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
930456612	9304566	12	F	2012	20160822	20130523	20160824	EXP		CA-ROCHE-1156681	ROCHE		71.78	YR		F	Y	72.70000	KG	20160824		MD	CA	CA

Drug(s) used by person

Event ID	CASEID	DRUG SEQ	ROLE COD	DRUGNAME	PROD AI	VAL VBM	ROUTE	DOSE VBM	DECHAL	LOT NUM	NDA NUM	DOSE AMT	DOSE UNIT	DOSE FORM
930456612	9304566	1	PS	ACTEMRA	TOCILIZUMAB	1	Intravenous (not otherwise specified)	EVERY 4 WEEKS	Y	B2013B011,B2015B111,B2007B281,B2062	125276	672	MG	SOLUTION FOR INFUSION
930456612	9304566	2	SS	ACTEMRA	TOCILIZUMAB	1	Intravenous (not otherwise specified)	EVERY 4 WEEKS	Y	B2013B011,B2015B111,B2007B281,B2062	125276	664	MG	SOLUTION FOR INFUSION
930456612	9304566	3	SS	ACTEMRA	TOCILIZUMAB	1	Intravenous (not otherwise specified)		Y	B2013B011,B2015B111,B2007B281,B2062	125276	640	MG	SOLUTION FOR INFUSION
930456612	9304566	4	SS	ACTEMRA	TOCILIZUMAB	1	Intravenous (not otherwise specified)		Y	B2013B011,B2015B111,B2007B281,B2062	125276	672	MG	SOLUTION FOR INFUSION
930456612	9304566	5	SS	ACTEMRA	TOCILIZUMAB	1	Intravenous (not otherwise specified)		Y	B2013B011,B2015B111,B2007B281,B2062	125276	580	MG	SOLUTION FOR INFUSION
930456612	9304566	6	SS	ACTEMRA	TOCILIZUMAB	1	Intravenous (not otherwise specified)		Y	B2013B011,B2015B111,B2007B281,B2062	125276	656	MG	SOLUTION FOR INFUSION
930456612	9304566	7	SS	NAPROXEN.	NAPROXEN	1	Unknown		U		17581	375	MG
930456612	9304566	8	SS	RITUXAN	RITUXIMAB	1	Intravenous (not otherwise specified)				103705	1000	MG	SOLUTION FOR INFUSION
930456612	9304566	9	C	SYNTHROID	LEVOTHYROXINE SODIUM	1					0
930456612	9304566	10	C	COZAAR	LOSARTAN POTASSIUM	1					0
930456612	9304566	11	C	PREMARIN	ESTROGENS, CONJUGATED	1					0
930456612	9304566	12	C	VOLTAREN	DICLOFENAC SODIUM	1					0
930456612	9304566	13	C	SINGULAIR	MONTELUKAST SODIUM	1					0
930456612	9304566	14	C	ACTONEL	RISEDRONATE SODIUM	1					0
930456612	9304566	15	C	ADVAIR HFA	FLUTICASONE PROPIONATESALMETEROL XINAFOATE	1					0
930456612	9304566	16	C	VENTOLIN	ALBUTEROL SULFATE	1					0
930456612	9304566	17	C	CIMZIA	CERTOLIZUMAB PEGOL	1	Unknown				0
930456612	9304566	18	C	ADVIL	IBUPROFEN	1	Unknown				0
930456612	9304566	19	C	ADVIL	IBUPROFEN	1	Unknown				0
930456612	9304566	20	C	REACTINE (CANADA)	CETIRIZINE HYDROCHLORIDE	1	Oral				0	10	MG
930456612	9304566	21	C	REACTINE (CANADA)	CETIRIZINE HYDROCHLORIDE	1	Oral				0	200	MG
930456612	9304566	22	C	SOLU-CORTEF	HYDROCORTISONE SODIUM SUCCINATE	1	Intravenous (not otherwise specified)				0	250	MG
930456612	9304566	23	C	SOLU-CORTEF	HYDROCORTISONE SODIUM SUCCINATE	1	Intravenous (not otherwise specified)				0	250	MG
930456612	9304566	24	C	CORTISONE	CORTISONEHYDROCORTISONE	1	Unknown				0

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
930456612	9304566	1	Rheumatoid arthritis
930456612	9304566	7	Product used for unknown indication
930456612	9304566	8	Rheumatoid arthritis

Outcome of event

Event ID	CASEID	OUTC COD
930456612	9304566	LT
930456612	9304566	OT

Reactions reported

Event ID	CASEID	PT
930456612	9304566	Bronchitis
930456612	9304566	Cough
930456612	9304566	Dyspnoea
930456612	9304566	Fatigue
930456612	9304566	Infection
930456612	9304566	Joint swelling
930456612	9304566	Latent tuberculosis
930456612	9304566	Myocardial infarction
930456612	9304566	Osteoarthritis
930456612	9304566	Pain
930456612	9304566	Rash
930456612	9304566	Rheumatoid arthritis
930456612	9304566	Urticaria
930456612	9304566	Weight fluctuation

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
930456612	9304566	1	20130509
930456612	9304566	2	20120813
930456612	9304566	3	20130607
930456612	9304566	4	20130702
930456612	9304566	5	20131003
930456612	9304566	6	20140403
930456612	9304566	8	20110510	20110526
930456612	9304566	17		20120602
930456612	9304566	18		20120602
930456612	9304566	19	20110510	20110510
930456612	9304566	20	20110510	20110510
930456612	9304566	21	20130510	20130510
930456612	9304566	22	20110510	20110510
930456612	9304566	23	20130510	20130510
930456612	9304566	24	20140319