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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126006651 | 12600665 | 1 | I | 20160719 | 20160719 | 20160727 | 20160727 | EXP | US-JAZZ-2016-US-013615 | JAZZ | 59.73 | YR | F | Y | 0.00000 | 20160727 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126006651 | 12600665 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | U | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 126006651 | 12600665 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | U | 21196 | ORAL SOLUTION | ||||||||
| 126006651 | 12600665 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | U | 21196 | 4.5 | G | ORAL SOLUTION | ||||||
| 126006651 | 12600665 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | U | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 126006651 | 12600665 | 5 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | U | 21196 | ORAL SOLUTION | ||||||||
| 126006651 | 12600665 | 6 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | U | 21196 | 4.5 | G | ORAL SOLUTION | ||||||
| 126006651 | 12600665 | 7 | SS | EFFEXOR XR | VENLAFAXINE HYDROCHLORIDE | 1 | UNK | 0 | CAPSULE | ||||||||||
| 126006651 | 12600665 | 8 | C | RESTASIS | CYCLOSPORINE | 1 | UNK | U | 0 | ||||||||||
| 126006651 | 12600665 | 9 | C | SULFUR. | SULFUR | 1 | UNK | U | 0 | POWDER | |||||||||
| 126006651 | 12600665 | 10 | C | PREDNISONE. | PREDNISONE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126006651 | 12600665 | 11 | C | PROAIR HFA | ALBUTEROL SULFATE | 1 | UNK | U | 0 | POWDER | |||||||||
| 126006651 | 12600665 | 12 | C | XOPENEX | LEVALBUTEROL HYDROCHLORIDE | 1 | UNK | U | 0 | SOLUTION | |||||||||
| 126006651 | 12600665 | 13 | C | PREMARIN | ESTROGENS, CONJUGATED | 1 | Vaginal | UNK | U | 0 | CREAM | ||||||||
| 126006651 | 12600665 | 14 | C | GABAPENTIN. | GABAPENTIN | 1 | 300 MG | U | 0 | 300 | MG | CAPSULE | |||||||
| 126006651 | 12600665 | 15 | C | GABAPENTIN. | GABAPENTIN | 1 | 100 MG | U | 0 | 100 | MG | CAPSULE | |||||||
| 126006651 | 12600665 | 16 | C | TUDORZA PRESSAIR | ACLIDINIUM BROMIDE | 1 | UNK | U | 0 | INHALER | |||||||||
| 126006651 | 12600665 | 17 | C | TUDORZA PRESSAIR | ACLIDINIUM BROMIDE | 1 | UNK | U | 0 | INHALER | |||||||||
| 126006651 | 12600665 | 18 | C | RITALIN | METHYLPHENIDATE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126006651 | 12600665 | 19 | C | AMOXICILLIN. | AMOXICILLIN | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 126006651 | 12600665 | 20 | C | ADDERALL | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126006651 | 12600665 | 21 | C | Calcium + vitamin d | CALCIUMVITAMIN D | 1 | UNK | U | 0 | TABLET | |||||||||
| 126006651 | 12600665 | 22 | C | Fish oil | FISH OIL | 1 | UNK | U | 0 | ||||||||||
| 126006651 | 12600665 | 23 | C | ALBUTEROL SULFATE. | ALBUTEROL SULFATE | 1 | UNK | U | 0 | SOLUTION | |||||||||
| 126006651 | 12600665 | 24 | C | AMLODIPINE BESYLATE. | AMLODIPINE BESYLATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126006651 | 12600665 | 25 | C | ASPIRIN. | ASPIRIN | 1 | UNK | U | 0 | CHEWABLE TABLET | |||||||||
| 126006651 | 12600665 | 26 | C | PROAIR HFA | ALBUTEROL SULFATE | 1 | UNK | U | 0 | INHALER | |||||||||
| 126006651 | 12600665 | 27 | C | DULERA | FORMOTEROL FUMARATE DIHYDRATEMOMETASONE FUROATE | 1 | UNK | U | 0 | INHALER | |||||||||
| 126006651 | 12600665 | 28 | C | KEPPRA | LEVETIRACETAM | 1 | UNK | U | 0 | TABLET | |||||||||
| 126006651 | 12600665 | 29 | C | NUVIGIL | ARMODAFINIL | 1 | UNK | U | 0 | TABLET | |||||||||
