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What is Micardis (telmisartan)?
Micardis (telmisartan) is an angiotensin receptor blocker (ARB) used to treat high blood pressure (hypertension) and to reduce the risk of heart attack, stroke, or death from cardiovascular causes in patients 55 years of age or older who are at high risk for developing major cardiovascular events and unable to take ACE inhibitors.
Angiotensin, formed in the blood by the action of angiotensin converting enzyme (ACE), is a powerful chemical that attaches to angiotensin receptors found in many tissues but primarily on muscle cells of blood vessels. Angiotensin’s attachment to the receptors causes muscle cells to shorten and narrow the blood vessels (vasoconstrict), which leads to an increase in blood pressure (hypertension).
Micardis blocks the angiotensin receptor. By blocking the action of angiotensin, Micardis widens blood vessels (vasodilate) and reduces blood pressure.
Common side effects of Micardis include:
- back pain,
- stomach upset,
- upper respiratory tract infections,
- high blood potassium (hyperkalemia),
- impotence, and
Serious side effects of Micardis include:
- reduced kidney function allergic reactions,
- rhabdomyolysis (inflammation and destruction of muscle), and
- angioedema (swelling of soft tissues including those of the throat and larynx).
Combining Micardis with potassium-sparing diuretics may lead to elevated potassium in the blood (hyperkalemia), including:
- potassium supplements, or
- salt substitutes containing potassium.
Combining Micardis or other ARBs with nonsteroidal anti-inflammatory drugs (NSAIDs) in patients who are elderly, fluid-depleted (including those on diuretic therapy), or with poor kidney function may result in reduced kidney function, including kidney failure.
Aspirin and other NSAIDs may reduce the effects of ARBs.
Medications that interfere with the angiotensin converting enzyme system, such as Micardis, have been found to cause fetal and neonatal toxicity and death when taken by pregnant women. Pregnant mothers should discontinue use of Micardis as soon as they know they are pregnant.
It is unknown if Micardis is secreted into breast milk. Since most medicines are secreted into breast milk, potential risks and benefits need to be assessed in women who are nursing to determine if breastfeeding or Micardis should be discontinued.
What are the important side effects of Micardis (telmisartan)?
Like other angiotensin receptor blockers, telmisartan generally is well-tolerated. The most common side effects are:
- back pain,
- stomach upset,
- upper respiratory tract infections,
- hyperkalemia, and
Patients also may experience impotence, reduced renal function, and allergic reactions. Rhabdomyolysis (inflammation and destruction of muscle) and angioedema (swelling of soft tissues including those of the throat and larynx) are rare but serious side effects of telmisartan.
Micardis (telmisartan) side effects list for healthcare professionals
The following adverse reactions are discussed elsewhere in labeling:
Clinical Trials Experience
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
Micardis HCT has been evaluated for safety in more than 1700 patients, including 716 treated for hypertension for longer than 6 months and 420 for more than 1 year. Adverse reactions have been limited to those that have been previously reported with telmisartan and/or hydrochlorothiazide.
Adverse reactions occurring at an incidence of =2% in patients treated with telmisartan/hydrochlorothiazide and at a greater rate than in patients treated with placebo, are presented in Table 1.
Table 1 Adverse Reactions Occurring at an Incidence of ≥2% in Patients Treated with Telmisartan/Hydrochlorothiazide and at a Greater Rate Than in Patients Treated with Placebo*
(n = 414)
(n = 74)
(n = 209)
(n = 121)
|Body as a whole|
|Central/Peripheral nervous system|
|Respiratory system disorder|
|Upper respiratory tract infection||8%||7%||7%||10%|
|* includes all doses of telmisartan (20 to 160 mg), hydrochlorothiazide (6.25 to 25 mg), and combinations thereof|
Other adverse reactions observed for telmisartan/hydrochlorothiazide were:
Adverse reactions occurred at approximately the same rates in men and women, older and younger patients, and black and non-black patients.
