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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127144661 | 12714466 | 1 | I | 20160510 | 20160905 | 20160905 | PER | US-JAZZ-2016-US-008770 | JAZZ | 0.00 | M | Y | 0.00000 | 20160905 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127144661 | 12714466 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | 21196 | 2.25 | G | ORAL SOLUTION | |||||||
| 127144661 | 12714466 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | 21196 | ORAL SOLUTION | |||||||||
| 127144661 | 12714466 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | 21196 | 4.5 | G | ORAL SOLUTION | |||||||
| 127144661 | 12714466 | 4 | SS | KLONOPIN | CLONAZEPAM | 1 | U | 0 | |||||||||||
| 127144661 | 12714466 | 5 | SS | ZANTAC | RANITIDINE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 127144661 | 12714466 | 6 | SS | Vitamins | VITAMINS | 1 | N | 0 | |||||||||||
| 127144661 | 12714466 | 7 | C | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | U | 0 | |||||||||||
| 127144661 | 12714466 | 8 | C | BENTYL | DICYCLOMINE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 127144661 | 12714466 | 9 | C | PERCOCET | ACETAMINOPHENOXYCODONE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 127144661 | 12714466 | 10 | C | PREVACID | LANSOPRAZOLE | 1 | U | 0 | |||||||||||
| 127144661 | 12714466 | 11 | C | Hydrocodone/acetaminophen | ACETAMINOPHENHYDROCODONE | 1 | U | 0 | |||||||||||
| 127144661 | 12714466 | 12 | C | L-tryptophan | TRYPTOPHAN | 1 | U | 0 | |||||||||||
| 127144661 | 12714466 | 13 | C | LYRICA | PREGABALIN | 1 | U | 0 | |||||||||||
| 127144661 | 12714466 | 14 | C | OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHENOXYCODONE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 127144661 | 12714466 | 15 | C | Valerian root | VALERIAN | 1 | U | 0 | |||||||||||
| 127144661 | 12714466 | 16 | C | CREON | PANCRELIPASE AMYLASEPANCRELIPASE LIPASEPANCRELIPASE PROTEASE | 1 | U | 0 | |||||||||||
| 127144661 | 12714466 | 17 | C | OMEPRAZOLE DR | OMEPRAZOLE | 1 | U | 0 | |||||||||||
| 127144661 | 12714466 | 18 | C | RITALIN | METHYLPHENIDATE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 127144661 | 12714466 | 19 | C | CYMBALTA | DULOXETINE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 127144661 | 12714466 | 20 | C | 5-htp | OXITRIPTAN | 1 | U | 0 | |||||||||||
| 127144661 | 12714466 | 21 | C | ACIDOPHILUS | LACTOBACILLUS ACIDOPHILUS | 1 | U | 0 | |||||||||||
| 127144661 | 12714466 | 22 | C | ADDERALL XR | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | U | 0 | |||||||||||
| 127144661 | 12714466 | 23 | C | ANDROGEL | TESTOSTERONE | 1 | U | 0 | |||||||||||
| 127144661 | 12714466 | 24 | C | CELEXA | CITALOPRAM HYDROBROMIDE | 1 | U | 0 | |||||||||||
| 127144661 | 12714466 | 25 | C | Magnesium gluconate | MAGNESIUM GLUCONATE | 1 | U | 0 | |||||||||||
| 127144661 | 12714466 | 26 | C | METHADONE | METHADONE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 127144661 | 12714466 | 27 | C | Multivitamins with iron | IRONVITAMINS | 1 | U | 0 | |||||||||||
| 127144661 | 12714466 | 28 | C | RISPERDAL | RISPERIDONE | 1 | U | 0 | |||||||||||
| 127144661 | 12714466 | 29 | C | Stress | 2 | U | 0 | ||||||||||||
| 127144661 | 12714466 | 30 | C | TERAZOSIN | TERAZOSINTERAZOSIN HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 127144661 | 12714466 | 31 | C | Vitamin a | VITAMIN A | 1 | U | 0 | |||||||||||
| 127144661 | 12714466 | 32 | C | Vitamin b | VITAMIN B | 1 | U | 0 | |||||||||||
| 127144661 | 12714466 | 33 | C | VITAMIN D | CHOLECALCIFEROL | 1 | U | 0 | |||||||||||
| 127144661 | 12714466 | 34 | C | VITAMIN E | .ALPHA.-TOCOPHEROL | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127144661 | 12714466 | 1 | Narcolepsy |
| 127144661 | 12714466 | 4 | Product used for unknown indication |
| 127144661 | 12714466 | 5 | Product used for unknown indication |
| 127144661 | 12714466 | 6 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127144661 | 12714466 | Asthenia | |
| 127144661 | 12714466 | Memory impairment | |
| 127144661 | 12714466 | Peripheral coldness | |
| 127144661 | 12714466 | Therapeutic response 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 |
|---|---|---|---|---|---|---|
| 127144661 | 12714466 | 1 | 200811 | 200901 | 0 | |
| 127144661 | 12714466 | 3 | 201010 | 0 |