| 126006651 | 12600665 | 30 | C | ADDERALL XR | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 126006651 | 12600665 | 31 | C | ADDERALL XR | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 126006651 | 12600665 | 32 | C | INDOMETHACIN. | INDOMETHACIN | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 126006651 | 12600665 | 33 | C | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 126006651 | 12600665 | 34 | C | ALLEGRA ALLERGY | FEXOFENADINE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126006651 | 12600665 | 35 | C | NASACORT ALLERGY 24HR | TRIAMCINOLONE ACETONIDE | 1 | UNK | U | 0 | SPRAY | |||||||||
| 126006651 | 12600665 | 36 | C | PRILOSEC | OMEPRAZOLE MAGNESIUM | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 126006651 | 12600665 | 37 | C | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | UNK | U | 0 | INHALER | |||||||||
| 126006651 | 12600665 | 38 | C | TOPROL XL | METOPROLOL SUCCINATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126006651 | 12600665 | 39 | C | ZANTAC | RANITIDINE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126006651 | 12600665 | 40 | C | SPIRIVA | TIOTROPIUM BROMIDE MONOHYDRATE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 126006651 | 12600665 | 41 | C | Nortriptyline hcl | NORTRIPTYLINE HYDROCHLORIDE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 126006651 | 12600665 | 42 | C | BENICAR | OLMESARTAN MEDOXOMIL | 1 | UNK | U | 0 | TABLET | |||||||||
| 126006651 | 12600665 | 43 | C | FEXOFENADINE HCL | FEXOFENADINE HYDROCHLORIDE | 1 | U | 0 | TABLET | ||||||||||
| 126006651 | 12600665 | 44 | C | FINACEA | AZELAIC ACID | 1 | UNK | U | 0 | GEL | |||||||||
| 126006651 | 12600665 | 45 | C | PATANASE | OLOPATADINE HYDROCHLORIDE | 1 | UNK | U | 0 | NASAL SPRAY | |||||||||
| 126006651 | 12600665 | 46 | C | VERAMYST | FLUTICASONE FUROATE | 1 | UNK | U | 0 | NASAL SPRAY |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126006651 | 12600665 | 1 | Narcolepsy |
| 126006651 | 12600665 | 7 | Product used for unknown indication |
| 126006651 | 12600665 | 8 | Product used for unknown indication |
| 126006651 | 12600665 | 9 | Product used for unknown indication |
| 126006651 | 12600665 | 10 | Product used for unknown indication |
| 126006651 | 12600665 | 11 | Product used for unknown indication |
| 126006651 | 12600665 | 12 | Product used for unknown indication |
| 126006651 | 12600665 | 13 | Product used for unknown indication |
| 126006651 | 12600665 | 14 | Product used for unknown indication |
| 126006651 | 12600665 | 16 | Product used for unknown indication |
| 126006651 | 12600665 | 18 | Product used for unknown indication |
| 126006651 | 12600665 | 19 | Product used for unknown indication |
| 126006651 | 12600665 | 20 | Product used for unknown indication |
| 126006651 | 12600665 | 21 | Product used for unknown indication |
| 126006651 | 12600665 | 22 | Product used for unknown indication |
| 126006651 | 12600665 | 23 | Product used for unknown indication |
| 126006651 | 12600665 | 24 | Product used for unknown indication |
| 126006651 | 12600665 | 25 | Product used for unknown indication |
| 126006651 | 12600665 | 26 | Product used for unknown indication |
| 126006651 | 12600665 | 27 | Product used for unknown indication |
| 126006651 | 12600665 | 28 | Product used for unknown indication |
| 126006651 | 12600665 | 29 | Product used for unknown indication |
| 126006651 | 12600665 | 30 | Product used for unknown indication |
| 126006651 | 12600665 | 32 | Product used for unknown indication |
| 126006651 | 12600665 | 33 | Product used for unknown indication |
| 126006651 | 12600665 | 34 | Product used for unknown indication |
| 126006651 | 12600665 | 35 | Product used for unknown indication |
