Quick answers
- What is Azilsartan kamedoxomil used for?
- The FDA-approved label (Azilsartan Medoxomil, Wilshire Pharmaceuticals, Inc., April 20, 2026) says: “Azilsartan medoxomil is 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. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- What are the side effects of Azilsartan kamedoxomil?
- The “Adverse Reactions” section of the FDA label (Azilsartan Medoxomil, Wilshire Pharmaceuticals, Inc., April 20, 2026) begins: “The most common adverse reaction in adults was diarrhea (2%).” … This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- What are the drug interactions of Azilsartan kamedoxomil?
- The “Drug Interactions” section of the FDA label (Azilsartan Medoxomil, Wilshire Pharmaceuticals, Inc., April 20, 2026) begins: “Dual inhibition of the renin-angiotensin system: Increased risk of renal impairment, hypotension, and hyperkalemia. (7) Lithium: Increases in serum lithium concentrations and lithium toxicity.” … This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Azilsartan kamedoxomil have a boxed warning?
- Yes. The FDA label for Azilsartan Medoxomil has a boxed warning (“WARNING: FETAL TOXICITY”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Azilsartan kamedoxomil?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Azilsartan kamedoxomil been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started March 15, 2021 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Azilsartan kamedoxomil?
- 3 companies list prescription products of Azilsartan kamedoxomil in the FDA NDC Directory, including Wilshire Pharmaceuticals, Inc., Lupin Pharmaceuticals, Inc. and Azurity Pharmaceuticals, Inc.
What Azilsartan kamedoxomil is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Azilsartan medoxomil is 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. …
— FDA label: Azilsartan Medoxomil, Wilshire Pharmaceuticals, Inc., effective April 20, 2026. Read the full label on DailyMed →
Label quoted: the one for the most common form (tablet, oral), Azilsartan Medoxomil, Wilshire Pharmaceuticals, Inc.; it covers 2 products in the FDA NDC Directory. The side effects, interactions, dosage and pregnancy quotes below come from this same label.
The FDA has 3 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Its heading: WARNING: FETAL TOXICITY
. Read it on the full label →
3 of 3 FDA labels for this medicine have a boxed warning.
Azilsartan kamedoxomil boxed warning: what the label says
Quoted from the boxed warning of the FDA-approved label.
WARNING: FETAL TOXICITY When pregnancy is detected, discontinue azilsartan medoxomil 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.
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When pregnancy is detected, discontinue azilsartan medoxomil 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)
— FDA label: Azilsartan Medoxomil, Wilshire Pharmaceuticals, Inc., effective April 20, 2026. Read the full label on DailyMed →
Azilsartan kamedoxomil side effects
Quoted from the “Adverse Reactions” section of the FDA-approved label. Tell your doctor about any side effect that worries you.
The most common adverse reaction in adults was diarrhea (2%).
Read more of this section
(6.1) To report SUSPECTED ADVERSE REACTIONS, contact Wilshire Pharmaceuticals, Inc. at 1-877-495-6856 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 patients were evaluated for safety when treated with azilsartan medoxomil at doses of 20, 40, or 80 mg in clinical trials. This includes 1704 patients treated for at least six months; of these, 588 were treated for at least one year. Treatment with azilsartan medoxomil was well-tolerated with an overall incidence of adverse reactions similar to placebo. The rate of withdrawals due to adverse events in placebo-controlled monotherapy and combination therapy trials was 2.4% (19/801) for placebo, 2.2% (24/1072) for azilsartan medoxomil 40 mg, and 2.7% (29/1074) for azilsartan medoxomil 80 mg. The most common adverse event leading to discontinuation, hypotension/orthostatic hypotension, was reported by 0.4% (8/2146) patients randomized to azilsartan medoxomil 40 mg or 80 mg compared to 0% (0/801) patients randomized to placebo. Generally, adverse reactions were mild, not dose related, and similar regardless of age, gender, and race. In placebo-controlled monotherapy trials, diarrhea was reported up to 2% in patients treated with azilsartan medoxomil 80 mg daily compared with 0.5% of patients on placebo. Other adverse reactions with a plausible relationship to treatment that have been reported with an incidence of ≥0.3% and greater than placebo in more than 3300 patients treated with azilsartan medoxomil in controlled trials are listed below: Gastrointestinal Disorders: nausea General Disorders and Administration Site Conditions: asthenia, fatigue Musculoskeletal and Connective Tissue Disorders: muscle spasm Nervous System Disorders: dizziness, dizziness postural Respiratory, Thoracic, and Mediastinal Disorders: cough 6.2 Postmarketing Experience The following adverse reactions have been identified during the postmarketing use of azilsartan medoxomil. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Rash Pruritus Angioedema
— FDA label: Azilsartan Medoxomil, Wilshire Pharmaceuticals, Inc., effective April 20, 2026. Read the full label on DailyMed →
Azilsartan kamedoxomil drug interactions
Quoted from the “Drug Interactions” section of the FDA-approved label. Tell your pharmacist about every medicine, vitamin and herbal product you take.
