Pharmacologic class (EPC) · 6 drug pages

Dihydropyridine calcium channel blocker: adverse event reports filed with FDA

26,910 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.

26,910
reports across the class: 0.1% of all reports; 1,962
reports, 12 months to June 2026: 2,161 in the 12 months before; 82.3%
marked serious by the reporter: 57.4% across all reports; 6
drugs with a page: brand and generic names counted separately

Dihydropyridine 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 26,910 adverse event reports received by FDA, 0.1% of the database, from January 2004 to June 2026.

1,962 reports arrived in the 12 months to June 2026, close to the 2,161 of the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 82.3% of the class's reports are marked serious, 11.2% record death among the outcomes and 38% record hospitalisation, as reported.

Across the class the reactions recorded most often are drug ineffective (8.7%), dyspnoea (8.4%) and hypotension (8%). 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 besylate	generic	11,899	1,002	82%	Dyspnoea
Nifedipine	generic	10,119	644	79.8%	Drug ineffective
Felodipine	generic	2,049	145	91.4%	Fatigue
Nicardipine hydrochloride	generic	1,082	91	97.4%	Premature baby
Nicardipine	generic	1,072	77	96.7%	Foetal exposure during pregnancy
ProcardiaNifedipine	brand	689	3	52%	Headache

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

Drug ineffectivethe medicine did not work as expected8.7%2,349
Dyspnoeashortness of breath8.4%2,259
Hypotensionlow blood pressure8%2,166
Vomitingbeing sick6.4%1,732
Painpain, site not specified6.4%1,728
Headachehead pain6%1,603
Fatiguetiredness5.9%1,585
Off label useused for a purpose or in a way not on the label5.9%1,584
Dizzinesslight-headedness or unsteadiness5.9%1,583
Drug interactionan interaction between medicines5.8%1,573
Toxicity to various agentspoisoning or toxic effect of one or more substances5.7%1,537
Malaisegeneral feeling of being unwell5.7%1,523
Nauseafeeling sick5.4%1,465
Drug hypersensitivityan allergic-type reaction to a medicine5.1%1,373
Foetal exposure during pregnancythe unborn baby was exposed to the medicine4.5%1,210
Hypertensionhigh blood pressure4.4%1,187
Asthmaasthma4.4%1,186
Premature babya baby born early4.2%1,118
Pneumonialung infection4.1%1,105
Completed suicidedeath by suicide4.1%1,103
Falla fall3.9%1,039
Palpitationsawareness of the heartbeat3.8%1,024
Chest painchest pain3.8%1,015
Diarrhoealoose or frequent stools3.7%999
Blood pressure increaseda raised blood pressure reading3.6%979

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

Death11.2%3,026

Life-threatening9.4%2,531

Hospitalisation (initial or prolonged)38%10,239

Disability3.5%938

Congenital anomaly1.4%381

Other serious57.2%15,380

Not serious17.7%4,760

Patient age

Under 21.1%295

2 to 111%267

12 to 171.2%336

18 to 4412.4%3,327

45 to 6420.7%5,559

65 to 7415.8%4,255

75 and over17.4%4,673

Age not given30.5%8,198

Who reported

Physician25.3%6,805

Pharmacist7.6%2,052

Other health professional36.4%9,789

Lawyer0.1%34

Consumer or non-health professional25.9%6,979

Not given4.6%1,251

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 Dihydropyridine calcium channel blocker reports

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

Amlodipine besylate, Nifedipine, Felodipine, Nicardipine hydrochloride, Nicardipine and Procardia. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

26,910 reports through June 2026, 1,962 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?

drug ineffective (8.7%), dyspnoea (8.4%), hypotension (8%), vomiting (6.4%) and pain (6.4%).

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.