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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127090941 | 12709094 | 1 | I | 20160505 | 20160901 | 20160901 | PER | US-JAZZ-2016-US-008529 | JAZZ | 0.00 | F | Y | 0.00000 | 20160901 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127090941 | 12709094 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 4 G, FIRST DOSE | U | 21196 | 4 | G | ORAL SOLUTION | ||||||
| 127090941 | 12709094 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 2 G, SECOND DOSE | U | 21196 | 2 | G | ORAL SOLUTION | ||||||
| 127090941 | 12709094 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 6 G, FIRST DOSE | U | 21196 | 6 | G | ORAL SOLUTION | ||||||
| 127090941 | 12709094 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, SECOND DOSE | U | 21196 | 3 | G | ORAL SOLUTION | ||||||
| 127090941 | 12709094 | 5 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 6 G, FIRST DOSE | U | 21196 | 6 | G | ORAL SOLUTION | ||||||
| 127090941 | 12709094 | 6 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, SECOND SOE | U | 21196 | 3 | G | ORAL SOLUTION | ||||||
| 127090941 | 12709094 | 7 | SS | PREMARIN | ESTROGENS, CONJUGATED | 1 | Unknown | 0.3 MG, | U | 0 | .3 | MG | TABLET | ||||||
| 127090941 | 12709094 | 8 | SS | PREMARIN | ESTROGENS, CONJUGATED | 1 | Unknown | 0.625 MG | U | 0 | .625 | MG | TABLET | ||||||
| 127090941 | 12709094 | 9 | C | ULTRAM | TRAMADOL HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 127090941 | 12709094 | 10 | C | LANTUS | INSULIN GLARGINE | 1 | U | 0 | |||||||||||
| 127090941 | 12709094 | 11 | C | HUMALOG | INSULIN LISPRO | 1 | U | 0 | |||||||||||
| 127090941 | 12709094 | 12 | C | LIDODERM | LIDOCAINE | 1 | U | 0 | |||||||||||
| 127090941 | 12709094 | 13 | C | LISINOPRIL. | LISINOPRIL | 1 | U | 0 | |||||||||||
| 127090941 | 12709094 | 14 | C | Metformin hcl | METFORMIN HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 127090941 | 12709094 | 15 | C | NOVOLOG | INSULIN ASPART | 1 | U | 0 | |||||||||||
| 127090941 | 12709094 | 16 | C | Black cohosh extract | 2 | U | 0 | ||||||||||||
| 127090941 | 12709094 | 17 | C | Amphetamine | AMPHETAMINE | 1 | U | 0 | |||||||||||
| 127090941 | 12709094 | 18 | C | Multivitamins | VITAMINS | 1 | U | 0 | |||||||||||
| 127090941 | 12709094 | 19 | C | ADDERALL | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | U | 0 | |||||||||||
| 127090941 | 12709094 | 20 | C | ESTRADIOL. | ESTRADIOL | 1 | U | 0 | |||||||||||
| 127090941 | 12709094 | 21 | C | FLEXERIL | CYCLOBENZAPRINE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 127090941 | 12709094 | 22 | C | KLONOPIN | CLONAZEPAM | 1 | U | 0 | |||||||||||
| 127090941 | 12709094 | 23 | C | MIRALAX | POLYETHYLENE GLYCOL 3350 | 1 | U | 0 | |||||||||||
| 127090941 | 12709094 | 24 | C | MOVANTIK | NALOXEGOL OXALATE | 1 | U | 0 | |||||||||||
| 127090941 | 12709094 | 25 | C | BROMFED | BROMPHENIRAMINE MALEATEDEXTROMETHORPHAN HYDROBROMIDEPSEUDOEPHEDRINE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 127090941 | 12709094 | 26 | C | TAMIFLU | OSELTAMIVIR PHOSPHATE | 1 | U | 0 | |||||||||||
| 127090941 | 12709094 | 27 | C | Methadone hcl | METHADONE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 127090941 | 12709094 | 28 | C | SIMVASTATIN. | SIMVASTATIN | 1 | U | 0 | |||||||||||
| 127090941 | 12709094 | 29 | C | NEURONTIN | GABAPENTIN | 1 | U | 0 | |||||||||||
| 127090941 | 12709094 | 30 | C | DURAGESIC | FENTANYL | 1 | U | 0 | |||||||||||
| 127090941 | 12709094 | 31 | C | AMBIEN | ZOLPIDEM TARTRATE | 1 | U | 0 | |||||||||||
| 127090941 | 12709094 | 32 | C | LYRICA | PREGABALIN | 1 | U | 0 | |||||||||||
| 127090941 | 12709094 | 33 | C | CLONIDINE. | CLONIDINE | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127090941 | 12709094 | 1 | Narcolepsy |
| 127090941 | 12709094 | 7 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127090941 | 12709094 | Activities of daily living impaired | |
| 127090941 | 12709094 | Enuresis | |
| 127090941 | 12709094 | Intentional product use issue | |
| 127090941 | 12709094 | Myalgia | |
| 127090941 | 12709094 | Pain in extremity |
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 |
|---|---|---|---|---|---|---|
| 127090941 | 12709094 | 1 | 200905 | 200907 | 0 | |
| 127090941 | 12709094 | 2 | 200905 | 200907 | 0 | |
| 127090941 | 12709094 | 3 | 200907 | 0 | ||
| 127090941 | 12709094 | 4 | 200907 | 0 | ||
| 127090941 | 12709094 | 5 | 201406 | 0 | ||
| 127090941 | 12709094 | 6 | 201406 | 0 | ||
| 127090941 | 12709094 | 7 | 20140206 | 20151110 | 0 | |
| 127090941 | 12709094 | 8 | 20141028 | 20151110 | 0 |