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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115334764 | 11533476 | 4 | F | 2007 | 20160627 | 20150921 | 20160706 | EXP | US-JAZZ-2015-US-000703 | JAZZ | 0.00 | F | Y | 66.00000 | KG | 20160706 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115334764 | 11533476 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | U | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 115334764 | 11533476 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | U | 21196 | ORAL SOLUTION | ||||||||
| 115334764 | 11533476 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | U | 21196 | 4.5 | G | ORAL SOLUTION | ||||||
| 115334764 | 11533476 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | U | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 115334764 | 11533476 | 5 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | U | 21196 | ORAL SOLUTION | ||||||||
| 115334764 | 11533476 | 6 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | U | 21196 | 3 | G | ORAL SOLUTION | ||||||
| 115334764 | 11533476 | 7 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | U | 21196 | 4.5 | G | ORAL SOLUTION | ||||||
| 115334764 | 11533476 | 8 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | U | 21196 | 3 | G | ORAL SOLUTION | ||||||
| 115334764 | 11533476 | 9 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | U | 21196 | 4.5 | G | ORAL SOLUTION | ||||||
| 115334764 | 11533476 | 10 | C | LATUDA | LURASIDONE HYDROCHLORIDE | 1 | UNK | U | 0 | ||||||||||
| 115334764 | 11533476 | 11 | C | LATUDA | LURASIDONE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 115334764 | 11533476 | 12 | C | LATUDA | LURASIDONE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 115334764 | 11533476 | 13 | C | LATUDA | LURASIDONE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 115334764 | 11533476 | 14 | C | LATUDA | LURASIDONE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 115334764 | 11533476 | 15 | C | BOTOX | ONABOTULINUMTOXINA | 1 | UNK | U | 0 | ||||||||||
| 115334764 | 11533476 | 16 | C | KLONOPIN | CLONAZEPAM | 1 | U | 0 | |||||||||||
| 115334764 | 11533476 | 17 | C | IMITREX | SUMATRIPTAN SUCCINATE | 1 | AS NEEDED | U | 0 | INJECTION | |||||||||
| 115334764 | 11533476 | 18 | C | PRISTIQ EXTENDED-RELEASE | DESVENLAFAXINE SUCCINATE | 1 | U | 0 | |||||||||||
| 115334764 | 11533476 | 19 | C | PRISTIQ EXTENDED-RELEASE | DESVENLAFAXINE SUCCINATE | 1 | U | 0 | |||||||||||
| 115334764 | 11533476 | 20 | C | PRISTIQ EXTENDED-RELEASE | DESVENLAFAXINE SUCCINATE | 1 | U | 0 | |||||||||||
| 115334764 | 11533476 | 21 | C | PRISTIQ EXTENDED-RELEASE | DESVENLAFAXINE SUCCINATE | 1 | U | 0 | |||||||||||
| 115334764 | 11533476 | 22 | C | XANAX | ALPRAZOLAM | 1 | U | 0 | |||||||||||
| 115334764 | 11533476 | 23 | C | XANAX | ALPRAZOLAM | 1 | U | 0 | |||||||||||
| 115334764 | 11533476 | 24 | C | XANAX | ALPRAZOLAM | 1 | U | 0 | |||||||||||
| 115334764 | 11533476 | 25 | C | XANAX | ALPRAZOLAM | 1 | U | 0 | |||||||||||
| 115334764 | 11533476 | 26 | C | LAMICTAL | LAMOTRIGINE | 1 | U | 0 | |||||||||||
| 115334764 | 11533476 | 27 | C | LAMICTAL | LAMOTRIGINE | 1 | U | 0 | |||||||||||
| 115334764 | 11533476 | 28 | C | LAMICTAL | LAMOTRIGINE | 1 | U | 0 | |||||||||||
| 115334764 | 11533476 | 29 | C | LAMICTAL | LAMOTRIGINE | 1 | U | 0 | |||||||||||
| 115334764 | 11533476 | 30 | C | ADDERALL | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | U | 0 | |||||||||||
