Ramipril (Altace) Risks, Warnings, and Complications

SERIOUS ALLERGIC REACTIONS: There are reports of angioedema, a potentially life-threatening allergic reaction, in patients receiving ramipril. Angioedema is a swelling of the head and neck and it can be fatal if it causes closing of the throat. The risk of ACE inhibitor associated angioedema is higher in Black patients, those who have had angioedema from other medicines, and those taking certain drugs called mTOR inhibitors (temsirolimus, sirolimus, everolimus). Stop taking ramipril and seek emergency medical care if you develop difficulty breathing or hoarseness. 

 Intestinal angioedema (swelling in the intestines) has also been reported after ACE inhibitor use. Symptoms may include severe stomach pain with or without nausea and vomiting. However, this condition may not cause any symptoms and be discovered only on imaging studies such as an ultrasound or abdominal CT scan. The symptoms resolve once the ACE inhibitor is stopped.

 Life-threatening anaphylactoid reactions (throat closing) have been reported in patients receiving ACE inhibitors. The risk of this occurring is higher in people receiving hymenoptera venom immunotherapy for desensitization against insect bites, those undergoing dialysis, and people with impaired renal function. Seek emergency medical help if you develop hoarseness or trouble breathing or swallowing.

LIVER FAILURE: Patients receiving ramipril can develop jaundice, which can progress to fulminant hepatic necrosis (liver failure), and even death. Before starting treatment, tell your doctor if you have a history of liver disease. Call your doctor right away if you develop abdominal pain, yellowing of the skin or eyes, or dark urine while on ramipril. Your healthcare provider will discontinue this medication if you develop jaundice or a marked increase in liver enzymes.

WORSENING RENAL FUNCTION AND KIDNEY FAILURE: ACE inhibitors, including ramipril, affect the renin angiotensin system and can cause changes in kidney function, including an increase in BUN and serum creatinine and possible acute renal failure. Patients with medical conditions such as chronic kidney disease, renal artery stenosis, severe congestive heart failure, recent heart attack, or volume depletion are at a higher risk of developing acute renal failure on ramipril.  Tell your doctor right away if you have decreased urine output (this can be a sign your kidneys are not working properly). Your doctor may ask you to stop taking ramipril if you develop decreased renal function.

LOW BLOOD CELL COUNTS: Rarely, treatment with ACE inhibitors, including ramipril, can lead to low white blood cells, red blood cells, and platelets. In severe cases, bone marrow depression can occur. The risk of these hematological adverse effects is higher in people with collagen vascular diseases such as lupus or scleroderma and those with reduced kidney function. Keep all your medical and laboratory appointments during ramipril therapy. Your doctor may want to order blood tests to keep an eye on your blood counts. 

HYPOTENSION: Ramipril is used to treat increased blood pressure and can sometimes cause hypotension (very low blood pressure). This is more likely to occur in people who are volume depleted or salt depleted, are on prolonged diuretic therapy (water pills), have diarrhea or vomiting, are undergoing dialysis, or have dietary salt restrictions. Drink enough fluids while on this medicine. Get up slowly from a sitting or lying position. If you develop signs of very low blood pressure (lightheadedness, dizziness, or fainting), lying down might help. Tell your doctor if these side effects are persistent. Your provider may lower your ramipril dose.

FETAL TOXICITY: Ramipril and other medications that affect the renin angiotensin aldosterone system can cause birth defects in an unborn baby if used during the second and third trimesters of pregnancy. Ramipril can cause compromised renal function in the fetus, resulting in oligohydramnios (too little amniotic fluid). This, in turn, can lead to skeletal deformities, underdevelopment of the baby’s lungs, low blood pressure, decreased renal function, renal failure, and even death. Before starting ramipril, tell your doctor if you are pregnant, could be pregnant, are planning a pregnancy soon, or are breast-feeding. Stop taking ramipril and call your doctor immediately if you become pregnant while on this medicine. Talk to your doctor about appropriate birth control while taking ramipril.

DRUG INTERACTIONS: Patients receiving ramipril with certain other medications such as telmisartan and aliskiren (which also affect the renin angiotensin system) are at an increased risk of serious adverse effects including hypotension (very low blood pressure), hyperkalemia (high blood potassium levels), and renal impairment (reduced kidney function including acute kidney failure). Your doctor will avoid prescribing two RAS inhibitors together because of these risks.

HYPERKALEMIA: Drugs such as ramipril that inhibit the renin angiotensin system can lead to high serum potassium levels (hyperkalemia). This usually resolves on its own and ramipril treatment does not need to be discontinued. Risk factors for hyperkalemia include renal insufficiency and diabetes mellitus. People taking potassium supplements, potassium-containing salt substitutes, or potassium-sparing diuretics (water pills) are at a higher risk of hyperkalemia. Your doctor will monitor potassium levels periodically while you are on ramipril. Tell your doctor right away if you develop symptoms such as nausea, muscle weakness, or fast or irregular heartbeat.

COUGH: A persistent dry cough is a common side effect of ACE inhibitor therapy. This usually resolves when the drug is discontinued.