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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127062152 | 12706215 | 2 | F | 201604 | 20160510 | 20160901 | 20160901 | PER | US-JAZZ-2016-US-007921 | JAZZ | 34.52 | YR | F | Y | 0.00000 | 20160901 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127062152 | 12706215 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | Y | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 127062152 | 12706215 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | Y | 21196 | ORAL SOLUTION | ||||||||
| 127062152 | 12706215 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | Y | 21196 | 4.5 | G | ORAL SOLUTION | ||||||
| 127062152 | 12706215 | 4 | SS | PERCOCET | ACETAMINOPHENOXYCODONE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 127062152 | 12706215 | 5 | C | VISTARIL | HYDROXYZINE PAMOATE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 127062152 | 12706215 | 6 | C | FLAGYL | METRONIDAZOLEMETRONIDAZOLE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 127062152 | 12706215 | 7 | C | BENADRYL ALLERGY | DIPHENHYDRAMINE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 127062152 | 12706215 | 8 | C | Gralise er | 2 | UNK | U | 0 | TABLET | ||||||||||
| 127062152 | 12706215 | 9 | C | CIPRO | CIPROFLOXACIN HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 127062152 | 12706215 | 10 | C | ATROVENT | IPRATROPIUM BROMIDE | 1 | UNK | U | 0 | SPRAY | |||||||||
| 127062152 | 12706215 | 11 | C | Benztropine mesilate | BENZTROPINE MESYLATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 127062152 | 12706215 | 12 | C | CELEXA | CITALOPRAM HYDROBROMIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 127062152 | 12706215 | 13 | C | DICYCLOMINE | DICYCLOMINE HYDROCHLORIDE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 127062152 | 12706215 | 14 | C | GABAPENTIN. | GABAPENTIN | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 127062152 | 12706215 | 15 | C | IBUPROFEN IB | IBUPROFEN | 1 | UNK | U | 0 | ||||||||||
| 127062152 | 12706215 | 16 | C | LYRICA | PREGABALIN | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 127062152 | 12706215 | 17 | C | PROAIR HFA | ALBUTEROL SULFATE | 1 | UNK | U | 0 | INHALER | |||||||||
| 127062152 | 12706215 | 18 | C | PROVIGIL | MODAFINIL | 1 | UNK | U | 0 | TABLET | |||||||||
| 127062152 | 12706215 | 19 | C | PULMICORT TURBUHALER | BUDESONIDE | 1 | UNK | U | 0 | ||||||||||
| 127062152 | 12706215 | 20 | C | SEROQUEL | QUETIAPINE FUMARATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 127062152 | 12706215 | 21 | C | VALTREX | VALACYCLOVIR HYDROCHLORIDE | 1 | UNK | U | 0 | ||||||||||
| 127062152 | 12706215 | 22 | C | ALBUTEROL SULFATE. | ALBUTEROL SULFATE | 1 | U | 0 | SOLUTION | ||||||||||
| 127062152 | 12706215 | 23 | C | AMITIZA | LUBIPROSTONE | 1 | U | 0 | CAPSULE | ||||||||||
| 127062152 | 12706215 | 24 | C | Aspirin e.c | ASPIRIN | 1 | U | 0 | TABLET | ||||||||||
| 127062152 | 12706215 | 25 | C | BREO ELLIPTA | FLUTICASONE FUROATEVILANTEROL TRIFENATATE | 1 | U | 0 | INHALER | ||||||||||
| 127062152 | 12706215 | 26 | C | CLONAZEPAM. | CLONAZEPAM | 1 | UNK | U | 0 | TABLET | |||||||||
| 127062152 | 12706215 | 27 | C | DULOXETINE HYDROCHLORIDE. | DULOXETINE HYDROCHLORIDE | 1 | U | 0 | CAPSULE | ||||||||||
| 127062152 | 12706215 | 28 | C | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | UNK | U | 0 | ||||||||||
| 127062152 | 12706215 | 29 | C | MIRALAX | POLYETHYLENE GLYCOL 3350 | 1 | U | 0 | POWDER | ||||||||||
| 127062152 | 12706215 | 30 | C | Protonix dr | 2 | U | 0 | TABLET | |||||||||||
| 127062152 | 12706215 | 31 | C | QVAR | BECLOMETHASONE DIPROPIONATE | 1 | Oral | UNK | U | 0 | INHALER | ||||||||
| 127062152 | 12706215 | 32 | C | Sarna | 2 | U | 0 | LOTION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127062152 | 12706215 | 1 | Narcolepsy |
| 127062152 | 12706215 | 4 | Product used for unknown indication |
