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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121735166 | 12173516 | 6 | F | 201601 | 20160713 | 20160311 | 20160721 | EXP | US-JAZZ-2016-US-000439 | JAZZ | 49.36 | YR | F | Y | 0.00000 | 20160721 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121735166 | 12173516 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | Y | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 121735166 | 12173516 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | Y | 21196 | ORAL SOLUTION | ||||||||
| 121735166 | 12173516 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | Y | 21196 | 4.5 | G | ORAL SOLUTION | ||||||
| 121735166 | 12173516 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | Y | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 121735166 | 12173516 | 5 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | Y | 21196 | ORAL SOLUTION | ||||||||
| 121735166 | 12173516 | 6 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | HALFWAY BETWEEN 3 G AND 3.75 G | Y | 21196 | ORAL SOLUTION | ||||||||
| 121735166 | 12173516 | 7 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | Y | 21196 | 4.5 | G | ORAL SOLUTION | ||||||
| 121735166 | 12173516 | 8 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | UNKNOWN DOSE | Y | 21196 | ORAL SOLUTION | ||||||||
| 121735166 | 12173516 | 9 | SS | CLONAZEPAM. | CLONAZEPAM | 1 | 2 MG, BID | U | 0 | 2 | MG | TABLET | |||||||
| 121735166 | 12173516 | 10 | SS | CLONAZEPAM. | CLONAZEPAM | 1 | UNK | U | 0 | TABLET | |||||||||
| 121735166 | 12173516 | 11 | C | GABAPENTIN. | GABAPENTIN | 1 | 600 MG, BID | U | 0 | 600 | MG | TABLET | |||||||
| 121735166 | 12173516 | 12 | C | GABAPENTIN. | GABAPENTIN | 1 | UNK | U | 0 | TABLET | |||||||||
| 121735166 | 12173516 | 13 | C | ADDERALL | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | UNK | U | 0 | ||||||||||
| 121735166 | 12173516 | 14 | C | Naltrexone hcl | NALTREXONE HYDROCHLORIDE | 1 | UNK | U | 0 | ||||||||||
| 121735166 | 12173516 | 15 | C | CRESTOR | ROSUVASTATIN CALCIUM | 1 | UNK | U | 0 | TABLET | |||||||||
| 121735166 | 12173516 | 16 | C | LIOTHYRONINE SODIUM. | LIOTHYRONINE SODIUM | 1 | UNK | U | 0 | TABLET | |||||||||
| 121735166 | 12173516 | 17 | C | Magnesium | MAGNESIUM | 1 | UNK | U | 0 | POWDER | |||||||||
| 121735166 | 12173516 | 18 | C | PROAIR HFA | ALBUTEROL SULFATE | 1 | 90 ?G, BID | U | 0 | 90 | UG | INHALER | |||||||
| 121735166 | 12173516 | 19 | C | Dhea | PRASTERONE | 1 | UNK | U | 0 | ||||||||||
| 121735166 | 12173516 | 20 | C | VENLAFAXINE | VENLAFAXINE HYDROCHLORIDE | 1 | 150 MG IN THE MORNING AND 75 MG AT NIGHT | U | 0 | CAPSULE | |||||||||
| 121735166 | 12173516 | 21 | C | CYCLAFEM 7/7/7 | ETHINYL ESTRADIOLNORETHINDRONE | 1 | UNK | U | 0 | TABLET | |||||||||
| 121735166 | 12173516 | 22 | C | Melatonin | MELATONIN | 1 | UNK | U | 0 | TABLET | |||||||||
| 121735166 | 12173516 | 23 | C | CELEBREX | CELECOXIB | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 121735166 | 12173516 | 24 | C | Valacyclovir hcl | VALACYCLOVIR HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 121735166 | 12173516 | 25 | C | Amphetamine salts | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 121735166 | 12173516 | 26 | C | ACETAMINOPHENHYDROCODONE BITARTRATE | ACETAMINOPHENHYDROCODONE BITARTRATE | 1 | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 121735166 | 12173516 | 1 | Narcolepsy |
