pharmacopeia
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/api/v1/drug/telmisartan

Boxed warning

FETAL TOXICITY When pregnancy is detected, discontinue telmisartan as soon as possible [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1) ]. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1) ] WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. When pregnancy is detected, discontinue telmisartan as soon as possible ( 5.1 , 8.1 ) Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus ( 5.1 , 8.1 )

2D structure
2-[4-[[4-methyl-6-(1-methylbenzimidazol-2-yl)-2-propylbenzimidazol-1-yl]methyl]phenyl]benzoic acid
SMILES CCCC1=NC2=C(N1CC3=CC=C(C=C3)C4=CC=CC=C4C(=O)O)C=C(C=C2C)C5=NC6=CC=CC=C6N5C
InChIKey RMMXLENWKUUMAY-UHFFFAOYSA-N

Mechanism of action

Sourced from openFDA

Angiotensin II is formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme (ACE, kininase II). Angiotensin II is the principal pressor agent of the reninangiotensin system, with effects that include vasoconstriction, stimulation of synthesis and release of aldosterone, cardiac stimulation, and renal reabsorption of sodium.

Angiotensin 2 Receptor

Indications

Sourced from openFDA
  • Telmisartan tablets, USP are an angiotensin II receptor blocker (ARB) indicated for: Treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.ICD-10: I10

Contraindications

Sourced from openFDA
  • Telmisartan is 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 in patients with diabetes.contraindicated

Dosage & administration

Sourced from openFDA

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 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 risk of cardiovascular morbidity and mortality.

Warnings & precautions

Sourced from openFDA

Avoid fetal or neonatal exposure ( 5.1 ) Hypotension: Correct any volume or salt depletion before initiating therapy. Observe for signs and symptoms of hypotension ( 5.2 ) Monitor carefully in patients with impaired hepatic ( 5.4 ) or renal function ( 5.5 ) Avoid concomitant use of an ACE inhibitor and angiotensin receptor blocker ( 5.6) 5.1 Fetal Toxicity Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue telmisartan as soon as possible [see Use in Specific Populations (8.1) ]. 5.2 Hypotension In patients with an activated renin-angiotensin system, such as volume- or salt-depleted patients (e.g., those being treated with high doses of diuretics), symptomatic hypotension may occur after initiation of therapy with telmisartan. Either correct this condition prior to administration of telmisartan, or start treatment under close medical supervision with a reduced dose. If hypotension does occur, the patient should be placed in the supine position and, if necessary, given an intravenous infusion of normal saline. A transient hypotensive response is not a contraindication to further treatment, which usually can be continued without difficulty once the blood pressure has stabilized.

Adverse reactions

Sourced from openFDA

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 Ascend Laboratories, LLC at 1-877-272-7901 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 with placebo.

Use in specific populations

Sourced from openFDA

Lactation: Do not breastfeed during treatment with telmisartan ( 8.2 ) Geriatric Patients: No overall difference in efficacy or safety vs younger patients, but greater sensitivity of some older individuals cannot be ruled out ( 8.5 ) 8.1 Pregnancy Risk Summary Telmisartan can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death (see Clinical Considerations ). Most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the renin-angiotensin system from other antihypertensive agents. Studies in rats and rabbits with telmisartan showed fetotoxicity only at maternally toxic doses (see Data ). When pregnancy is detected, discontinue telmisartan as soon as possible. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Pharmacokinetics

Sourced from openFDA
Metabolism
Absorption: Following oral administration, peak concentrations (C max ) of telmisartan are reached in 0.5 to 1 hour after dosing. Food slightly reduces the bioavailability of telmisartan, with a reduction in the area under the plasma concentration-time curve (AUC) of about 6% with the 40 mg tablet and about 20% after a 160 mg dose.

Overdosage

Sourced from openFDA

Limited data are available with regard to overdosage in humans. The most likely manifestation of overdosage with telmisartan tablets would be hypotension, dizziness and tachycardia; bradycardia could occur from parasympathetic (vagal) stimulation. If symptomatic hypotension should occur, supportive treatment should be instituted. Telmisartan is not removed by hemodialysis.

Approval history

Sourced from openFDA
  • Nov 10, 1998NDANDA020850Boehringer Ingelheim
  • Nov 17, 2000NDANDA021162Boehringer Ingelheim
  • Jan 8, 2014ANDAANDA201586Lupin
  • Jan 8, 2014ANDAANDA078710Chartwell Rx
  • Feb 25, 2014ANDAANDA203010Alembic
  • Jul 7, 2014ANDAANDA090032Glenmark Pharms Ltd
  • Jul 7, 2014ANDAANDA202397Mylan
  • Jun 5, 2025NDANDA219423Azurity

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
36,463 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Nausea2,2216.1%
  2. 2Fatigue2,1585.9%
  3. 3Drug Ineffective2,0315.6%
  4. 4Diarrhoea1,9195.3%
  5. 5Dyspnoea1,9035.2%
  6. 6Headache1,8535.1%
  7. 7Dizziness1,8405.0%
  8. 8Fall1,7264.7%
  9. 9Blood Pressure Increased1,6524.5%
  10. 10Hypertension1,5544.3%
  11. 11Asthenia1,5284.2%
  12. 12Arthralgia1,5244.2%
  13. 13Malaise1,5164.2%
  14. 14Off Label Use1,4664.0%
  15. 15Vomiting1,4604.0%

Literature

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Recent PubMed references pinned to Telmisartan as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 347 ClinicalTrials.gov registrations naming Telmisartan as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Telmisartan work?
Angiotensin II is formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme (ACE, kininase II). Angiotensin II is the principal pressor agent of the reninangiotensin system, with effects that include vasoconstriction, stimulation of synthesis and release of aldosterone, cardiac stimulation, and renal reabsorption of sodium.
What is Telmisartan used for?
According to FDA labeling, Telmisartan carries indications including: Telmisartan tablets, USP are an angiotensin II receptor blocker (ARB) indicated for: Treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Telmisartan?
Telmisartan is classified as Angiotensin II receptor blockers (ARBs), plain, Angiotensin 2 Receptor Blocker, Angiotensin 2 Receptor Antagonists, Decreased Blood Pressure, Decreased Intravascular Volume, Decreased Mineralocorticoid Secretion, Decreased Renal K+ Excretion, Increased Renal Na+ Excretion, Renal Arterial Vasoconstriction, Renal Arterial Vasodilation.
What are the brand names for Telmisartan?
Telmisartan is marketed under brand names including Micardis, Micardis-HCT, Semintra, Twynsta, Widaplik.
What are the contraindications for Telmisartan?
Telmisartan labeling lists contraindications including: Telmisartan is 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 in patients with diabetes.. Always consult the full prescribing information and a clinician.
Note. Data for telmisartan is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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