Telmisartan — uses, dosing, side effects & the brands that sell it · pharmaranks
Telmisartan: uses, dosing, side effects & brands
Telmisartan is an angiotensin 2 receptor blocker sold in the U.S. under 2 brand and generic names, for diabetic nephropathies, heart failure and hypertension. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
By the pharmaranks editorial team·Reviewed against the FDA (openFDA label, NDC Directory & Enforcement) sources·How we research
Key facts
Drug class
Angiotensin 2 Receptor Blocker
Treats
Diabetic Nephropathies, Heart Failure and Hypertension
From the FDA label for Micardis (application NDA020850). Other telmisartan products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
2 DOSAGE & ADMINISTRATION • May be administered with or without food ( 2.1 ) • When used for cardiovascular risk reduction, monitoring of blood pressure is recommended, and if appropriate, adjustment of medications that lower blood pressure may be necessary ( 2.2 ) Indication Starting Dose Dose Range Hypertension ( 2.1 ) 40 mg once daily 40 to 80 mg once daily Cardiovascular Risk Reduction ( 2.2 ) 80 mg once daily 80 mg once daily 2.1 Hypertension Dosage must be individualized. The usual starting dose of telmisartan tablets is 40 mg orally once a day. Blood pressure response is dose-related over the range of 20 to 80 mg [ see Clinical Studies (14.1) ]. Most of the antihypertensive effect is apparent within 2 weeks and maximal reduction is generally attained after 4 weeks. No initial dosage adjustment is necessary for elderly patients or patients with renal impairment, including those on hemodialysis. Patients on dialysis may develop orthostatic hypotension; their blood pressure should be closely monitored. Telmisartan tablets may be administered with other antihypertensive agents. Telmisartan tablets may be administered with or without food. 2.2 Cardiovascular Risk Reduction The recommended dose of telmisartan tablets is 80 mg once a day and can be administered with or without food. It is not known whether doses lower than 80 mg of telmisartan are effective in reducing the…
Telmisartan side effects
The following adverse reaction is described elsewhere in labeling: Renal dysfunction upon use with ramipril [ see Warnings and Precautions (5.6) ] • Hypertension: The most common adverse events (≥1%) reported in hypertension trials are back pain, sinusitis, and diarrhea ( 6.1 ) • Cardiovascular risk reduction: The serious adverse events (≥1%) reported in cardiovascular risk reduction trials were intermittent claudication and skin ulcer ( 6.1) To report SUSPECTED ADVERSE REACTIONS, contact Modavar Pharmaceuticals LLC At 800-688-4697, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reactions 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. Hypertension Telmisartan has been evaluated for safety in more than 3700 patients, including 1900 treated for over 6 months and more than 1300 for over one year. Adverse experiences have generally been mild and transient in nature and have infrequently required discontinuation of therapy. In placebo-controlled trials involving 1041 patients treated with various doses of telmisartan (20 to 160 mg) monotherapy for up to 12 weeks, the overall incidence of adverse events was similar to that in patients treated…
Telmisartan and food
Potassium-rich foods & salt substitutes
Don't use potassium-based salt substitutes unless your clinician approves, and ask before taking potassium supplements. Your clinician may check your potassium level with blood tests.
Telmisartan is a non-peptide angiotensin II receptor (type AT 1 ) antagonist. Telmisartan is chemically described as 4'-[(1, 4'-dimethyl-2'-propyl [2,6'-bi-1H-benzimidazol]-1'-yl)methyl]-[1,1’-biphenyl]-2-carboxylic acid. Its empirical formula is C 33 H 30 N 4 O 2 , its molecular weight is 514.63, and its structural formula is: Telmisartan,USP is a white to slightly yellowish solid. It is practically insoluble in water and in the pH range of 3 to 9, sparingly soluble in strong acid (except insoluble in hydrochloric acid), and soluble in strong base. Telmisartan is available as tablets for oral administration, containing 20 mg, 40 mg or 80 mg of telmisartan,USP. The tablets contain the following inactive ingredients: sodium hydroxide, meglumine, povidone, mannitol, and magnesium stearate. telmisartan tablets are hygroscopic and require protection from moisture. telmisartan-fig1
What kind of drug is telmisartan?
The FDA classifies telmisartan as an angiotensin 2 receptor blocker. Angiotensin II receptor blockers (ARBs) block the AT1 receptor that the hormone angiotensin II uses to tighten blood vessels and make the body hold onto salt and water. With that receptor blocked, vessels relax and widen, so blood pressure falls. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
Can you take telmisartan with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run telmisartan against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What brand names is telmisartan sold under?
We track 2 telmisartan-containing products in the U.S.: Micardis and Telmisartan. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.
What forms does telmisartan come in?
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Who shouldn’t take telmisartan
Telmisartan tablets are contraindicated in patients with known hypersensitivity (e.g., anaphylaxis or angioedema) to telmisartan or any other component of this product [ see Adverse Reactions (6.2) ]. Do not co-administer aliskiren with telmisartan tablets in patients with diabetes [ see Drug Interactions (7) ]. • Known hypersensitivity (e.g., anaphylaxis or angioedema) to telmisartan or any other component of this product ( 4 ) • Do not co-administer aliskiren with telmisartan in patients with diabetes ( 4 )
Telmisartan drug interactions
Aliskiren: Do not co-administer aliskiren with telmisartan in patients with diabetes. Avoid use of aliskiren with telmisartan in patients with renal impairment (GFR <60 mL/min). Digoxin: When telmisartan was co-administered with digoxin, median increases in digoxin peak plasma concentration (49%) and in trough concentration (20%) were observed. Therefore, monitor digoxin levels when initiating, adjusting, and discontinuing telmisartan for the purpose of keeping the digoxin level within the therapeutic range. Lithium : Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin II receptor antagonists including telmisartan. Therefore, monitor serum lithium levels during concomitant use. 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 angiotensin II receptor antagonists, including telmisartan, may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically in patients receiving telmisartan and NSAID therapy. The antihypertensive effect of angiotensin…
Across the brands we track, telmisartan is currently marketed as tablet, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic telmisartan?
Yes. Our catalog lists 1 generic telmisartan product alongside the brand versions. A generic has the same active ingredient and must meet the FDA's bioequivalence standard; it usually costs less. Ask your pharmacist which one your plan covers.
Has telmisartan been recalled?
The FDA's Enforcement database lists 1 recall record whose product description mentions telmisartan. The most recent: Telmisartan Tablets (Feb 9, 2024). A recall applies to specific lots, not to the drug as a whole — check the record for the affected lot numbers.