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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126511421 | 12651142 | 1 | I | 20160316 | 20160815 | 20160815 | PER | US-JAZZ-2016-US-005223 | JAZZ | 0.00 | F | Y | 66.67000 | KG | 20160815 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126511421 | 12651142 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | 21196 | 3 | G | ORAL SOLUTION | |||||||
| 126511421 | 12651142 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | 21196 | 4.5 | G | ORAL SOLUTION | |||||||
| 126511421 | 12651142 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | 21196 | 4.5 | G | ORAL SOLUTION | |||||||
| 126511421 | 12651142 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | 4.5 G, BID | 21196 | 4.5 | G | ORAL SOLUTION | ||||||||
| 126511421 | 12651142 | 5 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | 21196 | ORAL SOLUTION | |||||||||
| 126511421 | 12651142 | 6 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | 21196 | 2.25 | G | ORAL SOLUTION | |||||||
| 126511421 | 12651142 | 7 | SS | ARTHROTEC | DICLOFENAC SODIUMMISOPROSTOL | 1 | Y | 0 | |||||||||||
| 126511421 | 12651142 | 8 | C | LYRICA | PREGABALIN | 1 | U | 0 | |||||||||||
| 126511421 | 12651142 | 9 | C | ZYRTEC | CETIRIZINE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 126511421 | 12651142 | 10 | C | NASONEX | MOMETASONE FUROATE | 1 | U | 0 | |||||||||||
| 126511421 | 12651142 | 11 | C | ACYCLOVIR. | ACYCLOVIR | 1 | U | 0 | |||||||||||
| 126511421 | 12651142 | 12 | C | CRESTOR | ROSUVASTATIN CALCIUM | 1 | U | 0 | |||||||||||
| 126511421 | 12651142 | 13 | C | METFORMIN | METFORMIN HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 126511421 | 12651142 | 14 | C | CLONIDINE. | CLONIDINE | 1 | U | 0 | |||||||||||
| 126511421 | 12651142 | 15 | C | DEXTROAMPHETAMINE. | DEXTROAMPHETAMINE | 1 | U | 0 | |||||||||||
| 126511421 | 12651142 | 16 | C | CITALOPRAM | CITALOPRAM HYDROBROMIDE | 1 | U | 0 | |||||||||||
| 126511421 | 12651142 | 17 | C | TIZANIDINE. | TIZANIDINE | 1 | U | 0 | |||||||||||
| 126511421 | 12651142 | 18 | C | OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHENOXYCODONE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 126511421 | 12651142 | 19 | C | OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHENOXYCODONE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 126511421 | 12651142 | 20 | C | Pantoprazole | PANTOPRAZOLE SODIUM | 1 | U | 0 | |||||||||||
| 126511421 | 12651142 | 21 | C | DULOXETINE. | DULOXETINE | 1 | U | 0 | |||||||||||
| 126511421 | 12651142 | 22 | C | GIANVI | DROSPIRENONEETHINYL ESTRADIOL | 1 | U | 0 | |||||||||||
| 126511421 | 12651142 | 23 | C | Lysine | LYSINE | 1 | U | 0 | |||||||||||
| 126511421 | 12651142 | 24 | C | CRANBERRY. | CRANBERRY | 1 | U | 0 | TABLET | ||||||||||
| 126511421 | 12651142 | 25 | C | Multivitamin | VITAMINS | 1 | U | 0 | |||||||||||
| 126511421 | 12651142 | 26 | C | CYMBALTA | DULOXETINE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 126511421 | 12651142 | 27 | C | DEXEDRINE | DEXTROAMPHETAMINE SULFATE | 1 | U | 0 | |||||||||||
| 126511421 | 12651142 | 28 | C | PROTONIX | PANTOPRAZOLE SODIUM | 1 | U | 0 | |||||||||||
| 126511421 | 12651142 | 29 | C | ROZEREM | RAMELTEON | 1 | U | 0 | |||||||||||
