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Altace Capsules

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Altace Capsules

Altace Capsules Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Altace Capsules (ramipril capsules) are used to treat high blood pressure (hypertension). Altace belongs in a class of drugs called angiotensin converting enzyme (ACE) inhibitors. This product is available in generic form. Common side effects include dizziness, lightheadedness, or tiredness as your body adjusts to the medication. Dry cough may also occur. Serious swelling of the lips, tongue, and throat called angioedema may occur with drugs of this class (ACE inhibitors). Stop medication and contact your doctor immediately if any of the listed side effects occur.

The recommended initial dose for Altace is 2.5 mg once per day initially. Dosage may be gradually increased as needed and if tolerated. Medications that may interact with this drug include diuretics (water pills), lithium, potassium supplements, salt substitutes containing potassium, aspirin or other NSAIDs such as ibuprofen and naproxen. A very serious reaction may occur if you are getting injections for bee/wasp sting allergy and are also taking Altace. Tell your doctor all medicines you are using. This medication is not recommended for use during pregnancy as it may harm a developing fetus. It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

Our Altace Capsules Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Altace Capsules in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: 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 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. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Altace Capsules (Ramipril Capsules) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Altace Capsules Overview - Patient Information: Side Effects

SIDE EFFECTS: Dizziness, lightheadedness, or tiredness may occur as your body adjusts to the medication. Dry cough may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if any of these unlikely but serious side effects occur: fainting, symptoms of a high potassium blood level (such as muscle weakness, slow/irregular heartbeat), signs of infection (such as fever, chills, persistent sore throat), change in the amount of urine.

This drug may rarely cause serious (possibly fatal) liver problems. Tell your doctor right away if you notice any of the following rare but serious side effects: yellowing eyes/skin, dark urine, severe stomach/abdominal pain, persistent nausea/vomiting.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Altace Capsules (Ramipril Capsules)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Altace Capsules FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Hypertension

ALTACE (ramipril capsules) 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 (ramipril capsules) and placebo patients. The most frequent clinical side effects (possibly or probably related to study drug) reported by patients receiving ALTACE (ramipril capsules) 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 (ramipril capsules) 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 (ramipril capsules) . 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 (ramipril capsules) , only asthenia (fatigue) was more common on Altace (ramipril capsules) than placebo (2% vs. 1%).

PATIENTS IN US PLACEBO CONTROLLED STUDIES

  ALTACE Placebo
(n=651) (n=286)
n % n %
Asthenia (Fatigue) 13 2 2 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

Adverse Event Ramipril Placebo
(n=1004) (n=982)
Hypotension 11 5
Cough Increased 8 4
Dizziness 4 3
Angina Pectoris 3 2
Nausea 2 1
Postural Hypotension 2 1
Syncope 2 1
Vomiting 2 0.5
Vertigo 2 0.7
Abnormal Kidney Function 1 0.5
Diarrhea 1 0.4

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 (see WARNINGS).

  RAMIPRIL PLACEBO
(N=4645) (N=4652)
% %
Discontinuation at any time 34 32
Permanent discontinuation 29 28
Reasons for stopping Cough 7 2
Hypotension or Dizziness 1.9 1.5
Angioedema 0.3 0.1

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. (See WARNINGS.)

Cardiovascular: Symptomatic hypotension (reported in 0.5% of patients in US trials) (See WARNINGS and PRECAUTIONS ), 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 (ramipril capsules) , particularly when ALTACE (ramipril capsules) was given concomitantly with a diuretic. (See WARNINGS.) Acute renal failure.

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

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 (ramipril capsules) 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 (ramipril capsules) alone, and in 1.5% of patients receiving ALTACE (ramipril capsules) and a diuretic. Increases in blood urea nitrogen levels occurred in 0.5% of patients receiving ALTACE (ramipril capsules) alone and in 3% of patients receiving ALTACE (ramipril capsules) 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. (See WARNINGS and PRECAUTIONS.) 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. (See WARNINGS and PRECAUTIONS.)

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 (ramipril capsules) alone and in 1.5% of patients receiving ALTACE (ramipril capsules) 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 (ramipril capsules) 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.

Read the entire FDA prescribing information for Altace Capsules (Ramipril Capsules) »

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Altace Capsules - User Reviews

Altace Capsules User Reviews

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Here is a collection of user reviews for the medication Altace Capsules sorted by most helpful. Patient Discussions FAQs

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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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