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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123228054 | 12322805 | 4 | F | 2014 | 20160909 | 20160502 | 20160916 | EXP | US-JAZZ-2016-US-007660 | JAZZ | 0.00 | F | Y | 0.00000 | 20160916 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123228054 | 12322805 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | 21196 | 3 | G | ORAL SOLUTION | |||||||
| 123228054 | 12322805 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | 21196 | ORAL SOLUTION | |||||||||
| 123228054 | 12322805 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | NOTCH LESS THAN 3.75 GRAMS AS HER FIRST DOSE AND TAKES LESS THAN 3.5 GRAMS WITH HER SECOND DOSE | 21196 | ORAL SOLUTION | |||||||||
| 123228054 | 12322805 | 4 | SS | LYRICA | PREGABALIN | 1 | UNK | Y | 0 | CAPSULE | |||||||||
| 123228054 | 12322805 | 5 | C | EPIPEN | EPINEPHRINE | 1 | U | 0 | |||||||||||
| 123228054 | 12322805 | 6 | C | Multivitamin | VITAMINS | 1 | U | 0 | TABLET | ||||||||||
| 123228054 | 12322805 | 7 | C | ACETAMINOPHEN. | ACETAMINOPHEN | 1 | UNK | U | 0 | TABLET | |||||||||
| 123228054 | 12322805 | 8 | C | MOTRIN IB | IBUPROFEN | 1 | UNK | U | 0 | ||||||||||
| 123228054 | 12322805 | 9 | C | EFFEXOR | VENLAFAXINE HYDROCHLORIDE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 123228054 | 12322805 | 10 | C | FOLIC ACID. | FOLIC ACID | 1 | UNK | U | 0 | TABLET | |||||||||
| 123228054 | 12322805 | 11 | C | RITALIN | METHYLPHENIDATE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 123228054 | 12322805 | 12 | C | TEMAZEPAM. | TEMAZEPAM | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 123228054 | 12322805 | 13 | C | VENLAFAXINE HCL | VENLAFAXINE HYDROCHLORIDE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 123228054 | 12322805 | 14 | C | VENTOLIN HFA | ALBUTEROL SULFATE | 1 | UNK | U | 0 | INHALER | |||||||||
| 123228054 | 12322805 | 15 | C | ACETAMINOPHEN AND CODEINE | ACETAMINOPHENCODEINE PHOSPHATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 123228054 | 12322805 | 16 | C | Guaitussin ac | 2 | UNK | U | 0 | LIQUID | ||||||||||
| 123228054 | 12322805 | 17 | C | Ropinirole hcl | ROPINIROLE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 123228054 | 12322805 | 18 | C | Sulfamethoxazole | SULFAMETHOXAZOLE | 1 | UNK | U | 0 | TABLET | |||||||||
| 123228054 | 12322805 | 19 | C | NUVIGIL | ARMODAFINIL | 1 | UNK | U | 0 | TABLET | |||||||||
| 123228054 | 12322805 | 20 | C | ZOLOFT | SERTRALINE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 123228054 | 12322805 | 21 | C | XOPENEX | LEVALBUTEROL HYDROCHLORIDE | 1 | UNK | U | 0 | SOLUTION | |||||||||
| 123228054 | 12322805 | 22 | C | COLACE | DOCUSATE SODIUM | 1 | U | 0 | CAPSULE | ||||||||||
| 123228054 | 12322805 | 23 | C | DIPHENHYDRAMINE. | DIPHENHYDRAMINE | 1 | U | 0 | CAPSULE | ||||||||||
| 123228054 | 12322805 | 24 | C | RANITIDINE. | RANITIDINE | 1 | U | 0 | TABLET | ||||||||||
| 123228054 | 12322805 | 25 | C | NYQUIL COLD AND FLU | ACETAMINOPHENDEXTROMETHORPHAN HYDROBROMIDEDOXYLAMINE SUCCINATE | 1 | UNK | U | 0 | LIQUID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123228054 | 12322805 | 1 | Narcolepsy |
| 123228054 | 12322805 | 2 | Cataplexy |
| 123228054 | 12322805 | 4 | Product used for unknown indication |
| 123228054 | 12322805 | 5 | Product used for unknown indication |
| 123228054 | 12322805 | 6 | Product used for unknown indication |
| 123228054 | 12322805 | 7 | Product used for unknown indication |
| 123228054 | 12322805 | 8 | Product used for unknown indication |
| 123228054 | 12322805 | 9 | Product used for unknown indication |
| 123228054 | 12322805 | 10 | Product used for unknown indication |
| 123228054 | 12322805 | 11 | Product used for unknown indication |
| 123228054 | 12322805 | 12 | Product used for unknown indication |
| 123228054 | 12322805 | 13 | Product used for unknown indication |
| 123228054 | 12322805 | 14 | Product used for unknown indication |
| 123228054 | 12322805 | 15 | Product used for unknown indication |
| 123228054 | 12322805 | 16 | Product used for unknown indication |
| 123228054 | 12322805 | 17 | Product used for unknown indication |
| 123228054 | 12322805 | 18 | Product used for unknown indication |
| 123228054 | 12322805 | 19 | Product used for unknown indication |
| 123228054 | 12322805 | 20 | Product used for unknown indication |
| 123228054 | 12322805 | 21 | Product used for unknown indication |
| 123228054 | 12322805 | 22 | Product used for unknown indication |
| 123228054 | 12322805 | 23 | Product used for unknown indication |
| 123228054 | 12322805 | 24 | Product used for unknown indication |
| 123228054 | 12322805 | 25 | Nasopharyngitis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123228054 | 12322805 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123228054 | 12322805 | Appetite disorder | |
| 123228054 | 12322805 | Insomnia | |
| 123228054 | 12322805 | Intentional product misuse | |
| 123228054 | 12322805 | Medication error | |
| 123228054 | 12322805 | Nasopharyngitis | |
| 123228054 | 12322805 | Oedema | |
| 123228054 | 12322805 | Pain | |
| 123228054 | 12322805 | Seizure | |
| 123228054 | 12322805 | Unevaluable event | |
| 123228054 | 12322805 | Wrong technique in product usage process |
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 |
|---|---|---|---|---|---|---|
| 123228054 | 12322805 | 1 | 201210 | 2012 | 0 | |
| 123228054 | 12322805 | 4 | 2015 | 0 | ||
| 123228054 | 12322805 | 7 | 201601 | 0 | ||
| 123228054 | 12322805 | 8 | 201601 | 0 | ||
| 123228054 | 12322805 | 9 | 20151229 | 0 | ||
| 123228054 | 12322805 | 10 | 20151229 | 0 | ||
| 123228054 | 12322805 | 11 | 20151229 | 0 | ||
| 123228054 | 12322805 | 12 | 20151229 | 0 | ||
| 123228054 | 12322805 | 13 | 20151229 | 201512 | 0 | |
| 123228054 | 12322805 | 14 | 20151229 | 0 | ||
| 123228054 | 12322805 | 15 | 20150107 | 201502 | 0 | |
| 123228054 | 12322805 | 16 | 20150107 | 20150107 | 0 | |
| 123228054 | 12322805 | 17 | 20150107 | 20150107 | 0 | |
| 123228054 | 12322805 | 18 | 20150107 | 201502 | 0 | |
| 123228054 | 12322805 | 19 | 20121021 | 20150107 | 0 | |
| 123228054 | 12322805 | 20 | 20100424 | 201512 | 0 | |
| 123228054 | 12322805 | 21 | 20041001 | 0 | ||
| 123228054 | 12322805 | 25 | 201604 | 0 |