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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123700212 | 12370021 | 2 | F | 2016 | 20160718 | 20160516 | 20160725 | EXP | US-JAZZ-2016-US-005699 | JAZZ | 0.00 | F | Y | 0.00000 | 20160725 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123700212 | 12370021 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | N | 21196 | 3 | G | ORAL SOLUTION | ||||||
| 123700212 | 12370021 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.75 G, BID | N | 21196 | 3.75 | G | ORAL SOLUTION | ||||||
| 123700212 | 12370021 | 3 | SS | DIFLUCAN | FLUCONAZOLE | 1 | UNKNOWN DOSE | U | 0 | ||||||||||
| 123700212 | 12370021 | 4 | SS | FLAGYL | METRONIDAZOLEMETRONIDAZOLE HYDROCHLORIDE | 1 | UNKNOWN DOSE | U | 0 | ||||||||||
| 123700212 | 12370021 | 5 | SS | PLAQUENIL | HYDROXYCHLOROQUINE SULFATE | 1 | U | 0 | TABLET | ||||||||||
| 123700212 | 12370021 | 6 | C | ADDERALL | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 123700212 | 12370021 | 7 | C | BENADRYL ALLERGY | DIPHENHYDRAMINE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 123700212 | 12370021 | 8 | C | Cyclobenzaprine | CYCLOBENZAPRINE | 1 | U | 0 | TABLET | ||||||||||
| 123700212 | 12370021 | 9 | C | CYMBALTA | DULOXETINE HYDROCHLORIDE | 1 | U | 0 | CAPSULE | ||||||||||
| 123700212 | 12370021 | 10 | C | DOCUSATE SODIUM. | DOCUSATE SODIUM | 1 | U | 0 | CAPSULE | ||||||||||
| 123700212 | 12370021 | 11 | C | FOLIC ACID. | FOLIC ACID | 1 | U | 0 | TABLET | ||||||||||
| 123700212 | 12370021 | 12 | C | NAPROXEN. | NAPROXEN | 1 | U | 0 | TABLET | ||||||||||
| 123700212 | 12370021 | 13 | C | NIFEDIPINE. | NIFEDIPINE | 1 | U | 0 | TABLET | ||||||||||
| 123700212 | 12370021 | 14 | C | OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHENOXYCODONE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 123700212 | 12370021 | 15 | C | TRAMADOL HCL | TRAMADOL HYDROCHLORIDE | 1 | U | 0 | TABLET | ||||||||||
| 123700212 | 12370021 | 16 | C | TRAZODONE | TRAZODONE HYDROCHLORIDE | 1 | U | 0 | TABLET | ||||||||||
| 123700212 | 12370021 | 17 | C | VITAMIN D3 | CHOLECALCIFEROL | 1 | U | 0 | CAPSULE | ||||||||||
| 123700212 | 12370021 | 18 | C | ADDERALL | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | U | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123700212 | 12370021 | 1 | Narcolepsy |
| 123700212 | 12370021 | 2 | Cataplexy |
| 123700212 | 12370021 | 3 | Fungal infection |
| 123700212 | 12370021 | 4 | Fungal infection |
| 123700212 | 12370021 | 5 | Product used for unknown indication |
| 123700212 | 12370021 | 6 | Product used for unknown indication |
| 123700212 | 12370021 | 7 | Product used for unknown indication |
| 123700212 | 12370021 | 8 | Product used for unknown indication |
| 123700212 | 12370021 | 9 | Product used for unknown indication |
| 123700212 | 12370021 | 10 | Product used for unknown indication |
| 123700212 | 12370021 | 11 | Product used for unknown indication |
| 123700212 | 12370021 | 12 | Product used for unknown indication |
| 123700212 | 12370021 | 13 | Product used for unknown indication |
| 123700212 | 12370021 | 14 | Product used for unknown indication |
| 123700212 | 12370021 | 15 | Product used for unknown indication |
| 123700212 | 12370021 | 16 | Product used for unknown indication |
| 123700212 | 12370021 | 17 | Product used for unknown indication |
| 123700212 | 12370021 | 18 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123700212 | 12370021 | HO |
| 123700212 | 12370021 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123700212 | 12370021 | Ankylosing spondylitis | |
| 123700212 | 12370021 | Back disorder | |
| 123700212 | 12370021 | Bacterial vaginosis | |
| 123700212 | 12370021 | Fungal infection | |
| 123700212 | 12370021 | Hypoaesthesia | |
| 123700212 | 12370021 | Muscle atrophy | |
| 123700212 | 12370021 | Muscle spasticity | |
| 123700212 | 12370021 | Nail disorder | |
| 123700212 | 12370021 | Nerve injury | |
| 123700212 | 12370021 | Oedema | |
| 123700212 | 12370021 | Panic attack | |
| 123700212 | 12370021 | Peroneal nerve palsy | |
| 123700212 | 12370021 | Rash macular | |
| 123700212 | 12370021 | Skin discolouration | |
| 123700212 | 12370021 | Skin exfoliation | |
| 123700212 | 12370021 | Skin wrinkling | |
| 123700212 | 12370021 | Urticaria | |
| 123700212 | 12370021 | 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 |
|---|---|---|---|---|---|---|
| 123700212 | 12370021 | 1 | 201603 | 2016 | 0 | |
| 123700212 | 12370021 | 2 | 2016 | 0 | ||
| 123700212 | 12370021 | 6 | 201601 | 0 |