Other adverse events that have been reported with telmisartan are listed below:
Urinary: micturition frequency, cystitis
Vascular: cerebrovascular disorder
Other adverse events that have been reported with hydrochlorothiazide are listed below:
Body as a Whole: weakness
Hypersensitivity: purpura, photosensitivity, urticaria, necrotizing angiitis (vasculitis and cutaneous vasculitis), fever, respiratory distress including pneumonitis and pulmonary edema, anaphylactic reactions
Metabolic: hyperglycemia, glycosuria
Musculoskeletal: muscle spasm
Nervous System/Psychiatric: restlessness
Renal: interstitial nephritis
Skin: erythema multiforme including Stevens-Johnson syndrome, exfoliative dermatitis including toxic epidermal necrolysis
Special Senses: transient blurred vision, xanthopsia
Clinical Laboratory Findings
Creatinine, Blood Urea Nitrogen (BUN)
Increases in BUN (=11.2 mg/dL) and serum creatinine (=0.5 mg/dL) were observed in 2.8% and 1.4%, respectively, of patients with essential hypertension treated with Micardis HCT tablets in controlled trials. No patient discontinued treatment with Micardis HCT tablets because of an increase in BUN or creatinine.
The following adverse reactions have been identified during post-approval use of Micardis HCT. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate reliably their frequency or establish a causal relationship to drug exposure.
Blood and Lymphatic System Disorders: eosinophilia
General Disorders and Administration Site Conditions: asthenia, edema
Hepato-biliary: Abnormal hepatic function/liver disorder
Immune System Disorders: anaphylactic reaction
Infections and Infestations: urinary tract infection
Investigations: increased CPK
Musculoskeletal and Connective Tissue Disorders: tendon pain (including tendonitis, tenosynovitis), rhabdomyolysis
Reproductive System and Breast Disorders: erectile dysfunction
Respiratory, Thoracic and Mediastinal Disorders: coughing
Vascular Disorder: orthostatic hypotension
What drugs interact with Micardis (telmisartan)?
Agents Increasing Serum Potassium
Co-administration of telmisartan with other drugs that raise serum potassium levels may result in hyperkalemia. Monitor serum potassium in such patients.
Increases in serum lithium concentrations and lithium toxicity have been reported with concomitant use of thiazide diuretics or angiotensin II receptor antagonists, including telmisartan. Monitor lithium levels in patients receiving Micardis HCT and lithium.
Non-Steroidal Anti-Inflammatory Agents Including Selective Cyclooxygenas E-2 Inhibitors
Non-Steroidal Anti-Inflammatory Agents including Selective Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors): In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, co-administration of NSAIDs, including selective COX-2 inhibitors, with ARBs, including telmisartan, may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. The antihypertensive effect of ARBs may be attenuated by NSAIDs. Therefore, monitor renal function and blood pressure periodically in patients receiving Micardis HCT and NSAIDs.
Administration of a non-steroidal anti-inflammatory agent, including a selective COX2 inhibitor, can reduce the diuretic, natriuretic, and antihypertensive effects of diuretics. Therefore, when Micardis HCT and non-steroidal anti-inflammatory agents including selective COX2 inhibitors are used concomitantly, observe closely to determine if the desired effect of the diuretic is obtained.
Dual Blockade Of The Renin-Angiotens In-Aldosterone System And Changes In Renal Function
Dual blockade of the renin-angiotensin-aldosterone system (RAS) with angiotensin blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, hyperkalemia, and renal impairment. The ONTARGET trial enrolled 25,620 patients ≥55 years old with atherosclerotic disease or diabetes with end-organ damage, randomizing them to telmisartan (ARB) only, ramipril (ACE inhibitor) only, or the combination, and followed them for a median of 56 months.
Patients who received the combination of ARB and ACE inhibitor did not obtain any additional benefit (no additional reduction of risk of cardiovascular death, myocardial infarction, stroke, or hospitalization from heart failure) compared to ARB monotherapy or ACE inhibitor monotherapy, but experienced an increased incidence of renal dysfunction (e.g., acute renal failure) compared with monotherapy groups.
In general, avoid combined use of RAS inhibitors. Closely monitor blood pressure, renal function and electrolytes in patients on Micardis HCT and other agents that affect the RAS.
Do not co-administer aliskiren with Micardis HCT in patients with diabetes. Avoid concomitant use of aliskiren with Micardis HCT in patients with renal impairment (GFR <60 mL/min/1.73 m2).
When telmisartan was co-administered with digoxin, median increases in digoxin peak plasma concentration (49%) and in trough concentration (20%) were observed. Monitor digoxin levels in patients taking concomitant Micardis HCT and digoxin.
Antidiabetic Drugs (Oral Agents And Insulin)
Dosage adjustment of antidiabetic drugs may be required when coadministered with hydrochlorothiazide.
Cholestyramine And Colestipol Resins
Absorption of hydrochlorothiazide is impaired in the presence of anionic exchange resins. Stagger the dosage of hydrochlorothiazide and the resin such that hydrochlorothiazide is administered at least 4 hours before or 4 to 6 hours after the administration of the resin.
