In the pharmaceutical industry, Enalapril Maleate is a cornerstone ACE (Angiotensin-Converting Enzyme) Inhibitor. As a pharmacist and manufacturer, I classify this as a “systemic vasodilator” with significant cardiovascular benefits.
However, its interference with the Renin-Angiotensin-Aldosterone System (RAAS) and the breakdown of kinins leads to a specific set of major side effects that every clinician and manufacturer must monitor.
Major Clinical Side Effects
| Category | Side Effect | Clinical Context |
| Respiratory | Persistent Dry Cough | Occurs in 5–20% of patients; caused by the accumulation of bradykinin in the lungs. |
| Immune | Angioedema | Severe swelling of the face, lips, or tongue. A medical emergency more common in certain ethnic groups. |
| Renal | Hyperkalemia | Elevated potassium ($K^+$) levels due to decreased aldosterone secretion. |
| Cardiovascular | First-Dose Hypotension | A sudden drop in blood pressure, especially in patients already on diuretics. |
| Renal Function | Acute Renal Failure | Specifically a risk in patients with bilateral renal artery stenosis. |
Mechanism: Why the Cough and Swelling?
The most famous side effect of Enalapril—the “ACE-I cough”—is directly linked to its mechanism of action.
ACE Blockade: Enalapril prevents the conversion of Angiotensin I to Angiotensin II (a vasoconstrictor).
Bradykinin Accumulation: The ACE enzyme is also responsible for breaking down Bradykinin (an inflammatory peptide).
Irritation: When ACE is inhibited, Bradykinin levels rise. In the lungs, this triggers the cough reflex. In the skin/mucosa, it can trigger the localized swelling known as Angioedema.
The Manufacturer’s Perspective: Technical & Export
From a production and B2B standpoint at your WHO-GMP facility in Mumbai, the “Maleate” salt requires specific handling:
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Stability & Cyclization: Enalapril Maleate is highly sensitive to moisture and can degrade into Enalaprilat or undergo “cyclization” into diketopiperazine (DKP). At our facility, we utilize Alu-Alu blister packaging to maintain a 36-month shelf life. Highlighting this stability is a major USP for export to humid Zone IVb climates.
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The “Maleate” Choice: We use the Maleate salt because of its superior stability compared to the base. When promoting this on your digital platforms, emphasize your adherence to BP/USP/IP purity standards to reassure B2B buyers.
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Product Information Leaflet (PIL): As a pharmacist, you must ensure your PILs include a “Black Box” warning regarding fetal toxicity. ACE inhibitors should never be used during pregnancy as they cause severe fetal skull hypoplasia and renal failure.
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Dossier Support: This is a high-volume product for national health tenders. We provide full CTD/eCTD Dossiers to support your firm in bidding for government contracts across Africa and Southeast Asia.