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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126509311 | 12650931 | 1 | I | 201503 | 20160315 | 20160815 | 20160815 | PER | US-JAZZ-2016-US-005139 | JAZZ | 38.40 | YR | F | Y | 0.00000 | 20160815 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126509311 | 12650931 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | U | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 126509311 | 12650931 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | U | 21196 | ORAL SOLUTION | ||||||||
| 126509311 | 12650931 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | U | 21196 | 4.5 | G | ORAL SOLUTION | ||||||
| 126509311 | 12650931 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | U | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 126509311 | 12650931 | 5 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | U | 21196 | 3 | G | ORAL SOLUTION | ||||||
| 126509311 | 12650931 | 6 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.75 G, BID | U | 21196 | 3.75 | G | ORAL SOLUTION | ||||||
| 126509311 | 12650931 | 7 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | U | 21196 | 4.5 | G | ORAL SOLUTION | ||||||
| 126509311 | 12650931 | 8 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | U | 21196 | 4.5 | G | ORAL SOLUTION | ||||||
| 126509311 | 12650931 | 9 | SS | MECLIZINE | MECLIZINE HYDROCHLORIDE | 1 | UNK | U | 0 | ||||||||||
| 126509311 | 12650931 | 10 | SS | TIZANIDINE. | TIZANIDINE | 1 | U | 0 | |||||||||||
| 126509311 | 12650931 | 11 | SS | GABAPENTIN. | GABAPENTIN | 1 | U | 0 | |||||||||||
| 126509311 | 12650931 | 12 | C | NAPROXEN. | NAPROXEN | 1 | U | 0 | |||||||||||
| 126509311 | 12650931 | 13 | C | NEURONTIN | GABAPENTIN | 1 | U | 0 | |||||||||||
| 126509311 | 12650931 | 14 | C | EFFEXOR | VENLAFAXINE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 126509311 | 12650931 | 15 | C | BACLOFEN. | BACLOFEN | 1 | U | 0 | |||||||||||
| 126509311 | 12650931 | 16 | C | MELOXICAM. | MELOXICAM | 1 | U | 0 | |||||||||||
| 126509311 | 12650931 | 17 | C | Amphetamine salts | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | U | 0 | |||||||||||
| 126509311 | 12650931 | 18 | C | BENADRYL ALLERGY | DIPHENHYDRAMINE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 126509311 | 12650931 | 19 | C | Black cohosh | BLACK COHOSH | 1 | U | 0 | |||||||||||
| 126509311 | 12650931 | 20 | C | Calcium +D | CALCIUMVITAMIN D | 1 | U | 0 | |||||||||||
| 126509311 | 12650931 | 21 | C | CLARITIN | LORATADINE | 1 | U | 0 | |||||||||||
| 126509311 | 12650931 | 22 | C | DIAZEPAM. | DIAZEPAM | 1 | U | 0 | |||||||||||
| 126509311 | 12650931 | 23 | C | IBUPROFEN. | IBUPROFEN | 1 | U | 0 | |||||||||||
| 126509311 | 12650931 | 24 | C | IMITREX | SUMATRIPTAN SUCCINATE | 1 | U | 0 | |||||||||||
| 126509311 | 12650931 | 25 | C | Metformin hcl | METFORMIN HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 126509311 | 12650931 | 26 | C | MOVANTIK | NALOXEGOL OXALATE | 1 | U | 0 | |||||||||||
| 126509311 | 12650931 | 27 | C | NASACORT | TRIAMCINOLONE ACETONIDE | 1 | U | 0 | |||||||||||
| 126509311 | 12650931 | 28 | C | NUVIGIL | ARMODAFINIL | 1 | U | 0 | |||||||||||
| 126509311 | 12650931 | 29 | C | Ondansetron hcl | ONDANSETRON HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 126509311 | 12650931 | 30 | C | Tizanidine Hcl | TIZANIDINE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 126509311 | 12650931 | 31 | C | TRAMADOL HCL | TRAMADOL HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 126509311 | 12650931 | 32 | C | TYLENOL EXTRA STRENGTH | ACETAMINOPHEN | 1 | U | 0 | |||||||||||
| 126509311 | 12650931 | 33 | C | LYRICA | PREGABALIN | 1 | U | 0 | |||||||||||
| 126509311 | 12650931 | 34 | C | NORCO | ACETAMINOPHENHYDROCODONE BITARTRATE | 1 | U | 0 | |||||||||||
| 126509311 | 12650931 | 35 | C | Multivitamins | VITAMINS | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126509311 | 12650931 | 1 | Narcolepsy |
| 126509311 | 12650931 | 2 | Cataplexy |
| 126509311 | 12650931 | 9 | Product used for unknown indication |
| 126509311 | 12650931 | 10 | Product used for unknown indication |
| 126509311 | 12650931 | 11 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126509311 | 12650931 | Bradycardia | |
| 126509311 | 12650931 | Cataplexy | |
| 126509311 | 12650931 | Constipation | |
| 126509311 | 12650931 | Deafness unilateral | |
| 126509311 | 12650931 | Drug interaction | |
| 126509311 | 12650931 | Fatigue | |
| 126509311 | 12650931 | Neuralgia | |
| 126509311 | 12650931 | Occipital neuralgia | |
| 126509311 | 12650931 | Vertigo | |
| 126509311 | 12650931 | 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 |
|---|---|---|---|---|---|---|
| 126509311 | 12650931 | 1 | 200701 | 200705 | 0 | |
| 126509311 | 12650931 | 3 | 200802 | 2008 | 0 | |
| 126509311 | 12650931 | 4 | 201003 | 2010 | 0 | |
| 126509311 | 12650931 | 5 | 201104 | 201105 | 0 | |
| 126509311 | 12650931 | 6 | 201105 | 2011 | 0 | |
| 126509311 | 12650931 | 7 | 2011 | 2013 | 0 | |
| 126509311 | 12650931 | 8 | 201311 | 0 | ||
| 126509311 | 12650931 | 9 | 20140424 | 0 |