Dual inhibition of the renin-angiotensin system: Increased risk of renal impairment, hypotension, and hyperkalemia. (7) Lithium: Increases in serum lithium concentrations and lithium toxicity.
Read more of this section
(7) 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 antagonists, including azilsartan, may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically in patients receiving azilsartan and NSAID therapy. The antihypertensive effect of angiotensin II receptor antagonists, including azilsartan, may be attenuated by NSAIDs, including selective COX-2 inhibitors. 7.2 Dual Blockade of the Renin-Angiotensin System (RAS) Dual blockade of the RAS with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy. Most patients receiving the combination of two RAS inhibitors do not obtain any additional benefit compared to monotherapy. In general, avoid combined use of RAS inhibitors. Closely monitor blood pressure, renal function and electrolytes in patients on azilsartan medoxomil and other agents that affect the RAS. Do not coadminister aliskiren with azilsartan medoxomil in patients with diabetes. Avoid use of aliskiren with azilsartan medoxomil in patients with renal impairment (GFR <60 mL/min). 7.3 Lithium Increases in serum lithium concentrations and lithium toxicity have been reported during concomitant administration of lithium with angiotensin II receptor agonists. Monitor serum lithium levels during concomitant use.
— FDA label: Azilsartan Medoxomil, Wilshire Pharmaceuticals, Inc., effective April 20, 2026. Read the full label on DailyMed →
Azilsartan kamedoxomil dosage
Quoted from the “Dosage and Administration” section of the FDA-approved label. Your own dose is the one your doctor prescribes: do not change it on your own.
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. (2.1) Azilsartan medoxomil may be administered with or without food. (2.1) Azilsartan medoxomil may be administered with other antihypertensive agents. (2.1) 2.1 Recommended Dose The recommended dose in adults is 80 mg taken orally once daily.
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Consider a starting dose of 40 mg for patients who are treated with high doses of diuretics. 2.2 Handling Instructions Do not repackage azilsartan medoxomil. Dispense and store azilsartan medoxomil in its original container to protect azilsartan medoxomil from light and moisture.
— FDA label: Azilsartan Medoxomil, Wilshire Pharmaceuticals, Inc., effective April 20, 2026. Read the full label on DailyMed →
Azilsartan kamedoxomil in pregnancy
Quoted from the pregnancy part of the FDA-approved label. Ask your doctor before you take any medicine while pregnant or planning a pregnancy.
Risk Summary Azilsartan medoxomil 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).
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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. When pregnancy is detected, discontinue azilsartan medoxomil 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 2-4% and 15-20%, respectively. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Hypertension in pregnancy increases the maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section, and post-partum hemorrhage). Hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death. Pregnant women with hypertension should be carefully monitored and managed accordingly. Fetal/Neonatal adverse reactions Oligohydramnios in pregnant women who use drugs affecting the renin-angiotensin system in the second and third trimesters can result in the following: reduced fetal renal function leading to anuria and renal failure, fetal lung hypoplasia, skeletal deformations, including skull hypoplasia, hypotension and death. Perform serial ultrasound examinations to assess the intra-amniotic environment. Fetal testing may be appropriate, based on the week of pregnancy. Patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury. Closely observe infants with histories of in utero exposure to azilsartan medoxomil for hypotension, oliguria, and hyperkalemia. In neonates with a history of in utero exposure to azilsartan medoxomil, if oliguria or hypotension occurs, support blood pressure and renal perfusion. Exchange transfusions or dialysis may be required as a means of reversing hypotension and/or substituting for disordered renal function. Data Animal Data In peri- and postnatal rat development studies, adverse effects on pup viability, delayed incisor eruption and dilatation of the renal pelvis along with hydronephrosis were seen when azilsartan medoxomil was administered to pregnant and nursing rats at 1.2 times the MRHD on a mg/m 2 basis.
