Pharmacologic class (EPC) · 6 drug pages

Calcium channel blocker: adverse event reports filed with FDA

76,049 reports list a drug in this class as a suspect or interacting product, 2004–2026.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event." The information in these reports "cannot be used to estimate the incidence of these events."

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.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

76,049
reports across the class: 0.4% of all reports; 5,126
reports, 12 months to June 2026: 5,584 in the 12 months before; 87.7%
marked serious by the reporter: 57.4% across all reports; 6
drugs with a page: brand and generic names counted separately

Calcium channel blocker is a pharmacologic class (an FDA Established Pharmacologic Class) with 6 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 76,049 adverse event reports received by FDA, 0.4% of the database, from January 2004 to June 2026.

5,126 reports arrived in the 12 months to June 2026, close to the 5,584 of the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 87.7% of the class's reports are marked serious, 18.7% record death among the outcomes and 39.1% record hospitalisation, as reported.

Across the class the reactions recorded most often are hypotension (9.2%), toxicity to various agents (8.3%) and completed suicide (8.3%). The class median share shown beside each term is the middle value across the member drugs; it is the comparison used on every drug page in this class.

The members table is ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Drugs in the class

Drug	Name type	Reports	Latest 12 months	Marked serious	Top term recorded
Amlodipine	generic	52,216	4,324	93.2%	Completed suicide
NorvascAmlodipine besylate	brand	12,362	124	69%	Drug hypersensitivity
Diltiazem hydrochloride	generic	6,082	504	88.3%	Dyspnoea
Verapamil hydrochloride	generic	2,547	156	87.5%	Hypotension
CaduetAmlodipine and atorvastatin	brand	1,760	3	66%	Malaise
CardizemDiltiazem hydrochloride	brand	1,082	15	68.4%	Atrial fibrillation

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Reactions recorded across the class

share of class reports recording the termmedian drug in the class

Hypotensionlow blood pressure9.2%6,990
Toxicity to various agentspoisoning or toxic effect of one or more substances8.3%6,305
Completed suicidedeath by suicide8.3%6,297
Drug ineffectivethe medicine did not work as expected5.8%4,446
Dizzinesslight-headedness or unsteadiness5.8%4,391
Dyspnoeashortness of breath5.8%4,383
Drug interactionan interaction between medicines5.4%4,080
Fatiguetiredness4.9%3,707
Headachehead pain4.8%3,624
Falla fall4.8%3,619
Intentional overdosea deliberate overdose4.6%3,494
Hypertensionhigh blood pressure4.1%3,138
Nauseafeeling sick4.1%3,124
Malaisegeneral feeling of being unwell3.8%2,892
Painpain, site not specified3.8%2,878
Oedema peripheralswelling of the legs, ankles or hands3.7%2,795
Overdosea dose above the recommended amount3.6%2,764
Joint swellinga swollen joint3.6%2,739
Blood pressure increaseda raised blood pressure reading3.5%2,696
Vomitingbeing sick3.4%2,570
Acute kidney injurysudden loss of kidney function3.3%2,529
Coughcough3.1%2,363
Astheniaweakness or lack of energy3.1%2,330
Drug hypersensitivityan allergic-type reaction to a medicine3%2,294
Diarrhoealoose or frequent stools3%2,271

Solid bar: share of all class reports. Hollow bar: the median share across the 6 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death18.7%14,200

Life-threatening9.3%7,067

Hospitalisation (initial or prolonged)39.1%29,698

Disability4%3,065

Congenital anomaly0.7%523

Other serious57.2%43,467

Not serious12.3%9,354

Patient age

Under 20.3%254

2 to 110.6%431

12 to 171.5%1,146

18 to 448.3%6,276

45 to 6424.5%18,660

65 to 7417.2%13,064

75 and over20.1%15,254

Age not given27.6%20,964

Who reported

Physician31.2%23,728

Pharmacist9%6,875

Other health professional30.3%23,060

Lawyer0.2%115

Consumer or non-health professional25.1%19,061

Not given4.2%3,210

Grey bar: all 20,646,523 reports in the database. Outcome flags are as the reporter set them and are not verified by FDA.

Questions about Calcium channel blocker reports

Which drugs are in the Calcium channel blocker class on this site?

Amlodipine, Norvasc, Diltiazem hydrochloride, Verapamil hydrochloride, Caduet and Cardizem. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

76,049 reports through June 2026, 5,126 of them in the latest 12 months. A report listing two drugs of the class counts once for each.

What reactions are recorded most often?

hypotension (9.2%), toxicity to various agents (8.3%), completed suicide (8.3%), drug ineffective (5.8%) and dizziness (5.8%).

Can the members table be used to rank the drugs?

No. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." Drugs differ in how many people take them, in the conditions they treat, in time on the market and in how diligently reports are collected.

How do I report an adverse event?

Through FDA MedWatch (Form FDA 3500, or 1-800-FDA-1088) or to the manufacturer. See the guide on how to report.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A class is the Established Pharmacologic Class most often attached to a drug's reports by openFDA's label harmonisation, or from the NDC Directory where reports carry none. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.