FDA Adverse Events Reports (FAERS) Summary for AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE

These tables and charts are based on 682 total reports for AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE (AMLODIPINE BESYLATE\BENAZEPRIL HYDROCHLORIDE) received by the FDA Adverse Event Reporting System (FAERS) from 2004 through April 28, 2026.

This FAERS total includes 614 pharmaceutical company-submitted and non-U.S. FAERS reports and 68 U.S. consumer or healthcare provider-submitted MedWatch reports. For a separate summary of the 68 U.S. reports filed via the FDA MedWatch voluntary reporting system, view our FDA MedWatch AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE summary report. (See notes section below for explanation of FDA’s mandatory and voluntary reporting system.)

Top 20 Adverse Effects Associated with AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE (reported in FAERS Database)

	Side Effect	# of FDA Reports
1	DRUG INEFFECTIVE	51
2	DIARRHEA	46
3	FATIGUE	46
4	COMPLETED SUICIDE	37
5	NAUSEA	37
6	CHRONIC KIDNEY DISEASE	36
7	KIDNEY FAILURE	33
8	SHORTNESS OF BREATH	31
9	HEADACHE	31
10	ACUTE KIDNEY INJURY	28
11	VOMITING	27
12	LACK OF STRENGTH AND ENERGY (ASTHENIA)	25
13	DEATH	24
14	ANXIETY	23
15	PAIN	23
16	DIZZINESS	22
17	WEIGHT DECREASED	21
18	JOINT PAIN	20
19	OFF LABEL USE	20
20	PRODUCT SUBSTITUTION ISSUE	20
21	ANGIOEDEMA	19
22	BLOOD PRESSURE INCREASED	19
23	COUGH	19
24	FALL	18
25	PAIN IN EXTREMITY	18
26	HIGH BLOOD PRESSURE	17
27	PNEUMONIA	17
28	ITCHING	17
29	MALAISE	16
30	ABDOMINAL DISCOMFORT	15
31	CONSTIPATION	15
32	MUSCLE SPASMS	15
33	PRODUCT DOSE OMISSION ISSUE	15
34	DEHYDRATION	14
35	INSOMNIA	14
36	FEELING ABNORMAL	13
37	LOWER LIMBS SWELLING	12
38	ABDOMINAL PAIN UPPER	11
39	HAIR LOSS	11
40	BACK PAIN	11
41	CHEST PAIN	11
42	HYPERSENSITIVITY	11
43	RASH	11
44	URINARY TRACT INFECTION	11
45	ABDOMINAL DISTENSION	10
46	COVID-19	10
47	DEPRESSION	10
48	KIDNEY FAILURE	10
49	INJECTION SITE PAIN	10
50	MUSCLE PAIN	10
51	COMMON COLD	10
52	DECREASED APPETITE	9
53	HOT FLUSH	9
54	LOW BLOOD PRESSURE	9
55	LOSS OF CONSCIOUSNESS	9
56	PRODUCT USE ISSUE	9
57	THROMBOSIS	9
58	BALANCE DISORDER	8
59	DISEASE PROGRESSION	8
60	DRUG HYPERSENSITIVITY	8
61	SKIN REDNESS	8
62	SWELLING OF LIMBS	8
63	PRODUCT ODOUR ABNORMAL	8
64	CONFUSIONAL STATE	7
65	METALLIC OR ALTERED TASTE	7
66	INDIGESTION	7
67	BREATHLESSNESS	7
68	GAIT DISTURBANCE	7
69	HAEMOGLOBIN DECREASED	7
70	HYPERPARATHYROIDISM SECONDARY	7
71	NUMBNESS	7
72	INFECTION	7
73	INFLUENZA	7
74	JOINT SWELLING	7
75	NEPHROGENIC ANAEMIA	7
76	URINATION DIFFICULTY	7
77	PRODUCT QUALITY ISSUE	7
78	KIIDNEY INJURY	7
79	WEIGHT INCREASED	7
80	WHITE BLOOD CELL COUNT DECREASED	7
81	BLOOD PRESSURE DECREASED	6
82	BRONCHITIS	6
83	DRUG DOSE OMISSION	6
84	DIFFICULTY SWALLOWING	6
85	EMOTIONAL DISTRESS	6
86	PANCREATITIS	6
87	SEPSIS	6
88	TREMOR	6
89	TUBULOINTERSTITIAL NEPHRITIS	6
90	HIVES	6
91	VISUAL IMPAIRMENT	6
92	ABDOMINAL PAIN	5
93	ANEMIA	5
94	LOSS OF ALL PLEASURE	5
95	ASTHMA	5
96	ATRIAL FIBRILLATION	5
97	BLOOD BILIRUBIN INCREASED	5
98	BLOOD GLUCOSE INCREASED	5
99	CONGESTIVE HEART FAILURE	5
100	CHEST DISCOMFORT	5

Latest Known Outcomes for Reactions Reported for AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE

	Latest Known Outcome for Reported Reactions	Number of Cases
1	Unknown Outcome	413
2	Patient has not recovered/symtoms have not resolved	172
3	Patient recovered	103
4	Patient died	58
5	Patient is recovering/symptoms resolving	39
6	Patient has recovered but has consequent health issues	2

Search all MedWatch and FAERS by keyword:

AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE Total Reports

Male	Female	Unknown	Total
327	305	50	682

Top Countries Reporting

	Country	Number of Reports
1	United States	620
2	China	7
3	Brazil	2
4	Australia	1
5	Denmark	1
6	Puerto Rico	1

Outcomes for Reports

Serious: 378
Not Serious: 303
Note: A serious outcome means the adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition.

Top Indications

HIGH BLOOD PRESSURE

Top Companies Reporting

Safety-Related FDA Updates

For serious adverse events, report them to the FDA by contacting the drug manufacturer or report directly through the MedWatch voluntary reporting form.

Notes

This report, created by AskaPatient.com, is derived from the cases for AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE reported to the United States Food and Drug Administration (FDA) FDA Safety Information and Adverse Event Reporting System (FAERS) and obtained from Open FDA. Data was last updated with reports received through April 28, 2026.

This summary includes ALL reports where the drug is a "primary OR secondary OR suspected interacting" drug. Typically, reports are filed for the most serious type or "event" and do not represent incidental or minor side effects. The majority of these reports are mandatory reports submitted by pharmaceutical companies, who receive complaints from consumers. The reactions, side effects, or "adverse events," represent up to the 20 most frequently occuring events in the database for a drug related to the event. This report also features counts of latest known outcomes associated with reported side effects, but does not provide the specific outcomes for specific adverse events.

Adverse Event Reports are submitted to the FAERS database by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers). Health care providers such as doctors (voluntary reporting), and patients themselves (voluntary reporting) report to the FDA directly through the MedWatch program. Those MedWatch reports are coded and included in the FAERS database. This report mainly consists of the mandatory reports, because the MedWatch reports are a small percentage (3 - 5%) of total reports. Link to the MedWatch summary report at the top of the page for a summary of the directly reported (voluntary) adverse events for this drug.The number of reports included here might differ somewhat from the number of reports in the downloadable quarterly FAERS reports and in the online FAERS dashboard, due to lags in reporting, drug name differences, duplicates, and other factors. Open FDA states that it only includes the most recent version of a case report. It also adds the disclaimer: "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated."

FDA uses the "MedDRA" classification system to describe reported adverse reactions. MedDRA is a standardized medical terminology that facilitates sharing of regulatory information internationally. In some cases, "patient friendly" terms for the layman designated by MedDRA have been substituted for medical jargon. Please contact us with questions or comments about this report.