Altace Side Effects

Generic name: ramipril

Note: This document contains side effect information about ramipril. Some of the dosage forms listed on this page may not apply to the brand name Altace.

Some side effects of Altace may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to ramipril: oral capsule, oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking ramipril (the active ingredient contained in Altace) hives; severe stomach pain; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking ramipril and call your doctor at once if you have a serious side effect such as:

• feeling like you might pass out;

• high potassium level (slow heart rate, weak pulse, muscle weakness, tingly feeling;

• dry mouth, thirst, confusion, swelling, and urinating less than usual or not at all;

• pale skin, dark colored urine, easy bruising or bleeding;

• jaundice (yellowing of the skin or eyes); or

• fever, chills, body aches, flu symptoms, sores in your mouth and throat.

Less serious side effects of ramipril may include:

• cough;

• tired feeling, headache;

• dizziness, spinning sensation; or

• nausea, vomiting.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to ramipril: oral capsule, oral tablet

General

Ramipril is generally well-tolerated. Most side effects are reported as often in patients taking placebo. Less than 3% of patients discontinue ramipril (the active ingredient contained in Altace) due to an adverse drug event.

Nervous system

Nervous system side effects include headache, dizziness, and lightheadedness in 2% to 5% of patients. Asthenia and fatigue occur in 2% of patients.

Cardiovascular

Cardiovascular problems are limited mainly to hypotension in 0.5% of patients. Angioneurotic edema is reported in 0.1% to 0.5% of patients, and may be fatal.

The exact mechanism by which ACE inhibitors produce angioedema is not well known, but is believed to involve stimulation of the kallikrein-kinin system, particularly in patients who are genetically or environmentally predisposed.

Gastrointestinal

Rare cases of abdominal pain associated with elevated enzymes suggestive of pancreatitis are reported.

Gastrointestinal complaints of nausea or dyspepsia are reported in approximately 1% of patients. Rare problems include general abdominal pain or fullness, dry mouth, dysphasia, constipation, diarrhea, gastroenteritis, anorexia, vomiting, increased salivation, and dysgeusia.

Respiratory

Respiratory side effects are limited to an idiosyncratic and reversible cough in approximately 3% of patients.

Several agents have been studied for treating cough with ACE inhibitors. No long term trials exist to allow a definitive treatment option. Cromolyn has the most data showing some benefit. Other agents studied include baclofen, theophylline, sulindac, and benzonatate.

Renal

In one study of 13 patients with congestive heart failure, mean creatinine clearance increased during ramipril (the active ingredient contained in Altace) therapy.

Renal insufficiency occurs in approximately 1% to 2% of patients and is usually transient. In general, ACE inhibitor-induced renal insufficiency is much more likely in sodium- or intravascular volume-depleted patients, or in those patients on concomitant diuretic therapy.

Metabolic

Metabolic changes include significant increases in serum potassium in 1% to 2% of patients. Extremely rare cases of hyponatremia have been associated with the use of ramipril (the active ingredient contained in Altace) (and other ACE inhibitors) in the elderly.

Ramipril has not been associated with deleterious changes in blood glucose or serum lipids in patients with diabetes mellitus.

Increases in serum potassium are associated with ACE inhibitors because they decrease aldosterone secretion, which usually promotes renal potassium excretion.

The mechanism of hyponatremia (rare) is unknown. Hyponatremia associated with ACE inhibitors presents like SIADH and may be due to inhibition of bradykinin metabolism or direct stimulation of ADH secretion by angiotensin II in the central nervous system (angiotensin I accumulates during ACE inhibitor therapy and crosses the blood-brain barrier).

Ramipril, like other ACE inhibitors does not appear to exert a significant effect on plasma glucose, insulin, or C-peptide levels.

Genitourinary

Genitourinary complaints are limited to impotence in 0.4% of patients.

Hypersensitivity

Hypersensitivity reactions to angiotensin converting enzyme (ACE) inhibitors may be life threatening. Angioedema of the face, extremities, lips, tongue, glottis and/or pharynx have been reported rarely in patients receiving ACE inhibitors. In addition, intestinal angioedema has been reported in patients treated with ACE inhibitors. It is recommended that any patient with dyspnea, dysphagia, or significant facial angioedema stop therapy immediately and avoid ACE inhibitor therapy in general.

Dermatitis, pruritus, and photosensitivity have also been reported.

Patients with intestinal angioedema generally present with abdominal pain (with or without nausea or vomiting) and in some cases there was no prior history of facial angioedema, and C-1 esterase levels were normal. These symptoms resolve after stopping the ACE inhibitor.

Hematologic

Hematologic side effects including agranulocytosis have been associated with ACE inhibitors including ramipril (the active ingredient contained in Altace)

ACE inhibitors have been used to treat post renal transplant erythrocytosis. Data have shown that they may decrease circulating erythropoietin levels in these patients.

Musculoskeletal

Musculoskeletal pains--both arthralgias and myalgias--have rarely been associated with the use of some ACE inhibitors, including ramipril (the active ingredient contained in Altace)

Dermatologic

Dermatologic side effects are typically the result of hypersensitivity reactions. Rare cases of pemphigus, including lichen planus pemphigoides, have been associated with the use of ramipril (the active ingredient contained in Altace) and other ACE inhibitors. In addition, Stevens-Johnson syndrome has been associated with ramipril therapy.

Drug-induced pemphigus has also been associated with a related drug, captopril. The mechanism remains unknown but drugs containing a thiol group may be involved as they are able to produce acantholysis of epidermal cells in vitro. Drugs containing an amide group have also been associated with pemphigus. These include enalapril which also induced acantholysis in vitro. (Four cases of enalapril-induced pemphigus have been reported.) Spontaneous remission of the skin lesions after drug withdrawal is less common with drugs containing the amide group compared with drugs containing the thiol group (15% vs. 50%).

Hepatic

Hepatic side effects including hepatic failure, hepatitis, jaundice and pancreatitis have been reported rarely.

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