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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121698062 | 12169806 | 2 | F | 20160825 | 20160310 | 20160901 | EXP | US-JAZZ-2016-US-004145 | JAZZ | 0.00 | M | Y | 79.37000 | KG | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121698062 | 12169806 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | U | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 121698062 | 12169806 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | U | 21196 | ORAL SOLUTION | ||||||||
| 121698062 | 12169806 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, FIRST DOSE | U | 21196 | 3 | G | ORAL SOLUTION | ||||||
| 121698062 | 12169806 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, SECOND DOSE | U | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 121698062 | 12169806 | 5 | SS | LYRICA | PREGABALIN | 1 | 225 MG, UNK | Y | 0 | 225 | MG | CAPSULE | |||||||
| 121698062 | 12169806 | 6 | SS | LYRICA | PREGABALIN | 1 | 75 MG, UNK | Y | 0 | 75 | MG | CAPSULE | |||||||
| 121698062 | 12169806 | 7 | SS | LYRICA | PREGABALIN | 1 | 100 MG, UNK | Y | 0 | 100 | MG | CAPSULE | |||||||
| 121698062 | 12169806 | 8 | C | FLORINEF ACETATE | FLUDROCORTISONE ACETATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 121698062 | 12169806 | 9 | C | Ery-tab ec | 2 | UNK | U | 0 | TABLET | ||||||||||
| 121698062 | 12169806 | 10 | C | NEXIUM | ESOMEPRAZOLE MAGNESIUM | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 121698062 | 12169806 | 11 | C | XANAX | ALPRAZOLAM | 1 | UNK | U | 0 | TABLET | |||||||||
| 121698062 | 12169806 | 12 | C | Tizanidine Hcl tablet | 2 | UNK | U | 0 | TABLET | ||||||||||
| 121698062 | 12169806 | 13 | C | Tizanidine Hcl capsule | 2 | UNK | U | 0 | CAPSULE | ||||||||||
| 121698062 | 12169806 | 14 | C | BELSOMRA | SUVOREXANT | 1 | UNK | U | 0 | TABLET | |||||||||
| 121698062 | 12169806 | 15 | C | PREVIDENT | SODIUM FLUORIDE | 1 | UNK | U | 0 | ||||||||||
| 121698062 | 12169806 | 16 | C | CEFDINIR. | CEFDINIR | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 121698062 | 12169806 | 17 | C | MARINOL | DRONABINOL | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 121698062 | 12169806 | 18 | C | RESTORIL | TEMAZEPAM | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 121698062 | 12169806 | 19 | C | PROPRANOLOL | PROPRANOLOLPROPRANOLOL HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 121698062 | 12169806 | 20 | C | BUPRENORPHINE. | BUPRENORPHINE | 1 | UNK | U | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 121698062 | 12169806 | 1 | Narcolepsy |
| 121698062 | 12169806 | 5 | Neuralgia |
| 121698062 | 12169806 | 8 | Hypotension |
| 121698062 | 12169806 | 9 | Impaired gastric emptying |
| 121698062 | 12169806 | 10 | Gastrooesophageal reflux disease |
| 121698062 | 12169806 | 11 | Anxiety |
| 121698062 | 12169806 | 12 | Pain |
| 121698062 | 12169806 | 13 | Pain |
| 121698062 | 12169806 | 14 | Product used for unknown indication |
| 121698062 | 12169806 | 15 | Product used for unknown indication |
| 121698062 | 12169806 | 16 | Product used for unknown indication |
| 121698062 | 12169806 | 17 | Product used for unknown indication |
| 121698062 | 12169806 | 18 | Product used for unknown indication |
| 121698062 | 12169806 | 19 | Product used for unknown indication |
| 121698062 | 12169806 | 20 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 121698062 | 12169806 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 121698062 | 12169806 | Condition aggravated | |
| 121698062 | 12169806 | Postural orthostatic tachycardia syndrome | |
| 121698062 | 12169806 | Pre-existing condition improved | |
| 121698062 | 12169806 | Therapeutic response unexpected | |
| 121698062 | 12169806 | Weight increased |
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 |
|---|---|---|---|---|---|---|
| 121698062 | 12169806 | 1 | 201411 | 201411 | 0 | |
| 121698062 | 12169806 | 3 | 201506 | 0 | ||
| 121698062 | 12169806 | 4 | 201506 | 0 | ||
| 121698062 | 12169806 | 5 | 20131028 | 20150824 | 0 | |
| 121698062 | 12169806 | 6 | 20150824 | 0 | ||
| 121698062 | 12169806 | 7 | 20151001 | 0 | ||
| 121698062 | 12169806 | 8 | 20121028 | 20150101 | 0 | |
| 121698062 | 12169806 | 9 | 20101028 | 0 | ||
| 121698062 | 12169806 | 10 | 20101028 | 0 | ||
| 121698062 | 12169806 | 11 | 20131028 | 0 | ||
| 121698062 | 12169806 | 12 | 20110428 | 20150824 | 0 | |
| 121698062 | 12169806 | 13 | 20110428 | 0 | ||
| 121698062 | 12169806 | 14 | 20150821 | 20150823 | 0 | |
| 121698062 | 12169806 | 15 | 20150716 | 0 | ||
| 121698062 | 12169806 | 16 | 20141121 | 20141130 | 0 | |
| 121698062 | 12169806 | 17 | 20141031 | 0 | ||
| 121698062 | 12169806 | 18 | 20140628 | 20141101 | 0 | |
| 121698062 | 12169806 | 19 | 20140128 | 0 | ||
| 121698062 | 12169806 | 20 | 20121028 | 0 |