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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116141383 | 11614138 | 3 | F | 201211 | 20160719 | 20151008 | 20160727 | EXP | US-JAZZ-JPI-P-028801 | JAZZ | 56.02 | YR | F | Y | 68.00000 | KG | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116141383 | 11614138 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | Y | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 116141383 | 11614138 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | UNK UNKNOWN, UNK | Y | 21196 | ORAL SOLUTION | ||||||||
| 116141383 | 11614138 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | Y | 21196 | 4.5 | G | ORAL SOLUTION | ||||||
| 116141383 | 11614138 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.25 G, BID | Y | 3103821 | 21196 | 4.25 | G | ORAL SOLUTION | |||||
| 116141383 | 11614138 | 5 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | UNK | Y | 21196 | ORAL SOLUTION | ||||||||
| 116141383 | 11614138 | 6 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4 G, BID | Y | 21196 | 4 | G | ORAL SOLUTION | ||||||
| 116141383 | 11614138 | 7 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | Y | 21196 | 4.5 | G | ORAL SOLUTION | ||||||
| 116141383 | 11614138 | 8 | C | Amphetamine mixed salts | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | U | 0 | |||||||||||
| 116141383 | 11614138 | 9 | C | Nortriptyline | NORTRIPTYLINE | 1 | U | 0 | |||||||||||
| 116141383 | 11614138 | 10 | C | OLMESARTAN MEDOXOMIL. | OLMESARTAN MEDOXOMIL | 1 | U | 0 | |||||||||||
| 116141383 | 11614138 | 11 | C | METOPROLOL. | METOPROLOL | 1 | U | 0 | 100 | MG | |||||||||
| 116141383 | 11614138 | 12 | C | Budesonide w/formoterol fumarate | BUDESONIDEFORMOTEROL FUMARATE | 1 | U | 0 | |||||||||||
| 116141383 | 11614138 | 13 | C | ASPIRIN. | ASPIRIN | 1 | U | 0 | 81 | MG | |||||||||
| 116141383 | 11614138 | 14 | C | ASPIRIN. | ASPIRIN | 1 | U | 0 | |||||||||||
| 116141383 | 11614138 | 15 | C | ASPIRIN. | ASPIRIN | 1 | U | 0 | |||||||||||
| 116141383 | 11614138 | 16 | C | Calcium +D | CALCIUMVITAMIN D | 1 | UNK | U | 0 | ||||||||||
| 116141383 | 11614138 | 17 | C | Fish oil | FISH OIL | 1 | UNK | U | 0 | ||||||||||
| 116141383 | 11614138 | 18 | C | ALBUTEROL SULFATE. | ALBUTEROL SULFATE | 1 | UNK, PRN | U | 0 | ||||||||||
| 116141383 | 11614138 | 19 | C | AMLODIPINE | AMLODIPINE BESYLATE | 1 | UNK, QD | U | 0 | ||||||||||
| 116141383 | 11614138 | 20 | C | Proair Inhaler | 2 | UNK | U | 0 | INHALER | ||||||||||
| 116141383 | 11614138 | 21 | C | RITALIN LA | METHYLPHENIDATE HYDROCHLORIDE | 1 | UNK | U | 0 | ||||||||||
| 116141383 | 11614138 | 22 | C | DULERA | FORMOTEROL FUMARATE DIHYDRATEMOMETASONE FUROATE | 1 | 100/5 UG | U | 0 | INHALER | |||||||||
| 116141383 | 11614138 | 23 | C | INDOMETHACIN. | INDOMETHACIN | 1 | UNK, PRN | U | 0 | ||||||||||
| 116141383 | 11614138 | 24 | C | ALLEGRA | FEXOFENADINE HYDROCHLORIDE | 1 | UNK UNK, QD | U | 0 | ||||||||||
| 116141383 | 11614138 | 25 | C | EFFEXOR XR | VENLAFAXINE HYDROCHLORIDE | 1 | UNK, TID | U | 0 | ||||||||||
| 116141383 | 11614138 | 26 | C | EFFEXOR XR | VENLAFAXINE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 116141383 | 11614138 | 27 | C | NASACORT | TRIAMCINOLONE ACETONIDE | 1 | UNK | U | 0 | SPRAY | |||||||||
| 116141383 | 11614138 | 28 | C | TOPROL XL | METOPROLOL SUCCINATE | 1 | Oral | UNK, QD | U | 0 | |||||||||
| 116141383 | 11614138 | 29 | C | TUDORZA PRESSAIR | ACLIDINIUM BROMIDE | 1 | U | 0 | |||||||||||
| 116141383 | 11614138 | 30 | C | PRILOSEC | OMEPRAZOLE MAGNESIUM | 1 | U | 0 | |||||||||||
| 116141383 | 11614138 | 31 | C | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | U | 0 | |||||||||||
| 116141383 | 11614138 | 32 | C | GABAPENTIN. | GABAPENTIN | 1 | U | 0 | |||||||||||
| 116141383 | 11614138 | 33 | C | ZANTAC | RANITIDINE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 116141383 | 11614138 | 34 | C | SPIRIVA | TIOTROPIUM BROMIDE MONOHYDRATE | 1 | U | 0 | |||||||||||
