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
111296705	11129670	5	F	201503	20160629	20150521	20160711	EXP		US-JNJFOC-20150409271	PHARMACYCLICS		60.44	YR	A	M	Y	0.00000		20160711		MD	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	NDA NUM	DOSE AMT	DOSE UNIT	DOSE FORM	DOSE FREQ
111296705	11129670	1	SS	IMBRUVICA	IBRUTINIB	1	Oral		4200	MG	Y	U	L0407618A1;L0407619A1	0	140	MG	CAPSULE	QD
111296705	11129670	2	SS	IMBRUVICA	IBRUTINIB	1	Oral		3780	MG	Y	U	L0407618A1;L0407619A1	0	420	MG	CAPSULE	QD
111296705	11129670	3	SS	IMBRUVICA	IBRUTINIB	1	Oral		4200	MG	Y	U	L0407618A1;L0407619A1	0	280	MG	CAPSULE	QD
111296705	11129670	4	SS	IMBRUVICA	IBRUTINIB	1	Oral	140 MG, UNK	4200	MG	Y	U	L0407618A1;L0407619A1	0	140	MG	CAPSULE
111296705	11129670	5	SS	IMBRUVICA	IBRUTINIB	1	Oral		4200	MG	Y	U	L0407618A1;L0407619A1	0	420	MG	CAPSULE	QD
111296705	11129670	6	PS	IMBRUVICA	IBRUTINIB	1	Oral				Y	U	L0407618A1;L0407619A1	205552	420	MG	CAPSULE
111296705	11129670	7	SS	CRESTOR	ROSUVASTATIN CALCIUM	1	Oral	10 MG, Q AM			Y			0	5	MG		QD
111296705	11129670	8	SS	CRESTOR	ROSUVASTATIN CALCIUM	1	Oral				Y			0
111296705	11129670	9	SS	CRESTOR	ROSUVASTATIN CALCIUM	1	Oral				Y			0
111296705	11129670	10	SS	CRESTOR	ROSUVASTATIN CALCIUM	1	Oral	10 MG, Q AM			Y			0	5	MG		QD
111296705	11129670	11	C	LISINOPRIL.	LISINOPRIL	1	Oral							0	5	MG		BID
111296705	11129670	12	C	PREVACID	LANSOPRAZOLE	1	Oral	15 MG, Q AM						0	15	MG		QD
111296705	11129670	13	C	ZANTAC	RANITIDINE HYDROCHLORIDE	1	Oral	150 MG, Q AM						0	150	MG	UNSPECIFIED	QD
111296705	11129670	14	C	FLUTICASONE	FLUTICASONEFLUTICASONE PROPIONATE	1	Nasal	1 PUFF IN EACH NOSTRIL Q AM						0	1	DF		QD
111296705	11129670	15	C	CIALIS	TADALAFIL	1	Oral	5 MG. QHS						0	5	MG
111296705	11129670	16	C	METFORMIN	METFORMIN HYDROCHLORIDE	1	Oral							0	500	MG		TID
111296705	11129670	17	C	UROCIT-K	POTASSIUM CITRATE	1	Oral							0	50	MEQ		BID
111296705	11129670	18	C	LOVAZA	OMEGA-3-ACID ETHYL ESTERS	1	Oral							0
111296705	11129670	19	C	LOVAZA	OMEGA-3-ACID ETHYL ESTERS	1	Oral							0	1	G		TID
111296705	11129670	20	C	LOVAZA	OMEGA-3-ACID ETHYL ESTERS	1	Oral							0	1	G		TID
111296705	11129670	21	C	LOVAZA	OMEGA-3-ACID ETHYL ESTERS	1	Oral							0
111296705	11129670	22	C	BENADRYL	DIPHENHYDRAMINE HYDROCHLORIDE	1	Oral	25-50 MG QHS						0			UNSPECIFIED
111296705	11129670	23	C	MELATONIN	MELATONIN	1	Oral	QHS						0	3	MG
111296705	11129670	24	C	VITAMIN D3	CHOLECALCIFEROL	1		M, W, F						0	5000	IU
111296705	11129670	25	C	FISH OIL	FISH OIL	1								0

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
111296705	11129670	1	Chronic lymphocytic leukaemia
111296705	11129670	2	Chronic lymphocytic leukaemia
111296705	11129670	3	Chronic lymphocytic leukaemia
111296705	11129670	4	Chronic lymphocytic leukaemia
111296705	11129670	5	Chronic lymphocytic leukaemia
111296705	11129670	6	Chronic lymphocytic leukaemia
111296705	11129670	7	Hyperlipidaemia
111296705	11129670	8	Hyperlipidaemia
111296705	11129670	9	Hypercholesterolaemia
111296705	11129670	10	Hypercholesterolaemia
111296705	11129670	11	Hypertension
111296705	11129670	12	Gastrooesophageal reflux disease
111296705	11129670	13	Gastrooesophageal reflux disease
111296705	11129670	14	Chronic sinusitis
111296705	11129670	16	Type 2 diabetes mellitus
111296705	11129670	17	Nephrolithiasis
111296705	11129670	18	Hyperlipidaemia
111296705	11129670	19	Hyperlipidaemia
111296705	11129670	20	Hypercholesterolaemia
111296705	11129670	21	Hypercholesterolaemia
111296705	11129670	22	Sleep disorder
111296705	11129670	23	Sleep disorder

Outcome of event

Event ID	CASEID	OUTC COD
111296705	11129670	OT

Reactions reported

Event ID	CASEID	PT
111296705	11129670	Alanine aminotransferase increased
111296705	11129670	Diarrhoea
111296705	11129670	Dizziness
111296705	11129670	Fatigue
111296705	11129670	Haematuria
111296705	11129670	Lymphadenopathy
111296705	11129670	Nephrolithiasis
111296705	11129670	Oral fungal infection
111296705	11129670	Paranasal sinus hypersecretion
111296705	11129670	Platelet count decreased
111296705	11129670	Rotator cuff syndrome
111296705	11129670	Sinus congestion

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
111296705	11129670	1	20150406	201504
111296705	11129670	2	20150324	20150401
111296705	11129670	3	201504
111296705	11129670	4	2015	201505
111296705	11129670	5	2015	20150430
111296705	11129670	6	2015
111296705	11129670	7		20150430
111296705	11129670	10		20150430
111296705	11129670	19		2015
111296705	11129670	20		2015
111296705	11129670	24		20150430