AMLODIPINE\ATORVASTATIN: 636 Adverse Event Reports & Safety Profile

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636

Total FAERS Reports

44 (6.9%)

Deaths Reported

133

Hospitalizations

636

As Primary/Secondary Suspect

Life-Threatening

Disabilities

Active Ingredient: AMLODIPINE BESYLATE\ATORVASTATIN CALCIUM ·

First Report: 1988 · Latest Report: 20250506

What Are the Most Common AMLODIPINE\ATORVASTATIN Side Effects?

#1 Most Reported

Malaise

55 reports (8.6%)

#2 Most Reported

Type 2 diabetes mellitus

38 reports (6.0%)

#3 Most Reported

Drug ineffective

31 reports (4.9%)

Side Effect	Reports	% of Total	Deaths	Hosp.
Malaise	55	8.7%	1	11
Type 2 diabetes mellitus	38	6.0%	1	7
Drug ineffective	31	4.9%	0	2
Drug hypersensitivity	30	4.7%	0	0
Death	28	4.4%	28	0
Dizziness	23	3.6%	1	6
Pain	23	3.6%	0	4
Hypertension	21	3.3%	0	3
Hypoacusis	21	3.3%	0	2
Memory impairment	21	3.3%	0	2
Dyspnoea	19	3.0%	0	10
Cerebrovascular accident	18	2.8%	1	6
Feeling abnormal	18	2.8%	0	3
Fall	17	2.7%	0	9
Blood pressure inadequately controlled	16	2.5%	0	6
Cardiac disorder	16	2.5%	2	4
Gait disturbance	16	2.5%	0	6
Myocardial infarction	16	2.5%	3	4
Diabetes mellitus	14	2.2%	0	3
Headache	14	2.2%	0	2

Gender: 59.0% female, 41.0% male. Average age: 69.5 years. Most reports from: US. View detailed demographics →

Year	Reports	Deaths	Hosp.
2001	1	0	0
2004	4	0	0
2005	4	0	1
2006	5	0	0
2007	6	0	0
2008	3	1	0
2009	7	1	0
2010	3	0	1
2011	1	0	0
2012	10	0	5
2013	13	2	5
2014	29	2	10
2015	32	4	15
2016	25	1	8
2017	29	2	19
2018	13	1	6
2019	17	0	4
2020	17	4	3
2021	12	3	3
2022	11	0	8
2023	15	2	5
2024	7	0	3
2025	4	0	0

Indication	Reports
Hypertension	145
Blood cholesterol increased	57
Product used for unknown indication	46
Blood pressure abnormal	41
Blood cholesterol abnormal	38
Blood cholesterol	27
Blood pressure measurement	18
Hyperlipidaemia	17
Hypercholesterolaemia	13
Cardiac disorder	12

Official prescribing information from the FDA-approved drug label.