Amlodipine
Dihydropyridine Derivatives
Sold as Dafiro · Copalia · Exforge · Imprida · Copalia HCT
- Drug class
- Dihydropyridine Derivatives
- Availability
- Prescription only
- Routes
- Oral
- Markets covered
- 4
- Products on record
- 268
- FDA reports (12 mo)
- 22,241
Overview
Amlodipine is an active pharmaceutical ingredient in the Dihydropyridine Derivatives group (C08CA). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| GB United Kingdom | MHRA | 130 | May 29, 2026 |
| CA Canada | Health Canada | 109 | March 2, 2026 |
| US United States | FDA | 24 | April 28, 2026 |
| EU European Union | EMA | 5 | February 6, 2026 |
GBUnited Kingdom· MHRA
130 products
Uses
Treatment of hypertension in adults. Ramipril/Amlodipine is indicated as substitution therapy of patients with blood pressure adequately controlled with ramipril and amlodipine given concurrently at the same dose level as in the combination, but as separate tablets.
How to take
CACanada· Health Canada
109 products
Uses
NORVASC (amlodipine besylate tablets) is indicated for: • Hypertension NORVASC is indicated in the treatment of mild to moderate essential hypertension. Combination of NORVASC with a diuretic, a beta-blocking agent, or an angiotensin converting enzyme inhibitor has been found to be compatible and showed additive antihypertensive effect.
• Chronic Stable Angina NORVASC is indicated for the management of chronic stable angina (effort-associated angina) in patients who remain symptomatic despite adequate doses of beta-blockers and/or organic nitrates or who cannot tolerate those agents.
NORVASC may be tried in combination with beta-blockers in chronic stable angina in patients with normal ventricular function. When such concomitant therapy is introduced, care must be taken to monitor blood pressure closely since hypotension can occur from the combined effects of the drugs.
1 Pediatrics Pediatrics (6 – 17 years of age): Based on the data submitted and reviewed by Health Canada, the safety and efficacy of NORVASC in pediatric patients has been established. 2 Pharmacodynamics). 3 Pediatrics). 2 Recommended Dose and Dosage Adjustment).
USUnited States· FDA
24 products
Uses
1 ) о Amlodipine besylate tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.
1 Hypertension Amlodipine besylate tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.
These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including amlodipine besylate. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake.
Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).
EUEuropean Union· EMA
5 products
Uses
Treatment of essential hypertension as substitution therapy in adult patients whose blood pressure is adequately controlled on the combination of amlodipine, valsartan and hydrochlorothiazide (HCT), taken either as three single-component formulations or as a dual-component and a single-component formulation.
How to take
Drug interactions
Known interactions involving Amlodipine. Select one for details. This list is informational and not a complete interaction checker.
Showing 240 of 600. Type above to find a specific drug.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]MHRA (UK) · PL306840352 · revised August 8, 2025
- [2]Health Canada (DPD) · 00878928 · revised March 22, 2025
- [3]FDA DailyMed · 003dd1ec-16f8-4f… · revised April 20, 2026 [PDF]
- [4]European Medicines Agency · EMEA/H/C/001159 · revised February 6, 2026
- [5]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.