VARENICLINE for Smoking cessation therapy: Side Effects & Safety Data

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There are 9,055 adverse event reports in the FDA FAERS database where VARENICLINE was used for Smoking cessation therapy.

Most Reported Side Effects for VARENICLINE

Side Effect	Reports	%	Deaths	Hosp.
Drug ineffective	2,625	12.9%	6	92
Nausea	2,232	10.9%	7	118
Abnormal dreams	1,656	8.1%	4	59
Malaise	986	4.8%	12	96
Depression	979	4.8%	34	121
Nightmare	978	4.8%	10	57
Feeling abnormal	864	4.2%	11	68
Insomnia	833	4.1%	9	85
Vomiting	777	3.8%	1	93
Drug hypersensitivity	729	3.6%	0	28
Sneezing	725	3.6%	0	3
Anxiety	698	3.4%	10	90
Headache	679	3.3%	3	64
Suicidal ideation	662	3.2%	13	102
Dyspnoea	478	2.3%	7	114