FDA Adverse Events Reports (FAERS) Summary for AZOR

These tables and charts are based on 2,676 total reports for AZOR (AMLODIPINE BESYLATE\OLMESARTAN MEDOXOMIL) received by the FDA Adverse Event Reporting System (FAERS) from 2004 through April 28, 2026.

This FAERS total includes 2,596 pharmaceutical company-submitted and non-U.S. FAERS reports and 80 U.S. consumer or healthcare provider-submitted MedWatch reports. For a separate summary of the 80 U.S. reports filed via the FDA MedWatch voluntary reporting system, view our FDA MedWatch AZOR summary report. (See notes section below for explanation of FDA’s mandatory and voluntary reporting system.)

Top 20 Adverse Effects Associated with AZOR (reported in FAERS Database)

	Side Effect	# of FDA Reports
1	SPRUE-LIKE ENTEROPATHY	327
2	GASTROOESOPHAGEAL REFLUX DISEASE	214
3	DIARRHEA	201
4	DIZZINESS	193
5	WEIGHT DECREASED	179
6	ACUTE KIDNEY INJURY	172
7	NAUSEA	162
8	CHRONIC KIDNEY DISEASE	141
9	DRUG INEFFECTIVE	136
10	FATIGUE	136
11	HAEMORRHOIDS	134
12	CONSTIPATION	120
13	LACK OF STRENGTH AND ENERGY (ASTHENIA)	106
14	HEADACHE	104
15	VOMITING	95
16	FLUSHING	93
17	HIATUS HERNIA	93
18	LARGE INTESTINE POLYP	91
19	ITCHING	91
20	KIDNEY FAILURE	87
21	JOINT PAIN	80
22	LOW BLOOD PRESSURE	79
23	ANXIETY	77
24	DIVERTICULITIS	76
25	DIVERTICULUM	72
26	PAIN	72
27	SHORTNESS OF BREATH	69
28	IRRITABLE BOWEL SYNDROME	69
29	ABDOMINAL PAIN	67
30	DEHYDRATION	66
31	PAIN IN EXTREMITY	65
32	BLOOD PRESSURE INCREASED	64
33	BACK PAIN	63
34	MUSCLE SPASMS	63
35	DIVERTICULUM INTESTINAL	61
36	OFF LABEL USE	60
37	FAINTING	60
38	HIGH BLOOD PRESSURE	59
39	MALABSORPTION	59
40	FALL	58
41	SWELLING OF LIMBS	58
42	FEELING ABNORMAL	56
43	MALAISE	55
44	RASH	55
45	GASTROINTESTINAL BLEEDING	52
46	DEPRESSION	50
47	GAIT DISTURBANCE	50
48	PINS AND NEEDLES	48
49	ABDOMINAL PAIN UPPER	47
50	HAIR LOSS	46
51	ANEMIA	46
52	PNEUMONIA	46
53	INSOMNIA	45
54	COUGH	44
55	JOINT SWELLING	44
56	ABDOMINAL DISCOMFORT	42
57	WEIGHT INCREASED	40
58	CHEST PAIN	39
59	GALLSTONES	39
60	GASTRIC ULCER	39
61	INDIGESTION	38
62	TREMOR	38
63	DECREASED APPETITE	37
64	NUMBNESS	37
65	DEATH	36
66	KIDNEY FAILURE	35
67	DRUG DOSE OMISSION	34
68	MUSCLE PAIN	34
69	STROKE	33
70	COELIAC DISEASE	32
71	SKIN REDNESS	32
72	INJECTION SITE PAIN	32
73	LOWER LIMBS SWELLING	32
74	RECTAL BLEEDING	32
75	BLOOD PRESSURE DECREASED	31
76	MUSCULAR WEAKNESS	31
77	PRODUCT ADMINISTRATION ERROR	31
78	DROWSINESS	31
79	BLOOD GLUCOSE INCREASED	30
80	CONDITION AGGRAVATED	30
81	PALPITATIONS	30
82	DRUG HYPERSENSITIVITY	29
83	FEELING HOT	29
84	FEVER	29
85	BALANCE DISORDER	28
86	BLOOD IN STOOL	28
87	INCORRECT DOSE ADMINISTERED	28
88	LOSS OF CONSCIOUSNESS	27
89	URINARY TRACT INFECTION	27
90	HYPERSENSITIVITY	26
91	VISION BLURRED	25
92	PANCREATITIS	24
93	GASTRIC POLYPS	22
94	GASTRITIS	22
95	HEART RATE INCREASED	22
96	COMMON COLD	22
97	RECTAL POLYP	22
98	ABDOMINAL DISTENSION	21
99	CONGESTIVE HEART FAILURE	21
100	DRUG ADMINISTRATION ERROR	21

Latest Known Outcomes for Reactions Reported for AZOR

	Latest Known Outcome for Reported Reactions	Number of Cases
1	Unknown Outcome	1452
2	Patient has not recovered/symtoms have not resolved	792
3	Patient recovered	727
4	Patient is recovering/symptoms resolving	442
5	Patient died	67
6	Patient has recovered but has consequent health issues	6

Search all MedWatch and FAERS by keyword:

AZOR Total Reports

Male	Female	Unknown	Total
912	1127	637	2,676

Top Countries Reporting

	Country	Number of Reports
1	United States	2069
2	South Africa	42
3	Italy	12
4	EU	5
5	Switzerland	2
6	France	2
7	Puerto Rico	2
8	Portugal	2
9	Albania	1
10	Austria	1

Outcomes for Reports

Serious: 1483
Not Serious: 1193
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

Product used for unknown indication

Top Companies Reporting

Safety-Related FDA Updates

FDA Approval Date: 2007-09-26

AZOR (AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL) Rx Drug:
Safety-related Labeling Changes

Have experience (good or bad) with AZOR? Rate AZOR at Ask a Patient.

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 AZOR 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.