Telmisartan Recall

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Side Effects & Adverse Reactions

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Legal Issues

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FDA Safety Alerts

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Manufacturer Warnings

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FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.


1.1 Hypertension

Telmisartan tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs.

Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).

Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.

Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.

Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.

It may be used alone or in combination with other antihypertensive agents [see Clinical Studies (14.1)].

Use of telmisartan and an ACE inhibitor is not recommended [see Warnings and Precautions (5.6)].


There is currently no drug history available for this drug.

Other Information

Telmisartan tablets, USP are a non-peptide angiotensin II receptor (type AT1) 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 molecular formula is C33H30N4O2, its molecular weight is 514.63, and its structural formula is:

The chemical structure for Telmisartan

Telmisartan 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 tablets, USP are available as tablets for oral administration, containing 20 mg, 40 mg or 80 mg of telmisartan. The tablets contain the following inactive ingredients: magnesium stearate, mannitol, meglumine and sodium hydroxide. Telmisartan tablets, USP are hygroscopic and require protection from moisture.

Telmisartan Manufacturers

  • Watson Laboratories, Inc.
    Telmisartan Tablet [Watson Laboratories, Inc.]
  • Roxane Laboratories, Inc.
    Telmisartan Tablet [Roxane Laboratories, Inc.]
  • Glenmark Generics Inc., Usa
    Telmisartan Tablet [Glenmark Generics Inc., Usa]
  • Qualitest Pharmaceuticals
    Telmisartan Tablet [Qualitest Pharmaceuticals]
  • Alembic Pharmaceuticals Limited
    Telmisartan Tablet [Alembic Pharmaceuticals Limited]
  • Mylan Pharmaceuticals Inc.
    Telmisartan Tablet [Mylan Pharmaceuticals Inc.]
  • Torrent Pharmaceuticals Limited
    Telmisartan Tablet [Torrent Pharmaceuticals Limited]
  • Zydus Pharmaceuticals (Usa) Inc.
    Telmisartan Tablet [Zydus Pharmaceuticals (Usa) Inc.]
  • Cadila Healthcare Limited
    Telmisartan Tablet [Cadila Healthcare Limited]
  • Aurobindo Pharma Limited
    Telmisartan Tablet [Aurobindo Pharma Limited]
  • Medsource Pharmaceuticals
    Telmisartan Tablet [Medsource Pharmaceuticals]

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