| 126511421 | 12651142 | 30 | C | BESIVANCE | BESIFLOXACIN | 1 | U | 0 | |||||||||||
| 126511421 | 12651142 | 31 | C | PREDNISOLONE. | PREDNISOLONE | 1 | U | 0 | |||||||||||
| 126511421 | 12651142 | 32 | C | CLONAZEPAM. | CLONAZEPAM | 1 | U | 0 | |||||||||||
| 126511421 | 12651142 | 33 | C | FAMVIR | FAMCICLOVIR | 1 | U | 0 | |||||||||||
| 126511421 | 12651142 | 34 | C | PULMICORT TURBUHALER | BUDESONIDE | 1 | U | 0 | |||||||||||
| 126511421 | 12651142 | 35 | C | ALBUTEROL SULFATE. | ALBUTEROL SULFATE | 1 | U | 0 | |||||||||||
| 126511421 | 12651142 | 36 | C | CARISOPRODOL. | CARISOPRODOL | 1 | U | 0 | |||||||||||
| 126511421 | 12651142 | 37 | C | ENDOCET | ACETAMINOPHENOXYCODONE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 126511421 | 12651142 | 38 | C | FLONASE | FLUTICASONE PROPIONATE | 1 | U | 0 | |||||||||||
| 126511421 | 12651142 | 39 | C | LAMICTAL | LAMOTRIGINE | 1 | U | 0 | |||||||||||
| 126511421 | 12651142 | 40 | C | LEXAPRO | ESCITALOPRAM OXALATE | 1 | U | 0 | |||||||||||
| 126511421 | 12651142 | 41 | C | LIBRAX | CHLORDIAZEPOXIDE HYDROCHLORIDECLIDINIUM BROMIDE | 1 | U | 0 | |||||||||||
| 126511421 | 12651142 | 42 | C | LIPITOR | ATORVASTATIN CALCIUM | 1 | U | 0 | |||||||||||
| 126511421 | 12651142 | 43 | C | MACRODANTIN | NITROFURANTOIN | 1 | U | 0 | |||||||||||
| 126511421 | 12651142 | 44 | C | OPTIVAR | AZELASTINE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 126511421 | 12651142 | 45 | C | VALTREX | VALACYCLOVIR HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 126511421 | 12651142 | 46 | C | XYZAL | LEVOCETIRIZINE DIHYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 126511421 | 12651142 | 47 | C | YAZ | DROSPIRENONEETHINYL ESTRADIOL | 1 | U | 0 | |||||||||||
| 126511421 | 12651142 | 48 | C | Fish oil | FISH OIL | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126511421 | 12651142 | 1 | Somnolence |
| 126511421 | 12651142 | 2 | Narcolepsy |
| 126511421 | 12651142 | 7 | Product used for unknown indication |
| 126511421 | 12651142 | 8 | Psychomotor hyperactivity |
| 126511421 | 12651142 | 10 | Hypersensitivity |
| 126511421 | 12651142 | 11 | Oral herpes |
| 126511421 | 12651142 | 12 | Blood cholesterol increased |
| 126511421 | 12651142 | 13 | Glucose tolerance impaired |
| 126511421 | 12651142 | 14 | Hypertension |
| 126511421 | 12651142 | 15 | Narcolepsy |
| 126511421 | 12651142 | 16 | Depression |
| 126511421 | 12651142 | 17 | Intervertebral disc protrusion |
| 126511421 | 12651142 | 18 | Pain |
| 126511421 | 12651142 | 19 | Intervertebral disc protrusion |
| 126511421 | 12651142 | 20 | Gastrooesophageal reflux disease |
| 126511421 | 12651142 | 21 | Depression |
| 126511421 | 12651142 | 22 | Contraception |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126511421 | 12651142 | Abdominal pain upper | |
| 126511421 | 12651142 | Condition aggravated | |
| 126511421 | 12651142 | Eyelid ptosis |
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 |
|---|---|---|---|---|---|---|
| 126511421 | 12651142 | 1 | 200905 | 200905 | 0 | |
| 126511421 | 12651142 | 2 | 200905 | 201001 | 0 | |
| 126511421 | 12651142 | 3 | 201009 | 201012 | 0 | |
| 126511421 | 12651142 | 4 | 201108 | 201206 | 0 | |
| 126511421 | 12651142 | 6 | 201507 | 0 |