Ramipril is an angiotensin converting enzyme inhibitor sold in the U.S. under 2 brand and generic names, for diabetic nephropathies, heart failure and hypertension. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Altace (application NDA019901). Other ramipril products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Hypertension: Initial dose is 2.5 mg to 20 mg once daily. Adjust dosage according to blood pressure response after 2 to 4 weeks of treatment. The usual maintenance dose following titration is 2.5 mg to 20 mg daily as a single dose or equally divided doses ( 2.1 ). Reduction in the risk of myocardial infarction, stroke, or death from cardiovascular causes: 2.5 mg once daily for 1 week, 5 mg once daily for 3 weeks, and increased as tolerated to a maintenance dose of 10 mg once daily (2.2). Heart failure post-myocardial infarction: Starting dose of 2.5 mg twice daily. If patient becomes hypotensive at this dose, decrease dosage to 1.25 mg twice daily. Increase dose as tolerated toward a target dose of 5 mg twice daily, with dosage increases about 3 weeks apart (2.3). Dosage adjustment: See respective sections pertaining to dosage adjustment in special situations ( 2.5 ). 2.1 Hypertension The recommended initial dose for patients not receiving a diuretic is 2.5 mg once a day. Adjust dose according to blood pressure response. The usual maintenance dosage range is 2.5 mg to 20 mg per day administered as a single dose or in two equally divided doses. In some patients treated once daily, the antihypertensive effect may diminish toward the end of the dosing interval. In such patients, consider an increase in dosage or twice daily administration. If blood pressure is not controlled with…
The most common adverse reactions in patients with hypertension included headache, dizziness, fatigue, and cough ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact CorePharma LLC. at 732-419-8800 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Hypertension Ramipril has been evaluated for safety in over 4000 patients with hypertension; of these, 1230 patients were studied in U.S. controlled trials, and 1107 were studied in foreign controlled trials. Almost 700 of these patients were treated for at least one year. The overall incidence of reported adverse events was similar in ramipril and placebo patients. The most frequent clinical side effects (possibly or probably related to study drug) reported by patients receiving ramipril in placebo-controlled trials were: headache (5.4%), dizziness (2.2%), and fatigue or asthenia (2.0%), but only the last one was more common in ramipril patients than in patients given placebo. Generally the side effects were mild and transient, and there was no relation to total dosage within the range of 1.25 mg - 20 mg. Discontinuation of therapy…
Potassium-rich foods & salt substitutes
Don't use potassium-based salt substitutes unless your clinician approves, and ask before taking potassium supplements. Your clinician may check your potassium level with blood tests.
Lisinopril (an ACE inhibitor) — MedlinePlus (U.S. National Library of Medicine) ↗Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Typical price | |
|---|---|---|---|---|---|---|---|
| 1 | Not yet rated | Prescription | Tablet | Generic | $2 | View → | |
| 2 |
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
| Imprint | Strength | Colour | Shape | Maker |
|---|---|---|---|---|
| LUPIN;RAMIPRIL;2;5;mg | 2.5 mg | orange | capsule | — |
| LUPIN;RAMIPRIL;5;mg | 5 mg | red | capsule | — |
| LUPIN;RAMIPRIL;10;mg | 10 mg | blue | capsule | — |
| LUPIN;RAMIPRIL;1;25;mg | 1.25 mg | yellow | capsule | — |
| ZA;44;2;5mg | 2.5 mg | white, orange | capsule | — |
| ZA;45;5mg |
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
Ramipril Capsules USP 5 mg
CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
Lupin Pharmaceuticals Inc. · Oct 23, 2024
Ramipril Capsules USP 2.5 mg
CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
Lupin Pharmaceuticals Inc. · Oct 23, 2024
Ramipril Capsules USP 10 mg
CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
Lupin Pharmaceuticals Inc. · Oct 23, 2024
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Ramipril capsules is contraindicated in patients who are hypersensitive to this product or any other ACE inhibitor (e.g., a patient who has experienced angioedema during therapy with any other ACE inhibitor). Ramipril capsules are contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). Do not administer ramipril within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor [see Warnings and Precautions (5.1) ] . Do not co-administer ramipril capsules with aliskiren: in patients with diabetes Angioedema related to previous treatment with an ACE inhibitor, or a history of hereditary or idiopathic angioedema (4). Ramipril Capsules are contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). Do not administer ramipril capsules within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor (4). Do not co-administer aliskiren with ramipril capsules in patients with diabetes (4) .
Diuretics: Possibility of excessive hypotension ( 7.1 ). Lithium: Use with caution (7.4). Gold: Nitritoid reactions have been reported (7.5). NSAIDS use may lead to increased risk of renal impairment and loss of antihypertensive effect (7.6). mTOR inhibitor or neprilysin inhibitor use may increase angioedema risk (7.7). 7.1 Diuretics Patients on diuretics, especially those in whom diuretic therapy was recently instituted, may occasionally experience an excessive reduction of blood pressure after initiation of therapy with ramipril. The possibility of hypotensive effects with ramipril can be minimized by either decreasing or discontinuing the diuretic or increasing the salt intake prior to initiation of treatment with ramipril. If this is not possible, reduce the starting dose [ see Dosage and Administration ( 2 ) ]. 7.2 Agents Increasing Serum Potassium Coadministration of ramipril with other drugs that raise serum potassium levels may result in hyperkalemia. Monitor serum potassium in such patients. 7.3 Other Agents Affecting RAS In general, avoid combined use of RAS inhibitors. [see Warnings and Precautions (5.7) ] . Do not co-administer aliskiren with Ramipril in patients with diabetes [see Contraindications (4) ] . 7.4 Lithium Increased serum lithium levels and symptoms of lithium toxicity have been reported in patients receiving ACE inhibitors during therapy with lithium;…
| Prescription |
| Solution |
| Generic |
| $2 |
| View → |
| 5 mg |
| white, red |
| capsule |
| — |
| ZA;46;10mg | 10 mg | white, blue | capsule | — |
|---|
| 54;328 | 1.25 mg | yellow | capsule | — |
|---|
| 54;794 | 2.5 mg | orange | capsule | — |
|---|
| 54;145 | 5 mg | red | capsule | — |
|---|
| 54;602 | 10 mg | blue | capsule | — |
|---|
| D;07 | 5 mg | red | capsule | — |
|---|