Safety Rates Drug Report: adverse events in 2016 Q3 - FDA prescription drugs adverse events in an open, searchable, online, public database

Drug Injury Quarter

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
126237811	12623781	1	I	201511	20160226	20160804	20160804	PER		US-JAZZ-2016-US-003840	JAZZ		48.62	YR		F	Y	0.00000		20160804			US	US

Drug(s) used by person

Event ID	CASEID	DRUG SEQ	ROLE COD	DRUGNAME	PROD AI	VAL VBM	ROUTE	DOSE VBM	DECHAL	RECHAL	NDA NUM	DOSE AMT	DOSE UNIT	DOSE FORM
126237811	12623781	1	PS	XYREM	SODIUM OXYBATE	1	Oral	2.25 G, BID			21196	2.25	G	ORAL SOLUTION
126237811	12623781	2	SS	XYREM	SODIUM OXYBATE	1	Oral	3 G, BID			21196	3	G	ORAL SOLUTION
126237811	12623781	3	SS	XYREM	SODIUM OXYBATE	1	Oral	4.5 G, BID			21196	4.5	G	ORAL SOLUTION
126237811	12623781	4	SS	URIBEL	HYOSCYAMINE SULFATEMETHENAMINEMETHYLENE BLUEPHENYL SALICYLATESODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	1		UNK	Y		0			CAPSULE
126237811	12623781	5	SS	Imipramine	IMIPRAMINE	1		UNK	Y		0			TABLET
126237811	12623781	6	SS	PRISTIQ EXTENDED-RELEASE	DESVENLAFAXINE SUCCINATE	1		UNK	U		0			TABLET
126237811	12623781	7	C	Calcium +D	CALCIUMVITAMIN D	1		UNK		U	0			CHEWABLE TABLET
126237811	12623781	8	C	Fish oil concentrate		2		UNK		U	0
126237811	12623781	9	C	Multivitamins	VITAMINS	1		UNK		U	0			TABLET
126237811	12623781	10	C	PREMARIN	ESTROGENS, CONJUGATED	1		UNK		U	0
126237811	12623781	11	C	VESICARE	SOLIFENACIN SUCCINATE	1		UNK		U	0			TABLET
126237811	12623781	12	C	VITAMIN B COMPLEX	CYANOCOBALAMINDEXPANTHENOLNIACINAMIDEPYRIDOXINE HYDROCHLORIDERIBOFLAVIN 5'-PHOSPHATE SODIUMTHIAMINE HYDROCHLORIDEVITAMIN B COMPLEX	1		UNK		U	0			CAPSULE
126237811	12623781	13	C	PROGESTERONE.	PROGESTERONE	1		UNK		U	0			CAPSULE
126237811	12623781	14	C	Azelastine	AZELASTINE	1		UNK		U	0			NASAL SPRAY
126237811	12623781	15	C	FLUTICASONE PROPIONATE.	FLUTICASONE PROPIONATE	1		UNK		U	0			SPRAY
126237811	12623781	16	C	LINZESS	LINACLOTIDE	1		UNK		U	0			CAPSULE
126237811	12623781	17	C	SPIRONOLACTONE.	SPIRONOLACTONE	1		UNK		U	0			TABLET
126237811	12623781	18	C	TOVIAZ	FESOTERODINE FUMARATE	1		UNK		U	0			TABLET
126237811	12623781	19	C	AMNESTEEM	ISOTRETINOIN	1		UNK		U	0			CAPSULE
126237811	12623781	20	C	KLONOPIN	CLONAZEPAM	1		UNK		U	0			TABLET
126237811	12623781	21	C	LEVOTHYROXINE.	LEVOTHYROXINE	1		UNK		U	0			TABLET
126237811	12623781	22	C	METFORMIN	METFORMIN HYDROCHLORIDE	1		UNK		U	0			TABLET
126237811	12623781	23	C	METHYLPHENIDATE.	METHYLPHENIDATE	1		UNK		U	0			TABLET
126237811	12623781	24	C	NUVIGIL	ARMODAFINIL	1		UNK		U	0			TABLET
126237811	12623781	25	C	ACZONE	DAPSONE	1		UNK		U	0			GEL
126237811	12623781	26	C	HYOSCYAMINE SULFATE.	HYOSCYAMINE SULFATE	1		UNK		U	0			TABLET
126237811	12623781	27	C	PROGESTERONE.	PROGESTERONE	1		UNK		U	0			CAPSULE
126237811	12623781	28	C	TRETINOIN.	TRETINOIN	1		UNK		U	0			CREAM

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
126237811	12623781	1	Narcolepsy
126237811	12623781	2	Cataplexy
126237811	12623781	4	Product used for unknown indication
126237811	12623781	5	Product used for unknown indication
126237811	12623781	6	Product used for unknown indication
126237811	12623781	7	Product used for unknown indication
126237811	12623781	8	Product used for unknown indication
126237811	12623781	9	Product used for unknown indication
126237811	12623781	10	Product used for unknown indication
126237811	12623781	11	Product used for unknown indication
126237811	12623781	12	Product used for unknown indication
126237811	12623781	13	Product used for unknown indication
126237811	12623781	14	Product used for unknown indication
126237811	12623781	15	Product used for unknown indication
126237811	12623781	16	Product used for unknown indication
126237811	12623781	17	Product used for unknown indication
126237811	12623781	18	Product used for unknown indication
126237811	12623781	19	Product used for unknown indication
126237811	12623781	20	Product used for unknown indication
126237811	12623781	21	Product used for unknown indication
126237811	12623781	22	Product used for unknown indication
126237811	12623781	23	Product used for unknown indication
126237811	12623781	24	Product used for unknown indication
126237811	12623781	25	Product used for unknown indication
126237811	12623781	26	Product used for unknown indication
126237811	12623781	27	Product used for unknown indication
126237811	12623781	28	Product used for unknown indication

Outcome of event

no results found

no results found

Reactions reported

Event ID	CASEID	PT
126237811	12623781	Attention deficit/hyperactivity disorder
126237811	12623781	Burning sensation
126237811	12623781	Cervical radiculopathy
126237811	12623781	Drug interaction
126237811	12623781	Dysuria
126237811	12623781	Enuresis
126237811	12623781	Hormone level abnormal
126237811	12623781	Pain
126237811	12623781	Photopsia
126237811	12623781	Pre-existing condition improved
126237811	12623781	Pyrexia
126237811	12623781	Therapeutic response unexpected
126237811	12623781	Unevaluable event

Reporting Sources (this data is often not reported and may therefore be missing here)

no results found

no results found

Therapies reported

Event ID	CASEID	DSG DRUG SEQ	START DT	END DT
126237811	12623781	1	201307	201307
126237811	12623781	2	201307	2013
126237811	12623781	3	201308
126237811	12623781	4	20130709	20160226
126237811	12623781	5	20150731	20160226
126237811	12623781	6	20130709
126237811	12623781	7	20151013
126237811	12623781	8	20151013
126237811	12623781	9	20151013
126237811	12623781	10	20151013
126237811	12623781	11	20151013	20160226
126237811	12623781	12	20151013
126237811	12623781	13	20150731	20160226
126237811	12623781	14	20150123	20160226
126237811	12623781	15	20150123	20160226
126237811	12623781	16	20150105	20160226
126237811	12623781	17	20140901
126237811	12623781	18	20130730	20150731
126237811	12623781	19	20130709	20131122
126237811	12623781	20	20130709	20160309
126237811	12623781	21	20130709
126237811	12623781	22	20130709
126237811	12623781	23	20130709
126237811	12623781	24	20130709