Ramipril Recall

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Side Effects & Adverse Reactions

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Legal Issues

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FDA Safety Alerts

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Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.


1.1 Hypertension

Ramipril capsules, USP 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 this drug.

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).

Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.

Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.

Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.

Ramipril capsules, USP may be used alone or in combination with thiazide diuretics.

1.3 Heart Failure Post-Myocardial Infarction

Ramipril capsules, USP are indicated in stable patients who have demonstrated clinical signs of congestive heart failure within the first few days after sustaining acute myocardial infarction. Administration of ramipril capsules to such patients has been shown to decrease the risk of death (principally cardiovascular death) and to decrease the risks of failure-related hospitalization and progression to severe/resistant heart failure [see CLINICAL STUDIES (14.3)].


There is currently no drug history available for this drug.

Other Information

Ramipril is a 2-aza-bicyclo [3.3.0]-octane-3-carboxylic acid derivative. Ramipril, USP is a white to almost white crystalline powder. It is freely soluble in methanol and sparingly soluble in water. Ramipril melts between 105°C and 112° C.

Ramipril’s chemical name is (2S, 3aS, 6aS)-1[(S)-N-[(S)-1-Carboxy-3-phenylpropyl]alanyl] octahydrocyclopenta [b]pyrrole-2-carboxylic acid, 1 -ethyl ester; its structural formula is:

Chemical structure

Its molecular formula is C23H32N2O5, and its molecular weight is 416.5.

Ramiprilat, the diacid metabolite of ramipril, is a non-sulfhydryl angiotensin converting enzyme inhibitor. Ramipril is converted to ramiprilat by hepatic cleavage of the ester group.

Each ramipril capsule, USP intended for oral administration contains 1.25 mg or 2.5 mg or 5 mg or 10 mg of ramipril, USP. In addition, each capsule contains the following inactive ingredients: gelatin, pregelatinized starch and titanium dioxide. Additionally each 1.25 mg capsule shell contains: FD&C red # 40, FD&C yellow # 5 and FD&C yellow # 6, 2.5 mg capsule shell contains: D&C yellow # 10 and FD&C red # 40, 5 mg capsule shell contains: FD&C blue # 1, FD&C red # 40 and FD&C yellow # 6 and 10 mg capsule shell contains:, D&C red # 28, D&C yellow # 10 and FD&C blue # 1. The capsule is printed with black pharmaceutical ink which contains black iron oxide as a coloring agent.

Ramipril Manufacturers

  • Bluepoint Laboratories
    Ramipril Capsule [Bluepoint Laboratories]
  • Apotex Corp.
    Ramipril Capsule [Apotex Corp.]
  • Blenheim Pharmacal, Inc.
    Ramipril Capsule [Blenheim Pharmacal, Inc.]
  • Northwind Pharmaceuticals
    Ramipril Tablet [Northwind Pharmaceuticals]
  • Direct Rx
    Ramipril Capsule [Direct Rx]
  • Invagen Pharmaceuticals, Inc
    Ramipril (Ramipril) Capsule [Invagen Pharmaceuticals, Inc]
  • Rebel Distributors Corp
    Ramipril Capsule [Rebel Distributors Corp]
  • Cadila Healthcare Limited
    Ramipril Capsule [Cadila Healthcare Limited]
  • Atlantic Biologicals Corps
    Ramipril Capsule [Atlantic Biologicals Corps]
  • Remedyrepack Inc.
    Ramipril Capsule [Remedyrepack Inc. ]
  • Camber Pharmaceuticals
    Ramipril Capsule [Camber Pharmaceuticals]
  • Exelan Pharmaceuticals, Inc.
    Ramipril Capsule [Exelan Pharmaceuticals, Inc.]
  • Golden State Medical Supply, Inc.
    Ramipril Capsule [Golden State Medical Supply, Inc.]
  • Pd-rx Pharmaceuticals, Inc.
    Ramipril Capsule [Pd-rx Pharmaceuticals, Inc.]
  • Dispensing Solutions, Inc.
    Ramipril Capsule [Dispensing Solutions, Inc.]
  • Bryant Ranch Prepack
    Ramipril Capsule [Bryant Ranch Prepack]
  • Bryant Ranch Prepack
    Ramipril Capsule [Bryant Ranch Prepack]
  • Dr. Reddy’s Laboratories Limited
    Ramipril Capsule [Dr. Reddy’s Laboratories Limited]
  • Physicians Total Care, Inc.
    Ramipril Capsule [Physicians Total Care, Inc.]
  • Lake Erie Medical Dba Quality Care Products Llc
    Ramipril Capsule [Lake Erie Medical Dba Quality Care Products Llc]
  • Cobalt Laboratories
    Ramipril Capsule [Cobalt Laboratories]
  • Apotex Corp.
    Ramipril Capsule [Apotex Corp.]
  • Roxane Laboratories, Inc
    Ramipril Capsule [Roxane Laboratories, Inc]
  • Pd-rx Pharmaceuticals, Inc.
    Ramipril Capsule [Pd-rx Pharmaceuticals, Inc.]
  • American Health Packaging
    Ramipril Capsule [American Health Packaging]
  • Aidarex Pharmaceuticals Llc
    Ramipril Capsule [Aidarex Pharmaceuticals Llc]
  • Unit Dose Services
    Ramipril Capsule [Unit Dose Services]
  • Zydus Pharmaceuticals (Usa) Inc.
    Ramipril Capsule [Zydus Pharmaceuticals (Usa) Inc.]
  • Northwind Pharmaceuticals
    Ramipril Capsule [Northwind Pharmaceuticals]
  • Teva Pharmaceuticals Usa Inc
    Ramipril Capsule [Teva Pharmaceuticals Usa Inc]
  • Bluepoint Laboratories
    Ramipril Capsule [Bluepoint Laboratories]
  • Proficient Rx Lp
    Ramipril Capsule [Proficient Rx Lp]
  • Aurobindo Pharma Limited
    Ramipril Capsule [Aurobindo Pharma Limited]
  • Accord Healthcare Inc.
    Ramipril Capsule [Accord Healthcare Inc.]
  • Carilion Materials Management
    Ramipril Capsule [Carilion Materials Management]
  • Cardinal Health
    Ramipril Capsule [Cardinal Health]
  • Lupin Pharmaceuticals, Inc.
    Ramipril Capsule [Lupin Pharmaceuticals, Inc.]
  • Medsource Pharmaceuticals
    Ramipril Capsule [Medsource Pharmaceuticals]
  • Directrx
    Ramipril Capsule [Directrx]

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