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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124944392 | 12494439 | 2 | F | 20160629 | 20160623 | 20160707 | EXP | US-JAZZ-2016-US-011271 | JAZZ | 0.00 | F | Y | 0.00000 | 20160707 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124944392 | 12494439 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | 21196 | 2.25 | G | ORAL SOLUTION | |||||||
| 124944392 | 12494439 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | 21196 | 3 | G | ORAL SOLUTION | |||||||
| 124944392 | 12494439 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | 21196 | 4.5 | G | ORAL SOLUTION | |||||||
| 124944392 | 12494439 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | 21196 | 2.25 | G | ORAL SOLUTION | |||||||
| 124944392 | 12494439 | 5 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | 21196 | ORAL SOLUTION | |||||||||
| 124944392 | 12494439 | 6 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | 21196 | 4.5 | G | ORAL SOLUTION | |||||||
| 124944392 | 12494439 | 7 | C | RITALIN | METHYLPHENIDATE HYDROCHLORIDE | 1 | UNK | U | 0 | ||||||||||
| 124944392 | 12494439 | 8 | C | ESTRADIOL. | ESTRADIOL | 1 | UNK | U | 0 | TABLET | |||||||||
| 124944392 | 12494439 | 9 | C | METADATE CD | METHYLPHENIDATE HYDROCHLORIDE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 124944392 | 12494439 | 10 | C | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 124944392 | 12494439 | 11 | C | LORATADINE. | LORATADINE | 1 | UNK | U | 0 | TABLET | |||||||||
| 124944392 | 12494439 | 12 | C | PROTONIX | PANTOPRAZOLE SODIUM | 1 | UNK | U | 0 | TABLET | |||||||||
| 124944392 | 12494439 | 13 | C | DILAUDID | HYDROMORPHONE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 124944392 | 12494439 | 14 | C | MACROBID | NITROFURANTOINNITROFURANTOIN MONOHYDRATE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 124944392 | 12494439 | 15 | C | NUVIGIL | ARMODAFINIL | 1 | UNK | U | 0 | TABLET | |||||||||
| 124944392 | 12494439 | 16 | C | ADDERALL | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | UNK | U | 0 | ||||||||||
| 124944392 | 12494439 | 17 | C | Cetirizine hcl | CETIRIZINE HYDROCHLORIDE | 1 | U | 0 | TABLET | ||||||||||
| 124944392 | 12494439 | 18 | C | CONCERTA | METHYLPHENIDATE HYDROCHLORIDE | 1 | UNK | U | 0 | ||||||||||
| 124944392 | 12494439 | 19 | C | FOLIC ACID. | FOLIC ACID | 1 | U | 0 | TABLET | ||||||||||
| 124944392 | 12494439 | 20 | C | HYDROCODONE | HYDROCODONE | 1 | UNK | U | 0 | ||||||||||
| 124944392 | 12494439 | 21 | C | Multiple vitamins | VITAMINS | 1 | U | 0 | TABLET | ||||||||||
| 124944392 | 12494439 | 22 | C | OMEGA-3 ACIDS | OMEGA-3 FATTY ACIDS | 1 | U | 0 | |||||||||||
| 124944392 | 12494439 | 23 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | U | 0 | CAPSULE | ||||||||||
| 124944392 | 12494439 | 24 | C | VITAMIN D | CHOLECALCIFEROL | 1 | U | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124944392 | 12494439 | 1 | Narcolepsy |
| 124944392 | 12494439 | 7 | Product used for unknown indication |
| 124944392 | 12494439 | 8 | Menopause |
| 124944392 | 12494439 | 9 | Product used for unknown indication |
| 124944392 | 12494439 | 10 | Product used for unknown indication |
| 124944392 | 12494439 | 11 | Product used for unknown indication |
| 124944392 | 12494439 | 12 | Product used for unknown indication |
| 124944392 | 12494439 | 13 | Product used for unknown indication |
| 124944392 | 12494439 | 14 | Product used for unknown indication |
| 124944392 | 12494439 | 15 | Product used for unknown indication |
| 124944392 | 12494439 | 16 | Product used for unknown indication |
| 124944392 | 12494439 | 17 | Product used for unknown indication |
| 124944392 | 12494439 | 18 | Product used for unknown indication |
| 124944392 | 12494439 | 19 | Product used for unknown indication |
| 124944392 | 12494439 | 20 | Product used for unknown indication |
| 124944392 | 12494439 | 21 | Product used for unknown indication |
| 124944392 | 12494439 | 22 | Product used for unknown indication |
| 124944392 | 12494439 | 23 | Product used for unknown indication |
| 124944392 | 12494439 | 24 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124944392 | 12494439 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124944392 | 12494439 | Choking | |
| 124944392 | 12494439 | Fall | |
| 124944392 | 12494439 | Gastrointestinal pain | |
| 124944392 | 12494439 | Intestinal haemorrhage | |
| 124944392 | 12494439 | Therapeutic response unexpected | |
| 124944392 | 12494439 | Weight fluctuation | |
| 124944392 | 12494439 | 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 |
|---|---|---|---|---|---|---|
| 124944392 | 12494439 | 1 | 201003 | 201004 | 0 | |
| 124944392 | 12494439 | 2 | 201004 | 201005 | 0 | |
| 124944392 | 12494439 | 3 | 201005 | 2010 | 0 | |
| 124944392 | 12494439 | 4 | 201105 | 201105 | 0 | |
| 124944392 | 12494439 | 5 | 201105 | 201207 | 0 | |
| 124944392 | 12494439 | 6 | 201207 | 0 | ||
| 124944392 | 12494439 | 7 | 20140626 | 0 | ||
| 124944392 | 12494439 | 8 | 20160608 | 0 | ||
| 124944392 | 12494439 | 9 | 201602 | 0 | ||
| 124944392 | 12494439 | 10 | 201602 | 0 | ||
| 124944392 | 12494439 | 11 | 20141219 | 201606 | 0 | |
| 124944392 | 12494439 | 12 | 20141219 | 201606 | 0 | |
| 124944392 | 12494439 | 13 | 20141209 | 20141219 | 0 | |
| 124944392 | 12494439 | 14 | 20141209 | 20141219 | 0 | |
| 124944392 | 12494439 | 15 | 20140626 | 201606 | 0 | |
| 124944392 | 12494439 | 16 | 201606 | 0 | ||
| 124944392 | 12494439 | 18 | 201606 | 0 | ||
| 124944392 | 12494439 | 20 | 201606 | 0 |