Altace Side Effects

Generic Name: ramipril

Please note - some side effects for Altace may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Altace - for the Consumer

Altace

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Altace:

Cough; dizziness; headache; tiredness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the hands, eyes, mouth, face, lips, or tongue; hoarseness); chest pain; dark urine; decreased urination; difficulty swallowing; fainting; infection (eg, fever, chills, persistent sore throat); irregular heartbeat; seizures; stomach pain (with or without nausea or vomiting); symptoms of low blood pressure (eg, fainting, severe dizziness, lightheadedness); yellowing of the skin or eyes.

Altace Capsules

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Altace Capsules:

Cough; dizziness; headache; tiredness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the hands, eyes, mouth, face, lips, or tongue; hoarseness); chest pain; dark urine; decreased urination; difficulty swallowing; fainting; infection (eg, fever, chills, persistent sore throat); irregular heartbeat; seizures; stomach pain (with or without nausea or vomiting); symptoms of low blood pressure (eg, fainting, severe dizziness, lightheadedness); yellowing of the skin or eyes.

Altace Side Effects - for the Professional

Altace

Hypertension

Altace has been evaluated for safety in over 4,000 patients with hypertension; of these, 1,230 patients were studied in US controlled trials, and 1,107 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 Altace and placebo patients. The most frequent clinical side effects (possibly or probably related to study drug) reported by patients receiving Altace in US placebo-controlled trials were: headache (5.4%), “dizziness” (2.2%) and fatigue or asthenia (2.0%), but only the last was more common in Altace 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 to 20 mg. Discontinuation of therapy because of a side effect was required in approximately 3% of US patients treated with Altace. The most common reasons for discontinuation were: cough (1.0%), “dizziness” (0.5%), and impotence (0.4%).

Of observed side effects considered possibly or probably related to study drug that occurred in US placebo-controlled trials in more than 1% of patients treated with Altace, only asthenia (fatigue) was more common on Altace than placebo (2% vs. 1%).

In placebo-controlled trials, there was also an excess of upper respiratory infection and flu syndrome in the ramipril group, not attributed at that time to ramipril. As these studies were carried out before the relationship of cough to ACE inhibitors was recognized, some of these events may represent ramipril-induced cough. In a later 1-year study, increased cough was seen in almost 12% of ramipril patients, with about 4% of patients requiring discontinuation of treatment.

Heart Failure Post Myocardial Infarction

Adverse reactions (except laboratory abnormalities) considered possibly/probably related to study drug that occurred in more than one percent of patients and more frequently on ramipril are shown below. The incidences represent the experiences from the AIRE study. The follow-up time was between 6 and 46 months for this study.

Percentage of Patients with Adverse Events Possibly/ Probably Related to Study Drug

Placebo-Controlled (AIRE) Mortality Study

HOPE Study:

Safety data in the HOPE trial were collected as reasons for discontinuation or temporary interruption of treatment. The incidence of cough was similar to that seen in the AIRE trial. The rate of angioedema was the same as in previous clinical trials.

Other adverse experiences reported in controlled clinical trials (in less than 1% of ramipril patients), or rarer events seen in postmarketing experience, include the following (in some, a causal relationship to drug use is uncertain):

Body As a Whole: Anaphylactoid reactions.

Cardiovascular: Symptomatic hypotension (reported in 0.5% of patients in US trials), syncope and palpitations.

Hematologic: Pancytopenia, hemolytic anemia and thrombocytopenia.

Renal: Some hypertensive patients with no apparent pre-existing renal disease have developed minor, usually transient, increases in blood urea nitrogen and serum creatinine when taking Altace, particularly when Altace was given concomitantly with a diuretic. Acute renal failure.

Angioneurotic Edema: Angioneurotic edema has been reported in 0.3% of patients in US clinical trials.

Gastrointestinal: Hepatic failure, hepatitis, jaundice, pancreatitis, abdominal pain (sometimes with enzyme changes suggesting pancreatitis), anorexia, constipation, diarrhea, dry mouth, dyspepsia, dysphagia, gastroenteritis, increased salivation and taste disturbance.

Dermatologic: Apparent hypersensitivity reactions (manifested by urticaria, pruritus, or rash, with or without fever), photosensitivity, purpura, onycholysis, pemphigus, pemphigoid, erythema multiforme, toxic epidermal necrolysis, and Stevens-Johnson syndrome.

Neurologic and Psychiatric: Anxiety, amnesia, convulsions, depression, hearing loss, insomnia, nervousness, neuralgia, neuropathy, paresthesia, somnolence, tinnitus, tremor, vertigo, and vision disturbances.

Miscellaneous: As with other ACE inhibitors, a symptom complex has been reported which may include a positive ANA, an elevated erythrocyte sedimentation rate, arthralgia/arthritis, myalgia, fever, vasculitis, eosinophilia, photosensitivity, rash and other dermatologic manifestations. Additionally, as with other ACE inhibitors, eosinophilic pneumonitis has been reported.

Fetal/Neonatal Morbidity and Mortality. See WARNINGS : Fetal/Neonatal Morbidity and Mortality .

Other: arthralgia, arthritis, dyspnea, edema, epistaxis, impotence, increased sweating, malaise, myalgia, and weight gain.

Post-Marketing Experience: In addition to adverse events reported from clinical trials, there have been rare reports of hypoglycemia reported during Altace therapy when given to patients concomitantly taking oral hypoglycemic agents or insulin. The causal relationship is unknown.

Clinical Laboratory Test Findings:

Creatinine and Blood Urea Nitrogen: Increases in creatinine levels occurred in 1.2% of patients receiving Altace alone, and in 1.5% of patients receiving Altace and a diuretic. Increases in blood urea nitrogen levels occurred in 0.5% of patients receiving Altace alone and in 3% of patients receiving Altace with a diuretic. None of these increases required discontinuation of treatment. Increases in these laboratory values are more likely to occur in patients with renal insufficiency or those pretreated with a diuretic and, based on experience with other ACE inhibitors, would be expected to be especially likely in patients with renal artery stenosis. Since ramipril decreases aldosterone secretion, elevation of serum potassium can occur. Potassium supplements and potassium-sparing diuretics should be given with caution, and the patient’s serum potassium should be monitored frequently.

Hemoglobin and Hematocrit: Decreases in hemoglobin or hematocrit (a low value and a decrease of 5 g/dl or 5% respectively) were rare, occurring in 0.4% of patients receiving Altace alone and in 1.5% of patients receiving Altace plus a diuretic. No US patients discontinued treatment because of decreases in hemoglobin or hematocrit.

Other (causal relationships unknown): Clinically important changes in standard laboratory tests were rarely associated with Altace administration. Elevations of liver enzymes, serum bilirubin, uric acid, and blood glucose have been reported, as have cases of hyponatremia and scattered incidents of leukopenia, eosinophilia, and proteinuria. In US trials, less than 0.2% of patients discontinued treatment for laboratory abnormalities; all of these were cases of proteinuria or abnormal liver-function tests.

Side Effects by Body System

General

Ramipril is generally well-tolerated. Most side effects are reported as often in patients taking placebo. Less than 3% of patients discontinue ramipril 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 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 (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.

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.

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 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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