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What is the most common side effect of Amlodipine?

In the pharmaceutical industry, Amlodipine is a dihydropyridine Calcium Channel Blocker (CCB). As a pharmacist and manufacturer, I classify Peripheral Edema (swelling of the ankles or feet) as its most common and clinically significant side effect, occurring in approximately 5% to 15% of patients, with a higher incidence in women.

At your WHO-GMP facility in Mumbai, this molecule is a high-volume essential medicine. Understanding the mechanism behind this side effect is crucial for providing technical support to your B2B clients and medical distributors.

The Most Common Side Effects

Side Effect Frequency Clinical Characterization
Peripheral Edema Very Common Fluid accumulation in the lower legs/ankles; dose-dependent.
Flushing Common Redness and warmth of the face and neck due to vasodilation.
Dizziness / Fatigue Common Often occurs during the initial phase of treatment as blood pressure drops.
Palpitations Common A sensation of a racing heart, often a reflex response to vasodilation.
Gingival Hyperplasia Rare Overgrowth of gum tissue around the teeth (requires long-term use).

Mechanism: Why the Ankles Swell

Amlodipine causes edema not through fluid retention (like salt), but through a “pressure imbalance” in the microscopic blood vessels.

  • Precapillary Vasodilation: Amlodipine selectively relaxes the smooth muscles of the arterioles (the vessels leading into the capillaries) but has little effect on the veins (the vessels leading out).

  • Capillary Hypertension: This creates a “bottleneck” effect where blood flows into the capillaries faster than it can leave. This increases the hydrostatic pressure inside the capillary.

  • Fluid Leakage: The high pressure forces fluid out of the blood vessel and into the surrounding tissue, resulting in the visible swelling of the ankles.

The Manufacturer’s Perspective: Technical & Export

From a production and B2B standpoint at your facility in Mumbai, here is how to position Amlodipine on your digital platforms:

  • The FDC Strategy (Amlodipine + Telmisartan/Lisinopril): As a pharmacist, you know that adding an ACE Inhibitor or ARB to Amlodipine can reduce the incidence of edema by dilating the veins as well. Promoting these Fixed-Dose Combinations on your marketplace is a high-value strategy for international trade.

    Photostability & Packaging: Amlodipine is highly sensitive to light. We utilize Alu-Alu blister packaging to ensure a 36-month shelf life. Highlighting this “Premium Packaging” is a major USP for export to Zone IVb tropical climates.

  • Dossier Readiness: Since Amlodipine is a first-line treatment for hypertension globally, we maintain full CTD/eCTD Dossiers to help your firm bid for national health tenders in Southeast Asia, Africa, and the Middle East.

  • Bioequivalence: Emphasize that your Amlodipine Besylate tablets achieve bioequivalence with the innovator (Norvasc), ensuring that B2B buyers are getting international-grade efficacy.

Amlodipine Tablet