK | U | 0 | INHALER |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125183533 | 12518353 | 1 | Narcolepsy |
| 125183533 | 12518353 | 2 | Cataplexy |
| 125183533 | 12518353 | 3 | Somnolence |
| 125183533 | 12518353 | 5 | Asthma |
| 125183533 | 12518353 | 6 | Hypersensitivity |
| 125183533 | 12518353 | 7 | Product used for unknown indication |
| 125183533 | 12518353 | 8 | Product used for unknown indication |
| 125183533 | 12518353 | 9 | Gastrooesophageal reflux disease |
| 125183533 | 12518353 | 10 | Product used for unknown indication |
| 125183533 | 12518353 | 11 | Narcolepsy |
| 125183533 | 12518353 | 13 | Asthma |
| 125183533 | 12518353 | 14 | Hypersensitivity |
| 125183533 | 12518353 | 15 | Hypersensitivity |
| 125183533 | 12518353 | 16 | Product used for unknown indication |
| 125183533 | 12518353 | 17 | Product used for unknown indication |
| 125183533 | 12518353 | 18 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125183533 | 12518353 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125183533 | 12518353 | Autoimmune disorder | |
| 125183533 | 12518353 | Carpal tunnel syndrome | |
| 125183533 | 12518353 | Condition aggravated | |
| 125183533 | 12518353 | Dizziness | |
| 125183533 | 12518353 | Gastritis | |
| 125183533 | 12518353 | Haematoma | |
| 125183533 | 12518353 | Insomnia | |
| 125183533 | 12518353 | Oesophageal disorder | |
| 125183533 | 12518353 | Pain in extremity | |
| 125183533 | 12518353 | Peripheral swelling | |
| 125183533 | 12518353 | Systemic lupus erythematosus | |
| 125183533 | 12518353 | Vertigo |
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 |
|---|---|---|---|---|---|---|
| 125183533 | 12518353 | 1 | 20110211 | 201104 | 0 | |
| 125183533 | 12518353 | 2 | 201104 | 2015 | 0 | |
| 125183533 | 12518353 | 3 | 201509 | 0 | ||
| 125183533 | 12518353 | 4 | 201509 | 0 | ||
| 125183533 | 12518353 | 5 | 20150928 | 0 | ||
| 125183533 | 12518353 | 7 | 20120808 | 0 | ||
| 125183533 | 12518353 | 8 | 20010101 | 20150927 | 0 | |
| 125183533 | 12518353 | 9 | 20150928 | 0 | ||
| 125183533 | 12518353 | 10 | 20010101 | 20150927 | 0 | |
| 125183533 | 12518353 | 11 | 20010101 | 0 | ||
| 125183533 | 12518353 | 12 | 20150928 | 0 | ||
| 125183533 | 12518353 | 13 | 20150928 | 0 | ||
| 125183533 | 12518353 | 14 | 20150928 | 0 | ||
| 125183533 | 12518353 | 15 | 20010101 | 20150927 | 0 | |
| 125183533 | 12518353 | 16 | 201606 | 0 | ||
| 125183533 | 12518353 | 17 | 20120808 | 20150927 | 0 | |
| 125183533 | 12518353 | 18 | 20010101 | 20150927 | 0 |