AMLODIPINE BESYLATE FDA MedWatch Voluntary U.S. Reports Summary

These tables and charts are created from 2,711 U.S. reports for AMLODIPINE BESYLATE (AMLODIPINE BESYLATE) voluntarily reported by individuals directly to the FDA via the MedWatch Reporting System from 2004 through July 30, 2026. Events listed on this page represent serious and often rare adverse events reported to the FDA, and often do not represent typical side effects for the medication. Find common side effects on the most recent official drug label.

For a summary of adverse events including mandatory reports submitted by pharmaceutical companies (all countries and all reporter types) to the FAERS database, View FDA FAERS AMLODIPINE BESYLATE Report.

Top Adverse Events Reported with AMLODIPINE BESYLATE (from U.S. FDA Medwatch Reports)

	Side Effect	# of FDA Reports
1	DEATH	266
2	DIZZINESS	158
3	NAUSEA	152
4	FATIGUE	142
5	HEADACHE	138
6	PRODUCT SUBSTITUTION ISSUE	112
7	SHORTNESS OF BREATH	111
8	LACK OF STRENGTH AND ENERGY (ASTHENIA)	110
9	DIARRHEA	110
10	DISEASE PROGRESSION	109
11	DRUG INEFFECTIVE	92
12	PAIN IN EXTREMITY	85
13	ITCHING	85
14	RASH	85
15	JOINT PAIN	81
16	PAIN	80
17	VOMITING	77
18	LOWER LIMBS SWELLING	76
19	BLOOD PRESSURE INCREASED	73
20	ANGIOEDEMA	70
21	THERAPY CESSATION	66
22	THERAPY INTERRUPTED	66
23	INSOMNIA	63
24	FALL	62
25	BACK PAIN	60

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AMLODIPINE BESYLATE Total Medwatch Safety Reports by Patient Sex

Male	Female	Unknown	Total
1252	1389	70	2,711

Medwatch Reporter Type	Count
Consumer	1053
Physician	191
Pharmacist	462
Other Health Professional	454

Top Indications

Product used for unknown indication
HIGH BLOOD PRESSURE
Secondary progressive multiple sclerosis
Blood pressure abnormal
Essential hypertension

Type of Outcome Reported
Serious: 1839
Not Serious: 872
Note: A serious outcome means the adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition.

Suspected Role
Primary Suspect: 2711
Concomitant Drugs: 2396
Note: A single MedWatch report can list more than one drug. This summary includes AMLODIPINE BESYLATE identified as the suspect drug or as a concomitantly taken drug.

FDA Safety-Related Labeling Changes

NORVASC (AMLODIPINE BESYLATE) Rx Drug:
FDA Safety-related Labeling Changes

LOTREL (AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE) Rx Drug:
FDA Safety-related Labeling Changes

CADUET (AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM) Rx Drug:
FDA Safety-related Labeling Changes

Risk of myasthenia gravis or general muscle weakness

CADUET (AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM) Rx Drug:
FDA Safety-related Labeling Changes

Risk of liver injury

EXFORGE (AMLODIPINE BESYLATE; VALSARTAN) Rx Drug:
FDA Safety-related Labeling Changes

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

TWYNSTA (AMLODIPINE BESYLATE; TELMISARTAN) Rx Drug:
FDA Safety-related Labeling Changes

TRIBENZOR (AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL) Rx Drug:
FDA Safety-related Labeling Changes

PRESTALIA (AMLODIPINE BESYLATE; PERINDOPRIL ARGININE) Rx Drug:
FDA Safety-related Labeling Changes

Have experience (good or bad) with PRESTALIA? Rate PRESTALIA 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 U.S. drug-related adverse event cases that were reported directly to the FDA using the voluntary MedWatch online or paper reporting system. MedWatch is the voluntary FDA system for consumers, physicians, and others to directly report adverse reactions. The Medwatch initiative was launched in 1993 as a voluntary reporting program for consumers, physicians and other healthcare practitioners.

After processing the received forms, the FDA adds the MedWatch reports to the FDA Adverse Events Reporting System(or FAERS database.) Click here for the complete FAERS report summary, which includes mandatory reports submitted by pharmaceutical companies (worldwide) combined with the MedWatch reports. MedWatch Reports only represent about 5% of the FAERS database. For more, read "Does the FDA's Rapidly Growing Database of Adverse Events Improve Drug Safety?"

The data in this report was obtained from Open FDA. Data was last updated to include reports through January 27, 2026. 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.

Open FDA states that it only includes the most recent version of a case report. It also adds the disclaimer: "Do not rely on Open FDA 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 about this report.