| 126006651 | 12600665 | 36 | Product used for unknown indication |
| 126006651 | 12600665 | 37 | Product used for unknown indication |
| 126006651 | 12600665 | 38 | Product used for unknown indication |
| 126006651 | 12600665 | 39 | Product used for unknown indication |
| 126006651 | 12600665 | 40 | Product used for unknown indication |
| 126006651 | 12600665 | 41 | Product used for unknown indication |
| 126006651 | 12600665 | 42 | Product used for unknown indication |
| 126006651 | 12600665 | 43 | Product used for unknown indication |
| 126006651 | 12600665 | 44 | Product used for unknown indication |
| 126006651 | 12600665 | 45 | Product used for unknown indication |
| 126006651 | 12600665 | 46 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126006651 | 12600665 | DS |
| 126006651 | 12600665 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126006651 | 12600665 | Bone graft | |
| 126006651 | 12600665 | Disability | |
| 126006651 | 12600665 | Gastrooesophageal reflux disease | |
| 126006651 | 12600665 | Pre-existing condition improved | |
| 126006651 | 12600665 | Tooth extraction | |
| 126006651 | 12600665 | Unevaluable event |
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 |
|---|---|---|---|---|---|---|
| 126006651 | 12600665 | 1 | 201106 | 201106 | 0 | |
| 126006651 | 12600665 | 2 | 201106 | 201110 | 0 | |
| 126006651 | 12600665 | 3 | 201110 | 2012 | 0 | |
| 126006651 | 12600665 | 4 | 201405 | 201407 | 0 | |
| 126006651 | 12600665 | 5 | 201407 | 201510 | 0 | |
| 126006651 | 12600665 | 6 | 201510 | 0 | ||
| 126006651 | 12600665 | 7 | 20140522 | 201506 | 0 | |
| 126006651 | 12600665 | 8 | 201606 | 0 | ||
| 126006651 | 12600665 | 9 | 201606 | 0 | ||
| 126006651 | 12600665 | 10 | 201605 | 201605 | 0 | |
| 126006651 | 12600665 | 11 | 201605 | 0 | ||
| 126006651 | 12600665 | 12 | 201605 | 0 | ||
| 126006651 | 12600665 | 13 | 201604 | 0 | ||
| 126006651 | 12600665 | 14 | 20140522 | 20151001 | 0 | |
| 126006651 | 12600665 | 15 | 20151125 | 201605 | 0 | |
| 126006651 | 12600665 | 16 | 20140522 | 20151001 | 0 | |
| 126006651 | 12600665 | 17 | 20151124 | 0 | ||
| 126006651 | 12600665 | 18 | 20150929 | 201605 | 0 | |
| 126006651 | 12600665 | 19 | 20151021 | 20151124 | 0 | |
| 126006651 | 12600665 | 20 | 20151013 | 20151027 | 0 | |
| 126006651 | 12600665 | 21 | 20151001 | 0 | ||
| 126006651 | 12600665 | 22 | 20151001 | 0 | ||
| 126006651 | 12600665 | 23 | 20150929 | 201605 | 0 | |
| 126006651 | 12600665 | 24 | 20150929 | 0 | ||
| 126006651 | 12600665 | 25 | 20150929 | 0 | ||
| 126006651 | 12600665 | 26 | 20150929 | 201512 | 0 | |
| 126006651 | 12600665 | 27 | 20150730 | 0 | ||
| 126006651 | 12600665 | 28 | 20141219 | 201601 | 0 | |
| 126006651 | 12600665 | 29 | 20141219 | 20151001 | 0 | |
| 126006651 | 12600665 | 30 | 20140522 | 0 | ||
| 126006651 | 12600665 | 31 | 20140926 | 20150202 | 0 | |
| 126006651 | 12600665 | 32 | 20140619 | 20151001 | 0 | |
| 126006651 | 12600665 | 33 | 20140619 | 20151001 | 0 | |
| 126006651 | 12600665 | 34 | 20140522 | 20151001 | 0 | |
| 126006651 | 12600665 | 35 | 20140522 | 0 | ||
| 126006651 | 12600665 | 36 | 20140522 | 20151001 | 0 | |
| 126006651 | 12600665 | 37 | 20140522 | 20150730 | 0 | |
| 126006651 | 12600665 | 38 | 20140522 | 0 | ||
| 126006651 | 12600665 | 39 | 20140522 | 20151001 | 0 | |
| 126006651 | 12600665 | 40 | 20121121 | 20140522 | 0 | |
| 126006651 | 12600665 | 41 | 20121023 | 20140522 | 0 | |
| 126006651 | 12600665 | 42 | 20140522 | 0 | ||
| 126006651 | 12600665 | 44 | 20140522 | 0 | ||
| 126006651 | 12600665 | 45 | 20140522 | 0 | ||
| 126006651 | 12600665 | 46 | 20140522 | 0 |