| 115334764 | 11533476 | 31 | C | MIRAPEX | PRAMIPEXOLE DIHYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 115334764 | 11533476 | 32 | C | SINGULAIR | MONTELUKAST SODIUM | 1 | U | 0 | |||||||||||
| 115334764 | 11533476 | 33 | C | SENNA | SENNA LEAFSENNOSIDESSENNOSIDES A AND B | 1 | AS NEEDED | U | 0 | ||||||||||
| 115334764 | 11533476 | 34 | C | PERCOCET | ACETAMINOPHENOXYCODONE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 115334764 | 11533476 | 35 | C | OXYCONTIN | OXYCODONE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 115334764 | 11533476 | 36 | C | DICYCLOMINE | DICYCLOMINE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 115334764 | 11533476 | 37 | C | Biotin | BIOTIN | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 115334764 | 11533476 | 1 | Narcolepsy |
| 115334764 | 11533476 | 10 | Mental disorder |
| 115334764 | 11533476 | 11 | Bipolar disorder |
| 115334764 | 11533476 | 12 | Major depression |
| 115334764 | 11533476 | 13 | Obsessive-compulsive disorder |
| 115334764 | 11533476 | 14 | Anxiety |
| 115334764 | 11533476 | 15 | Post-traumatic headache |
| 115334764 | 11533476 | 16 | Product used for unknown indication |
| 115334764 | 11533476 | 17 | Migraine |
| 115334764 | 11533476 | 18 | Bipolar disorder |
| 115334764 | 11533476 | 19 | Major depression |
| 115334764 | 11533476 | 20 | Obsessive-compulsive disorder |
| 115334764 | 11533476 | 21 | Anxiety |
| 115334764 | 11533476 | 22 | Bipolar disorder |
| 115334764 | 11533476 | 23 | Major depression |
| 115334764 | 11533476 | 24 | Obsessive-compulsive disorder |
| 115334764 | 11533476 | 25 | Anxiety |
| 115334764 | 11533476 | 26 | Bipolar disorder |
| 115334764 | 11533476 | 27 | Major depression |
| 115334764 | 11533476 | 28 | Obsessive-compulsive disorder |
| 115334764 | 11533476 | 29 | Anxiety |
| 115334764 | 11533476 | 30 | Narcolepsy |
| 115334764 | 11533476 | 31 | Restless legs syndrome |
| 115334764 | 11533476 | 32 | Hypersensitivity |
| 115334764 | 11533476 | 33 | Product used for unknown indication |
| 115334764 | 11533476 | 34 | Pain |
| 115334764 | 11533476 | 35 | Pain |
| 115334764 | 11533476 | 36 | Irritable bowel syndrome |
| 115334764 | 11533476 | 37 | Supplementation therapy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 115334764 | 11533476 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 115334764 | 11533476 | Abdominal hernia | |
| 115334764 | 11533476 | Ankle fracture | |
| 115334764 | 11533476 | Concussion | |
| 115334764 | 11533476 | Contusion | |
| 115334764 | 11533476 | Eye contusion | |
| 115334764 | 11533476 | Eye swelling | |
| 115334764 | 11533476 | Fall | |
| 115334764 | 11533476 | Hepatic enzyme increased | |
| 115334764 | 11533476 | Joint dislocation | |
| 115334764 | 11533476 | Loss of consciousness | |
| 115334764 | 11533476 | Lung perforation | |
| 115334764 | 11533476 | Psychogenic seizure | |
| 115334764 | 11533476 | Rib fracture | |
| 115334764 | 11533476 | Scar | |
| 115334764 | 11533476 | Shoulder operation | |
| 115334764 | 11533476 | Somnambulism | |
| 115334764 | 11533476 | Spinal fracture |
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 |
|---|---|---|---|---|---|---|
| 115334764 | 11533476 | 1 | 200708 | 2007 | 0 | |
| 115334764 | 11533476 | 3 | 2007 | 2007 | 0 | |
| 115334764 | 11533476 | 4 | 201110 | 201110 | 0 | |
| 115334764 | 11533476 | 6 | 201405 | 2015 | 0 | |
| 115334764 | 11533476 | 7 | 2015 | 2015 | 0 | |
| 115334764 | 11533476 | 8 | 2015 | 0 |