| 121735166 | 12173516 | 2 | Cataplexy |
| 121735166 | 12173516 | 9 | Sleep disorder |
| 121735166 | 12173516 | 11 | Fibromyalgia |
| 121735166 | 12173516 | 13 | Narcolepsy |
| 121735166 | 12173516 | 14 | Fibromyalgia |
| 121735166 | 12173516 | 15 | Blood cholesterol increased |
| 121735166 | 12173516 | 16 | Hypothyroidism |
| 121735166 | 12173516 | 17 | Supplementation therapy |
| 121735166 | 12173516 | 18 | Asthma |
| 121735166 | 12173516 | 19 | Blood testosterone abnormal |
| 121735166 | 12173516 | 20 | Depression |
| 121735166 | 12173516 | 21 | Product used for unknown indication |
| 121735166 | 12173516 | 22 | Product used for unknown indication |
| 121735166 | 12173516 | 23 | Product used for unknown indication |
| 121735166 | 12173516 | 24 | Product used for unknown indication |
| 121735166 | 12173516 | 25 | Product used for unknown indication |
| 121735166 | 12173516 | 26 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 121735166 | 12173516 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 121735166 | 12173516 | Agitation | |
| 121735166 | 12173516 | Anxiety | |
| 121735166 | 12173516 | Asthma | |
| 121735166 | 12173516 | Cardiac stress test abnormal | |
| 121735166 | 12173516 | Chest discomfort | |
| 121735166 | 12173516 | Chest pain | |
| 121735166 | 12173516 | Drug ineffective | |
| 121735166 | 12173516 | Dysphonia | |
| 121735166 | 12173516 | Dyspnoea | |
| 121735166 | 12173516 | Fatigue | |
| 121735166 | 12173516 | Fear | |
| 121735166 | 12173516 | Heart rate increased | |
| 121735166 | 12173516 | Hyperhidrosis | |
| 121735166 | 12173516 | Hypertension | |
| 121735166 | 12173516 | Intentional product misuse | |
| 121735166 | 12173516 | Irritability | |
| 121735166 | 12173516 | Nausea | |
| 121735166 | 12173516 | Palpitations | |
| 121735166 | 12173516 | Pre-existing condition improved | |
| 121735166 | 12173516 | 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 |
|---|---|---|---|---|---|---|
| 121735166 | 12173516 | 1 | 201509 | 201509 | 0 | |
| 121735166 | 12173516 | 2 | 201509 | 201510 | 0 | |
| 121735166 | 12173516 | 3 | 201510 | 2015 | 0 | |
| 121735166 | 12173516 | 4 | 20160105 | 2016 | 0 | |
| 121735166 | 12173516 | 5 | 2016 | 2016 | 0 | |
| 121735166 | 12173516 | 6 | 2016 | 2016 | 0 | |
| 121735166 | 12173516 | 7 | 2016 | 2016 | 0 | |
| 121735166 | 12173516 | 8 | 2016 | 0 | ||
| 121735166 | 12173516 | 9 | 20150731 | 2015 | 0 | |
| 121735166 | 12173516 | 10 | 20160105 | 0 | ||
| 121735166 | 12173516 | 11 | 20150301 | 2015 | 0 | |
| 121735166 | 12173516 | 12 | 20160105 | 0 | ||
| 121735166 | 12173516 | 14 | 20140731 | 0 | ||
| 121735166 | 12173516 | 15 | 20110701 | 0 | ||
| 121735166 | 12173516 | 16 | 20130701 | 0 | ||
| 121735166 | 12173516 | 17 | 20150101 | 0 | ||
| 121735166 | 12173516 | 18 | 20150826 | 0 | ||
| 121735166 | 12173516 | 20 | 20140101 | 20150826 | 0 | |
| 121735166 | 12173516 | 22 | 20150917 | 0 | ||
| 121735166 | 12173516 | 23 | 20150731 | 0 | ||
| 121735166 | 12173516 | 24 | 20150731 | 0 | ||
| 121735166 | 12173516 | 25 | 20080701 | 0 | ||
| 121735166 | 12173516 | 26 | 20080701 | 0 |