| 116141383 | 11614138 | 35 | C | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | U | 0 | |||||||||||
| 116141383 | 11614138 | 36 | C | Nortriptyline hcl | NORTRIPTYLINE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 116141383 | 11614138 | 37 | C | ADDERALL | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | U | 0 | |||||||||||
| 116141383 | 11614138 | 38 | C | BENICAR | OLMESARTAN MEDOXOMIL | 1 | U | 0 | |||||||||||
| 116141383 | 11614138 | 39 | C | FINACEA | AZELAIC ACID | 1 | U | 0 | |||||||||||
| 116141383 | 11614138 | 40 | C | PATANASE | OLOPATADINE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 116141383 | 11614138 | 41 | C | VERAMYST | FLUTICASONE FUROATE | 1 | U | 0 | |||||||||||
| 116141383 | 11614138 | 42 | C | NUVIGIL | ARMODAFINIL | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 116141383 | 11614138 | 1 | Narcolepsy |
| 116141383 | 11614138 | 2 | Cataplexy |
| 116141383 | 11614138 | 8 | Narcolepsy |
| 116141383 | 11614138 | 9 | Migraine |
| 116141383 | 11614138 | 10 | Hypertension |
| 116141383 | 11614138 | 11 | Hypertension |
| 116141383 | 11614138 | 12 | Chronic obstructive pulmonary disease |
| 116141383 | 11614138 | 13 | Cardiovascular event prophylaxis |
| 116141383 | 11614138 | 14 | Bundle branch block right |
| 116141383 | 11614138 | 15 | Heart rate irregular |
| 116141383 | 11614138 | 16 | Supplementation therapy |
| 116141383 | 11614138 | 17 | Dry eye |
| 116141383 | 11614138 | 18 | Asthma |
| 116141383 | 11614138 | 19 | Hypertension |
| 116141383 | 11614138 | 20 | Asthma |
| 116141383 | 11614138 | 21 | Narcolepsy |
| 116141383 | 11614138 | 22 | Asthma |
| 116141383 | 11614138 | 23 | Headache |
| 116141383 | 11614138 | 24 | Hypersensitivity |
| 116141383 | 11614138 | 25 | Anxiety |
| 116141383 | 11614138 | 26 | Abnormal dreams |
| 116141383 | 11614138 | 27 | Product used for unknown indication |
| 116141383 | 11614138 | 28 | Heart rate irregular |
| 116141383 | 11614138 | 29 | Product used for unknown indication |
| 116141383 | 11614138 | 30 | Product used for unknown indication |
| 116141383 | 11614138 | 31 | Product used for unknown indication |
| 116141383 | 11614138 | 32 | Product used for unknown indication |
| 116141383 | 11614138 | 33 | Product used for unknown indication |
| 116141383 | 11614138 | 34 | Product used for unknown indication |
| 116141383 | 11614138 | 35 | Product used for unknown indication |
| 116141383 | 11614138 | 36 | Product used for unknown indication |
| 116141383 | 11614138 | 37 | Product used for unknown indication |
| 116141383 | 11614138 | 38 | Product used for unknown indication |
| 116141383 | 11614138 | 39 | Product used for unknown indication |
| 116141383 | 11614138 | 40 | Product used for unknown indication |
| 116141383 | 11614138 | 41 | Product used for unknown indication |
| 116141383 | 11614138 | 42 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 116141383 | 11614138 | HO |
| 116141383 | 11614138 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 116141383 | 11614138 | Anxiety | |
| 116141383 | 11614138 | Aphasia | |
| 116141383 | 11614138 | Dizziness | |
| 116141383 | 11614138 | Dyspnoea | |
| 116141383 | 11614138 | Hallucinations, mixed | |
| 116141383 | 11614138 | Incoherent | |
| 116141383 | 11614138 | Nausea | |
| 116141383 | 11614138 | Oesophagitis | |
| 116141383 | 11614138 | Pyrexia | |
| 116141383 | 11614138 | Seizure | |
| 116141383 | 11614138 | Syncope | |
| 116141383 | 11614138 | 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 |
|---|---|---|---|---|---|---|
| 116141383 | 11614138 | 1 | 20110607 | 0 | ||
| 116141383 | 11614138 | 3 | 20111021 | 0 | ||
| 116141383 | 11614138 | 5 | 2013 | 0 | ||
| 116141383 | 11614138 | 7 | 2015 | 0 | ||
| 116141383 | 11614138 | 8 | 20121217 | 0 | ||
| 116141383 | 11614138 | 9 | 20121217 | 0 | ||
| 116141383 | 11614138 | 10 | 20121217 | 0 |