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
126990952	12699095	2	F		20160906	20160830	20160915	EXP		DE-APOTEX-2016AP010732	APOTEX	KRUGER T, JOCKERS-SCHERUBL M, GROHMANN R, RUTHER E, DEGNER D.. DEVELOPMENT OF EPILEPTIC SEIZURES UNDER THERAPY WITH OLANZAPINE AND VENLAFAXINE ER WITH FATAL OUTCOME.. PSYCHOPHARMAKOTHERAPIE. 2016;23(5):125-128	76.00	YR		F	Y	0.00000		20160915		MD	DE	DE

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	NDA NUM	DOSE AMT	DOSE UNIT	DOSE FORM	DOSE FREQ
126990952	12699095	1	PS	OLANZAPINE APOTEX	OLANZAPINE	1	Unknown	5 MG AT NIGHT					90798	5	MG	TABLET	QD
126990952	12699095	2	SS	OLANZAPINE APOTEX	OLANZAPINE	1	Unknown	2.5 MG/ DAY					90798	2.5	MG	TABLET
126990952	12699095	3	SS	PRADAXA	DABIGATRAN ETEXILATE MESYLATE	1	Oral	110 MG, BID AT ADMISSION					0	110	MG		BID
126990952	12699095	4	SS	VENLAFAXINE	VENLAFAXINE HYDROCHLORIDE	1	Unknown	EXTENDED RELEASE 37.5 MG	112.5	MG			0	37.5	MG
126990952	12699095	5	SS	VENLAFAXINE	VENLAFAXINE HYDROCHLORIDE	1	Unknown	EXTENDED RELEASE 75 MG	112.5	MG			0	75	MG
126990952	12699095	6	SS	VENLAFAXINE	VENLAFAXINE HYDROCHLORIDE	1	Unknown	EXTENDED RELEASE 112.5 MG	112.5	MG			0	112.5	MG
126990952	12699095	7	SS	PREDNISOLONE.	PREDNISOLONE	1	Unknown	5 MG/ DAY					0	5	MG
126990952	12699095	8	SS	METHOTREXATE.	METHOTREXATE	1	Unknown	15 MG/WEEK					0
126990952	12699095	9	C	AMITRIPTYLINE	AMITRIPTYLINE	1	Unknown	30 MG, UNK					0	30	MG
126990952	12699095	10	C	DOXEPIN	DOXEPIN	1	Unknown	25 MG, UNK					0	25	MG
126990952	12699095	11	C	PANTOPRAZOLE	PANTOPRAZOLE SODIUM	1	Unknown	40 MG/DAY			U	U	0
126990952	12699095	12	C	NALOXONE W/OXYCODONE	NALOXONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE	1	Unknown	10/5 MG TWICE DAILY				U	0
126990952	12699095	13	SS	LORAZEPAM.	LORAZEPAM	1	Unknown	0.5 MG X 2 (DAY 5 AND DAY 6 OF DEPRESSION TREATMENT)	.75	MG			0
126990952	12699095	14	SS	LORAZEPAM.	LORAZEPAM	1	Unknown	1 MG, UNK	.75	MG			0	1	MG
126990952	12699095	15	SS	LORAZEPAM.	LORAZEPAM	1	Unknown	0.75 MG, UNK	.75	MG			0	.75	MG
126990952	12699095	16	SS	LORAZEPAM.	LORAZEPAM	1	Unknown	0.5 MG, UNK	.75	MG			0	.5	MG
126990952	12699095	17	SS	LORAZEPAM.	LORAZEPAM	1	Unknown	0.25 MG, UNK	.75	MG			0	.25	MG
126990952	12699095	18	C	FESOTERODINE	FESOTERODINE	1	Unknown	8 MG/DAY			U	U	0	8	MG
126990952	12699095	19	C	CALCIUM	CALCIUM	1	Unknown	500 MG/DAY			U	U	0	500	MG
126990952	12699095	20	C	COLECALCIFEROL	CHOLECALCIFEROL	1	Unknown	1 X /WEEK			U	U	0

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
126990952	12699095	1	Sleep disorder
126990952	12699095	2	Mood altered
126990952	12699095	3	Anticoagulant therapy
126990952	12699095	4	Antidepressant therapy
126990952	12699095	7	Rheumatoid arthritis
126990952	12699095	8	Rheumatoid arthritis
126990952	12699095	9	Sleep disorder
126990952	12699095	10	Sleep disorder
126990952	12699095	11	Product used for unknown indication
126990952	12699095	12	Pain
126990952	12699095	13	Anxiolytic therapy
126990952	12699095	18	Product used for unknown indication
126990952	12699095	19	Product used for unknown indication
126990952	12699095	20	Product used for unknown indication

Outcome of event

Event ID	CASEID	OUTC COD
126990952	12699095	DE
126990952	12699095	OT
126990952	12699095	HO

Reactions reported

Event ID	CASEID	PT
126990952	12699095	Circulatory collapse
126990952	12699095	Generalised tonic-clonic seizure
126990952	12699095	Haematoma
126990952	12699095	Haemorrhage
126990952	12699095	Multiple fractures

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

no results found

no results found

Therapies reported

no results found

no results found