Micardis (telmisartan) is an angiotensin receptor blocker (ARB) used to treat high blood pressure (hypertension) and to reduce the risk of heart attack, stroke, or death from cardiovascular causes in patients 55 years of age or older who are at high risk for developing major cardiovascular events and unable to take ACE inhibitors. Common side effects of Micardis include headache, dizziness, back pain, fatigue, stomach upset, upper respiratory tract infections, high blood potassium (hyperkalemia), impotence, and diarrhea. Medications that interfere with the angiotensin converting enzyme system, such as Micardis, have been found to cause fetal and neonatal toxicity and death when taken by pregnant women. Pregnant mothers should discontinue use of Micardis as soon as they know they are pregnant. It is unknown if Micardis is secreted into breast milk.
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Second Source WebMD Medical Reference
High Blood Pressure (Hypertension) Signs, Causes, Diet, and Treatment
High blood pressure (hypertension) is a disease in which pressure within the arteries of the body is elevated. About 75 million people in the US have hypertension (1 in 3 adults), and only half of them are able to manage it. Many people do not know that they have high blood pressure because it often has no has no warning signs or symptoms. Systolic and diastolic are the two readings in which blood pressure is measured. The American College of Cardiology released new guidelines for high blood pressure in 2017. The guidelines now state that blood normal blood pressure is 120/80 mmHg. If either one of those numbers is higher, you have high blood pressure. The American Academy of Cardiology defines high blood pressure slightly differently. The AAC considers 130/80 mm Hg. or greater (either number) stage 1 hypertension. Stage 2 hypertension is considered 140/90 mm Hg. or greater. If you have high blood pressure you are at risk of developing life threatening diseases like stroke and heart attack.REFERENCE: CDC. High Blood Pressure. Updated: Nov 13, 2017.
Pulmonary hypertension is elevated pressure in the pulmonary arteries that carry blood from the lungs to the heart. The most common symptoms are fatigue and difficulty breathing. If the condition goes undiagnosed, more severe symptoms may occur. As pulmonary hypertension worsens, some people with the condition have difficulty performing any activities that require physical exertion. While there is no cure for pulmonary hypertension, it can be managed and treated with medications and supplemental oxygen to increase blood oxygen levels.
Pseudotumor Cerebri (Idiopathic Intracranial Hypertension)
Pseudotumor Cerebri (intracranial hypertension) is a condition where there is an increase in pressure of fluid surrounding the brain and spinal cord (cerebrospinal fluid or CSF) mimicing a brain tumor. The cause is unknown. The most common symptom is headache but also include eye-pain, vision loss and double vision. Pseudotumor cerebri is diagnosed with MRI or CAT scans and treated by discontinuing offending medications (if applicable), weight loss and diuretic medications. The condition can also be helped by repeated drainage of spinal fluid using the lumbar puncture.
Preeclampsia (Pregnancy Induced Hypertension)
Preeclampsia is related to increased blood pressure and protein in the mother's urine. Preeclampsia typically begins after the 20th week of pregnancy. When preeclampsia causes seizures, it is termed "eclampsia" and is the second leading cause of maternal death of in the US. Preeclampsia is the leading cause of fetal complications. Risk factors for preeclampsia include high blood pressure, obesity, multiple births, and women with preexisting medical conditions such as diabetes, kidney disease, rheumatoid arthritis, lupus, or scleroderma. Pregnancy planning and lifestyle changes may reduce the risk of preeclampsia during pregnancy.
Portal hypertension is most commonly caused by cirrhosis, a disease that results from scarring of the liver. Other causes of portal hypertension include blood clots in the portal vein, blockages of the veins that carry the blood from the liver to the heart, and a parasitic infection called schistosomiasis. Symptoms of portal hypertension include varices (enlarged veins), vomiting blood, blood in the stool, black and tarry stool, ascites (abnormal fluid collection within the peritoneum, the sac that contains the intestines within the abdominal cavity), confusion and lethargy, splenomegaly or enlargement of the spleen, and decreased white blood cell counts.
Hypertensive Kidney Disease
High blood pressure can damage the kidneys and is one of the leading causes of kidney failure (end-stage renal kidney disease). Kidney damage, like hypertension, can be unnoticeable and detected only through medical tests. If you have kidney disease, you should control your blood pressure. Other treatment options include prescription medications.
Treatment & Diagnosis
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Report Problems to the Food and Drug Administration
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.
Professional side effects and drug interactions sections courtesy of the U.S. Food and Drug Administration.