Looking up the FDA label…
Looking up the FDA label…
FDA boxed warning
WARNING: FETAL TOXICITY When pregnancy is detected, discontinue azilsartan medoxomil tablets as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. When pregnancy is detected, discontinue azilsartan medoxomil tablets as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.
Azilsartan medoxomil tablets are indicated for the treatment of hypertension in adults, 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. There are no controlled trials demonstrating risk reduction with azilsartan medoxomil tablets. 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). …
Advise the patient to read the FDA-approved patient labeling (Patient Information) Pregnancy Tell female patients of childbearing potential about the consequences of exposure to Azilsartan medoxomil tablets during pregnancy. Discuss treatment options with women planning to become pregnant. Tell patients to report pregnancies to their physicians as soon as possible. LUPIN and the are registered trademarks of Lupin Pharmaceuticals, Inc. Manufactured for: Lupin Pharmaceuticals, Inc. Naples, FL 34108 United States. Manufactured by: Lupin Limited, Nagpur - 441 108, India. February 2026 ID#: 282780 Image
The most common adverse reaction in adults was diarrhea (2%). To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc. at 1-800-399-2561 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. A total of 4814 pati…
Having one of these?
A doctor will tell you whether it matters and what to do about it. Written answer, a week of free follow-ups.
Ask a doctor — $19.99Do not coadminister aliskiren-containing products with azilsartan medoxomil tablets in patients with diabetes. Do not coadminister aliskiren-containing products with azilsartan medoxomil tablets in patients with diabetes.
The recommended dose in adults is 80 mg taken once daily. Consider a starting dose of 40 mg for patients who are treated with high doses of diuretics. Azilsartan medoxomil tablets may be administered with or without food. Azilsartan medoxomil may be administered with other antihypertensive agents. 2.1 Recommended Dose The recommended dose in adults is 80 mg taken orally once daily. Consider a starting dose of 40 mg for patients who are treated with high doses of diuretics. 2.2 Handling Instructions Do not repackage…
Dual inhibition of the renin-angiotensin system: Increased risk of renal impairment, hypotension and hyperkalemia. Lithium: Increases in serum lithium concentrations and lithium toxicity. 7.1 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 who have compromised renal function, coadministration of NSAIDs, including selective COX-2 inhibitors, with angiotensin II receptor ant…
Taking something else alongside it?
Interaction warnings are written per drug, not for your particular combination. A doctor can check yours.
Ask about my combinationWorks in a similar way — angiotensin ii receptor blockers (arbs)
These are different medicines in the same family, not swaps for each other. Which one suits you is a prescribing decision.