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Altace Side Effects

Generic Name: ramipril

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

Not all side effects for Altace may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to ramipril: oral capsule, oral tablet

In addition to its needed effects, some unwanted effects may be caused by ramipril (the active ingredient contained in Altace). In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking ramipril:

More common
  • Blurred vision
  • confusion
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • sweating
  • unusual tiredness or weakness
Less common
  • Arm, back, or jaw pain
  • chest pain or discomfort
  • chest tightness or heaviness
  • chills
  • cloudy urine
  • cold sweats
  • decrease in urine output or decrease in urine-concentrating ability
  • fainting
  • fast or irregular heartbeat
  • nausea
  • shortness of breath

Some of the side effects that can occur with ramipril may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common
  • Cough
Less common
  • Diarrhea
  • feeling of constant movement of self or surroundings
  • sensation of spinning
  • vomiting

For Healthcare Professionals

Applies to ramipril: oral capsule, oral tablet

General

The most common adverse reaction is hypotension.[Ref]

Cardiovascular

Very common (10% or more): Hypotension (11%)
Common (1% to 10%): Angina pectoris, postural hypotension, orthostatic blood pressure decreased
Uncommon (0.1% to 1%): Symptomatic hypotension, myocardial ischemia, myocardial infarction, tachycardia, arrhythmia, palpitation, flushing
Rare (less than 0.1%): Vascular stenosis, hypoperfusion, vasculitis
Frequency not reported: Disturbed orthostatic regulation, Raynaud's phenomenon[Ref]

Gastrointestinal

Common (1% to 10%): Nausea, vomiting, diarrhea, gastrointestinal inflammation, digestive disturbances, abdominal discomfort, dyspepsia
Uncommon (0.1% to 1%): Pancreatitis, pancreatic enzymes increased, abdominal pain, small bowel angioedema, gastritis, constipation, dry mouth
Rare (less than 0.1%): Glossitis
Frequency not reported: Dysphagia, gastroenteritis, increased salivation, gastric pain, aphthous stomatitis[Ref]

Other

Common (1% to 10%): Fatigue, asthenia, vertigo, bronchitis, sinusitis, chest pain
Uncommon (0.1% to 1%): Peripheral edema, pyrexia, libido decreased
Rare (less than 0.1%): Conjunctivitis, hearing impaired, tinnitus
Frequency not reported: Hearing loss, edema, malaise, gynecomastia[Ref]

Respiratory

Common (1% to 10%): Cough, nonproductive tickling cough, cough increased, dyspnea
Uncommon (0.1% to 1%): Bronchospasm, asthma aggravated
Frequency not reported: Eosinophilic pneumonitis, epistaxis, nasal congestion[Ref]

Psychiatric

Uncommon (0.1% to 1%): Depressed mood, anxiety, nervousness, restlessness, sleep disorder
Rare (less than 0.1%): Confusional state
Frequency not reported: Depression, insomnia, disturbance in attention[Ref]

Nervous system

Common (1% to 10%): Headache, dizziness, syncope
Uncommon (0.1% to 1%): Paresthesia, dysgeusia, ageusia, somnolence
Rare (less than 0.1%): Tremor, balance disorder
Frequency not reported: Smell disturbance, amnesia, convulsions, neuralgia, neuropathy, cerebral ischemia, ischemic stroke, transient ischemic attack, psychomotor skills impaired, burning sensation, parosmia[Ref]

Musculoskeletal

Common (1% to 10%): Muscle spasm, myalgia
Uncommon (0.1% to 1%): Arthralgia
Frequency not reported: Arthritis[Ref]

Dermatologic

Common (1% to 10%): Maculopapular rash
Uncommon (0.1% to 1%): Pruritus, hyperhidrosis
Rare (less than 0.1%): Exfoliative dermatitis, urticaria, onycholysis
Frequency not reported: Purpura, pemphigus, pemphigoid, erythema multiforme, toxic epidermal necrolysis, Stevens Johnson syndrome, sweating increased, alopecia, psoriasis aggravated, dermatitis psoriasiform, lichenoid exanthema, enanthema[Ref]

Renal

Common (1% to 10%): Abnormal kidney function
Uncommon (0.1% to 1%): Renal impairment, acute renal failure[Ref]

Metabolic

Common (1% to 10%): Creatinine increased, blood potassium increased
Uncommon (0.1% to 1%): Anorexia, decreased appetite, BUN increased
Frequency not reported: Weight gain, hyponatremia, loss of appetite, uric acid elevated, blood glucose elevated, blood sodium decreased
Postmarketing reports: Hypoglycemia[Ref]

Genitourinary

Uncommon (0.1% to 1%): Worsening of preexisting proteinuria, urine output increased, transient erectile impotence
Frequency not reported: Proteinuria, impotence[Ref]

Ocular

Uncommon (0.1% to 1%): Visual disturbance, blurred vision[Ref]

Hematologic

Uncommon (0.1% to 1%): Eosinophilia, hemoglobin or hematocrit decreased
Rare (less than 0.1%): Neutropenia, agranulocytosis, white blood cell count decreased, red blood cell count decreased, platelet count decreased
Frequency not reported: Pancytopenia, hemolytic anemia, thrombocytopenia, leucopenia, bone marrow failure[Ref]

Hepatic

Uncommon (0.1% to 1%): Hepatic enzymes increased, conjugated bilirubin increased
Rare (less than 0.1%): Cholestatic jaundice, hepatocellular damage
Frequency not reported: Hepatic failure, hepatitis, jaundice, acute liver failure, hepatocellular damage, cholestatic hepatitis, cytolytic hepatitis, serum bilirubin elevated[Ref]

Immunologic

Uncommon (0.1% to 1%): Angioneurotic edema, angioedema
Very rare (less than 0.01%): Photosensitivity
Frequency not reported: Anaphylactic reaction, anaphylactoid reaction, apparent hypersensitivity reaction, antinuclear antibody increased[Ref]

Endocrine

Frequency not reported: Syndrome of inappropriate antidiuretic hormone secretion[Ref]

References

1. Cerner Multum, Inc. "Australian Product Information." O 0

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

3. "Product Information. Altace (ramipril)." Hoechst Marion-Roussel Inc, Kansas City, MO.

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