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Norvasc (amlodipine)
Long-acting dihydropyridine calcium channel blocker that relaxes vascular smooth muscle, reducing blood pressure and myocardial oxygen demand.
Amlodipine (Norvasc) is a long-acting calcium channel blocker developed by Pfizer and approved in 1992. Its 30-50 hour half-life provides smooth 24-hour blood pressure control. Now available generically, it is one of the most prescribed antihypertensives worldwide.
At a glance
| Generic name | amlodipine |
|---|---|
| Also known as | Norvasc |
| Sponsor | Pfizer Inc. |
| Drug class | Calcium channel blocker (dihydropyridine) |
| Target | Aldehyde oxidase, Voltage-dependent calcium channel gamma-1 subunit, 5-hydroxytryptamine receptor 6 |
| Modality | Small molecule |
| Therapeutic area | Neuroscience |
| Phase | FDA-approved |
| First approval | 1992-07-31 (United States) |
Mechanism of action
Amlodipine is a third-generation dihydropyridine calcium channel blocker with an exceptionally long half-life (30-50 hours), allowing once-daily dosing with smooth 24-hour blood pressure control. It selectively relaxes vascular smooth muscle with minimal cardiac depressant effects. Developed by Pfizer, it was one of the first cardiovascular drugs to achieve blockbuster status.
Approved indications
- Angina pectoris
- Cerebrovascular accident
- Hypertensive disorder
- Myocardial Infarction Prevention
- Primary Prevention of Coronary Heart Disease
- Prinzmetal angina
Common side effects
- Edema (amlodipine monotherapy)
- Cough
- Headache
- Edema (amlodipine/benazepril combination)
- Dizziness
Serious adverse events
- Angioedema
- Neutropenia
Key clinical trials
- Clinical Trial to Assess the Pharmacokinetic Characteristics of Lodivixx Tab. 5/160mg in Healthy Male Subjects (Phase 1)
- Comparison of Phosphodiesterase-5 Inhibitor and Calcium Channel Inhibitor for the Treatment of Secondary Raynaud Phenomenon, Double Blind, Randomized, Cross-over Trial (Phase 2)
- A Randomized, Open-label, Multiple Doses, Crossover Study to Evaluate a Pharmacokinetic Drug Interaction and Safety of Amlodipine Between Free Combination of Amlodipine and Candesartan and Amlodipine (Phase 1)
- The Objective of This Study Was to Compare the Rate and Extent of Absorption of Ranbaxy Amlodipine 10 mg Tablet to That of Norvasc® 10 mg Tablet After a Single, One Tablet Dose in Fed State Subjects. (NA)
- A Single Dose, Two-Period, Two-Treatment, 2-Way Crossover Bioequivalency Study of 10 mg Amlodipine Besylate Tablets Under Fed Conditions (NA)
- Effects of Amlodipine/Benazepril in Reducing Left Ventricular Hypertrophy in Patients With High Risk Hypertension (Phase 4)
- An Open-label Randomized, Single Dose, Two Way Crossover Oral Bioequivalence Study of Amlodipine Besylate/Benazepril HCl Capsules of Dr. Reddy's With Lotrel® Capsules of Novartis in Human Subjects Und (Phase 1)
- Effect of Antihypertensive Agents on Diastolic Function in Patients With Sleep Apnea: Protocol for a Randomized Controlled Trial (Phase 3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Norvasc CI brief — competitive landscape report
- Norvasc updates RSS · CI watch RSS
- Pfizer Inc. portfolio CI