— FDA label: Azilsartan Medoxomil, Wilshire Pharmaceuticals, Inc., effective April 20, 2026. This is part of the section. Read the full label on DailyMed →
When Azilsartan kamedoxomil should not be used
Quoted from the “Contraindications” section of the FDA-approved label.
Do not coadminister aliskiren-containing products with azilsartan medoxomil in patients with diabetes [see Drug Interactions (7)]. Do not coadminister aliskiren-containing products with azilsartan medoxomil in patients with diabetes. (4)
— FDA label: Azilsartan Medoxomil, Wilshire Pharmaceuticals, Inc., effective April 20, 2026. Read the full label on DailyMed →
Azilsartan kamedoxomil overdose
Quoted from the “Overdosage” section of the FDA-approved label. If someone may have taken too much, call Poison Help at 1-800-222-1222 (or 911 in an emergency).
Limited data are available related to overdosage in humans. During controlled clinical trials in healthy subjects, once-daily doses up to 320 mg of azilsartan medoxomil were administered for seven days and were well tolerated. In the event of an overdose, supportive therapy should be instituted as dictated by the patient's clinical status. Azilsartan is not dialyzable [see Clinical Pharmacology (12.3)].
— FDA label: Azilsartan Medoxomil, Wilshire Pharmaceuticals, Inc., effective April 20, 2026. Read the full label on DailyMed →
Forms and how it is given
| Dosage forms | Tablet |
|---|---|
| Route | Oral |
| Prescription products | 6 in the FDA NDC Directory |
| Brand names | Azilsartan Medoxomil, Edarbi |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| azilsartan kamedoxomil 40 mg tablet | Generic | $5.51 per tablet |
| azilsartan kamedoxomil 40 mg tablet | Brand: Edarbi | $8.28 per tablet |
| azilsartan kamedoxomil 80 mg tablet | Generic | $5.72 per tablet |
| azilsartan kamedoxomil 80 mg tablet | Brand: Edarbi | $9.01 per tablet |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Wilshire Pharmaceuticals, Inc.2 products
- Lupin Pharmaceuticals, Inc.2 products
- Azurity Pharmaceuticals, Inc.2 products
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA200796 EDARBI | Azurity | February 25, 2011 | 10, latest January 16, 2024 2024: Labeling · 2020: Labeling · 2016: Labeling |
Generic approvals (1)
- ANDA214489Lupin · July 20, 2022
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
March 15, 2021 · Class II · Terminated · D-0429-2021
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Edarbi (azilsartan medoxomil) tablets 80 mg 30 Tablets Rx Only NDC 60631-080-30 Manufactured for: arbor Pharmaceuticals Atlanta, GA 30328 — Cardinal Health Inc.
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 1091646, 1091650, 1091652, 1091654 |
|---|---|
| SPL set ID of the quoted label | c09103d8-c094-473d-a303-bbb4f334aa8c |
| FDA labels (SPL) | 3 |
| FDA applications | NDA200796, 1 ANDA |
| Active ingredients (FDA) | AZILSARTAN KAMEDOXOMIL |
Next steps
- Find a pharmacy near youAsk which price applies to you and whether your product is affected by a recall
- Latest FDA drug recallsAll medicines, newest first
- EdarbiBrand page: products, maker and price
- Heart failureCondition named on the label: hospitals that treat it
- High blood pressureCondition named on the label: hospitals that treat it
- StrokeCondition named on the label: hospitals that treat it
- Wilshire Pharmaceuticals, Inc.Maker or distributor
- Lupin Pharmaceuticals, Inc.Maker or distributor
- Azurity Pharmaceuticals, Inc.Maker or distributor
- All prescription drugs A to ZSearch by generic, brand or Spanish name
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Azilsartan Medoxomil, Wilshire Pharmaceuticals, Inc., effective April 20, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →