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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125580851 | 12558085 | 1 | I | 201512 | 20160113 | 20160714 | 20160714 | PER | US-JAZZ-2016-US-000662 | JAZZ | 28.39 | YR | F | Y | 0.00000 | 20160714 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125580851 | 12558085 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | 21196 | 2.25 | G | ORAL SOLUTION | |||||||
| 125580851 | 12558085 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.75 G, BID | 21196 | 3.75 | G | ORAL SOLUTION | |||||||
| 125580851 | 12558085 | 3 | SS | NUVIGIL | ARMODAFINIL | 1 | UNK | Y | 0 | TABLET | |||||||||
| 125580851 | 12558085 | 4 | C | DIAZEPAM. | DIAZEPAM | 1 | UNK | U | 0 | TABLET | |||||||||
| 125580851 | 12558085 | 5 | C | Doxepin | DOXEPIN | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 125580851 | 12558085 | 6 | C | EFFEXOR | VENLAFAXINE HYDROCHLORIDE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 125580851 | 12558085 | 7 | C | IMITREX | SUMATRIPTAN SUCCINATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125580851 | 12558085 | 8 | C | LAMICTAL | LAMOTRIGINE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125580851 | 12558085 | 9 | C | LINZESS | LINACLOTIDE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 125580851 | 12558085 | 10 | C | Multi vitamin | VITAMINS | 1 | UNK | U | 0 | ||||||||||
| 125580851 | 12558085 | 11 | C | SINGULAIR | MONTELUKAST SODIUM | 1 | UNK | U | 0 | TABLET | |||||||||
| 125580851 | 12558085 | 12 | C | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | UNK | U | 0 | INHALER | |||||||||
| 125580851 | 12558085 | 13 | C | VENTOLIN HFA | ALBUTEROL SULFATE | 1 | UNK | U | 0 | INHALER | |||||||||
| 125580851 | 12558085 | 14 | C | VOLTAREN | DICLOFENAC SODIUM | 1 | UNK | U | 0 | GEL | |||||||||
| 125580851 | 12558085 | 15 | C | VALIUM | DIAZEPAM | 1 | U | 0 | |||||||||||
| 125580851 | 12558085 | 16 | C | SEASONIQUE | ETHINYL ESTRADIOLLEVONORGESTREL | 1 | U | 0 | |||||||||||
| 125580851 | 12558085 | 17 | C | MAXALT | RIZATRIPTAN BENZOATE | 1 | U | 0 | |||||||||||
| 125580851 | 12558085 | 18 | C | PROPRANOLOL | PROPRANOLOLPROPRANOLOL HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 125580851 | 12558085 | 19 | C | DULERA | FORMOTEROL FUMARATE DIHYDRATEMOMETASONE FUROATE | 1 | U | 0 | |||||||||||
| 125580851 | 12558085 | 20 | C | ALBUTEROL. | ALBUTEROL | 1 | U | 0 | |||||||||||
| 125580851 | 12558085 | 21 | C | PEPPERMINT. | PEPPERMINT | 1 | U | 0 | |||||||||||
| 125580851 | 12558085 | 22 | C | CLARITIN | LORATADINE | 1 | U | 0 | |||||||||||
| 125580851 | 12558085 | 23 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | U | 0 | |||||||||||
| 125580851 | 12558085 | 24 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125580851 | 12558085 | 1 | Product used for unknown indication |
| 125580851 | 12558085 | 3 | Product used for unknown indication |
| 125580851 | 12558085 | 4 | Product used for unknown indication |
| 125580851 | 12558085 | 5 | Product used for unknown indication |
| 125580851 | 12558085 | 6 | Product used for unknown indication |
| 125580851 | 12558085 | 7 | Product used for unknown indication |
| 125580851 | 12558085 | 8 | Product used for unknown indication |
| 125580851 | 12558085 | 9 | Product used for unknown indication |
| 125580851 | 12558085 | 10 | Product used for unknown indication |
| 125580851 | 12558085 | 11 | Product used for unknown indication |
| 125580851 | 12558085 | 12 | Hypersensitivity |
| 125580851 | 12558085 | 13 | Product used for unknown indication |
| 125580851 | 12558085 | 14 | Product used for unknown indication |
| 125580851 | 12558085 | 17 | Migraine |
| 125580851 | 12558085 | 18 | Migraine |
| 125580851 | 12558085 | 23 | Gastrooesophageal reflux disease |
| 125580851 | 12558085 | 24 | Nausea |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125580851 | 12558085 | Bronchitis | |
| 125580851 | 12558085 | Condition aggravated | |
| 125580851 | 12558085 | Ear infection | |
| 125580851 | 12558085 | Hyperhidrosis | |
| 125580851 | 12558085 | Intentional product use issue | |
| 125580851 | 12558085 | Migraine | |
| 125580851 | 12558085 | Pre-existing condition improved | |
| 125580851 | 12558085 | Sinusitis | |
| 125580851 | 12558085 | Stress | |
| 125580851 | 12558085 | Therapeutic response unexpected |
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 |
|---|---|---|---|---|---|---|
| 125580851 | 12558085 | 1 | 201512 | 201601 | 0 | |
| 125580851 | 12558085 | 2 | 201601 | 0 | ||
| 125580851 | 12558085 | 3 | 20151223 | 0 | ||
| 125580851 | 12558085 | 4 | 20151223 | 0 | ||
| 125580851 | 12558085 | 5 | 20151223 | 0 | ||
| 125580851 | 12558085 | 6 | 20151223 | 0 | ||
| 125580851 | 12558085 | 7 | 20151223 | 0 | ||
| 125580851 | 12558085 | 8 | 20151223 | 0 | ||
| 125580851 | 12558085 | 9 | 20151223 | 0 | ||
| 125580851 | 12558085 | 10 | 20151223 | 0 | ||
| 125580851 | 12558085 | 11 | 20151223 | 0 | ||
| 125580851 | 12558085 | 12 | 20151223 | 0 | ||
| 125580851 | 12558085 | 13 | 20151223 | 0 | ||
| 125580851 | 12558085 | 14 | 20151223 | 0 |