| 127062152 | 12706215 | 5 | Product used for unknown indication |
| 127062152 | 12706215 | 6 | Product used for unknown indication |
| 127062152 | 12706215 | 7 | Product used for unknown indication |
| 127062152 | 12706215 | 8 | Product used for unknown indication |
| 127062152 | 12706215 | 9 | Product used for unknown indication |
| 127062152 | 12706215 | 10 | Product used for unknown indication |
| 127062152 | 12706215 | 11 | Product used for unknown indication |
| 127062152 | 12706215 | 12 | Product used for unknown indication |
| 127062152 | 12706215 | 13 | Product used for unknown indication |
| 127062152 | 12706215 | 14 | Product used for unknown indication |
| 127062152 | 12706215 | 15 | Product used for unknown indication |
| 127062152 | 12706215 | 16 | Product used for unknown indication |
| 127062152 | 12706215 | 17 | Product used for unknown indication |
| 127062152 | 12706215 | 18 | Product used for unknown indication |
| 127062152 | 12706215 | 19 | Product used for unknown indication |
| 127062152 | 12706215 | 20 | Product used for unknown indication |
| 127062152 | 12706215 | 21 | Product used for unknown indication |
| 127062152 | 12706215 | 22 | Product used for unknown indication |
| 127062152 | 12706215 | 23 | Product used for unknown indication |
| 127062152 | 12706215 | 24 | Product used for unknown indication |
| 127062152 | 12706215 | 25 | Product used for unknown indication |
| 127062152 | 12706215 | 26 | Product used for unknown indication |
| 127062152 | 12706215 | 27 | Product used for unknown indication |
| 127062152 | 12706215 | 28 | Product used for unknown indication |
| 127062152 | 12706215 | 29 | Product used for unknown indication |
| 127062152 | 12706215 | 30 | Product used for unknown indication |
| 127062152 | 12706215 | 31 | Product used for unknown indication |
| 127062152 | 12706215 | 32 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127062152 | 12706215 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127062152 | 12706215 | Back pain | |
| 127062152 | 12706215 | Decreased appetite | |
| 127062152 | 12706215 | Depression | |
| 127062152 | 12706215 | Initial insomnia | |
| 127062152 | 12706215 | Musculoskeletal pain | |
| 127062152 | 12706215 | Nausea | |
| 127062152 | 12706215 | Oedema peripheral | |
| 127062152 | 12706215 | Oropharyngeal pain | |
| 127062152 | 12706215 | Panic attack | |
| 127062152 | 12706215 | Rash | |
| 127062152 | 12706215 | Rhinorrhoea | |
| 127062152 | 12706215 | Vascular pain | |
| 127062152 | 12706215 | Wrong technique in product usage process |
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 |
|---|---|---|---|---|---|---|
| 127062152 | 12706215 | 1 | 201601 | 201601 | 0 | |
| 127062152 | 12706215 | 3 | 2016 | 201604 | 0 | |
| 127062152 | 12706215 | 4 | 20160419 | 201604 | 0 | |
| 127062152 | 12706215 | 5 | 201604 | 0 | ||
| 127062152 | 12706215 | 6 | 201603 | 201604 | 0 | |
| 127062152 | 12706215 | 7 | 201602 | 201602 | 0 | |
| 127062152 | 12706215 | 8 | 201602 | 201604 | 0 | |
| 127062152 | 12706215 | 9 | 201601 | 201602 | 0 | |
| 127062152 | 12706215 | 10 | 20160105 | 0 | ||
| 127062152 | 12706215 | 11 | 20160105 | 20160122 | 0 | |
| 127062152 | 12706215 | 12 | 20160105 | 201604 | 0 | |
| 127062152 | 12706215 | 13 | 20160105 | 20160122 | 0 | |
| 127062152 | 12706215 | 14 | 20160105 | 201604 | 0 | |
| 127062152 | 12706215 | 15 | 20160105 | 0 | ||
| 127062152 | 12706215 | 16 | 20160105 | 20160122 | 0 | |
| 127062152 | 12706215 | 17 | 20160105 | 201604 | 0 | |
| 127062152 | 12706215 | 18 | 20160105 | 0 | ||
| 127062152 | 12706215 | 19 | 20160105 | 0 | ||
| 127062152 | 12706215 | 20 | 20160105 | 201602 | 0 | |
| 127062152 | 12706215 | 21 | 20160105 | 201604 | 0 | |
| 127062152 | 12706215 | 26 | 201604 | 0 | ||
| 127062152 | 12706215 | 28 | 201604 | 0 | ||
| 127062152 | 12706215 | 31 | 201604 | 0 |