Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes Edarbi (Azilsartan-medoxomil). If you are concerned about side effects, discuss the risks and benefits of Edarbi (Azilsartan-medoxomil) with your doctor.

The following side effects have been reported by at least 1% of people taking Edarbi (Azilsartan-medoxomil). Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• Diarrhea
• dizziness
• drowsiness
• fatigue
• headache
• muscle pain or spasms
• nausea
• rash
• trouble sleeping
• vomiting

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• irregular, rapid, or pounding heart beat
• lightheadedness or dizziness when rising from a sitting or lying position
• signs of bleeding (e.g., nosebleeds, blood in urine, coughing blood, bleeding gums, unusual bruising or bleeding)
• signs of kidney problems (e.g., decreased urination, nausea, vomiting, swelling of the feet and ankles)
• signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
• signs of muscle damage (e.g., muscle pain, tenderness or weakness, or brown or discoloured urine)
• swelling of the ankles, feet or hands
• symptoms of too much potassium in the body (e.g., muscle fatigue, weakness, difficulty moving, abnormal heart rhythms, nausea)
• symptoms of a urinary tract infection (e.g., pain when urinating, urinating more often than usual, low back or flank pain)

Stop taking the medication and seek immediate medical attention if any of the following occur:

• signs of a serious allergic reaction (e.g., swelling of face or throat, Hives, or difficulty breathing)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking Edarbi (Azilsartan-medoxomil).

40 mg
Each white to nearly white round tablet debossed "ASL" on one side and "40" on the other contains 42.68 mg of azilsartan medoxomil potassium, which is equivalent to 40 mg of azilsartan medoxomil. Nonmedicinal ingredients: mannitol, fumaric acid, sodium hydroxide, hydroxypropyl cellulose, croscarmellose sodium, microcrystalline cellulose, and magnesium stearate.

80 mg
Each white to nearly white round tablet debossed "ASL" on one side and "80" on the other contains 85.36 mg of azilsartan medoxomil potassium, which is equivalent to 80 mg of azilsartan medoxomil. Nonmedicinal ingredients: mannitol, fumaric acid, sodium hydroxide, hydroxypropyl cellulose, croscarmellose sodium, microcrystalline cellulose, and magnesium stearate.

Do not take azilsartan if you:

• are allergic to azilsartan or any ingredients of the medication
• are taking Aliskiren and have Diabetes or moderately to severely decreased kidney function
• are or may be pregnant
• are breast-feeding

There may be an interaction between azilsartan and any of the following:

• aliskiren
• alpha blockers (e.g., Alfuzosin, Doxazosin, Tamsulosin)
• alpha agonists (e.g., Clonidine, methyldopa)
• amifostine
• Amiodarone
• amphetamines (e.g., Dextroamphetamine, lisdexamphetamine)
• angiotensin converting enzyme inhibitors (ACEIs; e.g., Captopril, Lisinopril, Ramipril)
• barbiturates (e.g., butalbital, pentobarbital Phenobarbital)
• beta-adrenergic blockers (e.g., Atenolol, Propranolol, Sotalol)
• brimonidine
• calcium channel blockers (e.g., Amlodipine, diltiazem, nifedipine, verapamil)
• Canagliflozin
• Celecoxib
• certain  anti-psychotics (e.g., Clozapine, Olanzapine, Quetiapine, Risperidone)
• ciprofloxacin
• conivaptan
• Cyclosporine
• Dapagliflozin
• diuretics (water pills; e.g., Furosemide, hydrochlorothiazide, triamterene)
• drospirenone
• Duloxetine
• Guanfacine
• Hydralazine
• Heparin
• levodopa
• lithium
• low molecular weight heparins (e.g., Dalteparin, Enoxaparin, Tinzaparin)mannitol
• Methylphenidate
• monoamine oxidase inhibitors (M.O.S. e.g., Moclobemide, Phenelzine, Rasagiline, Selegiline, Tranylcypromine)
• Minoxidil
• nitrates (e.g., Nitroglycerin, isosorbide dinitrate, isosorbide mononitrate)
• non-steroidal anti-inflammatory medications (NSAIDs; e.g., Diclofenac, Ibuprofen, Naproxen)
• other angiotensin receptor blockers (ARBs; e.g., candasartan, Irbesartan, Losartan)
• Pentoxifylline
• phosphodiesterase 5 inhibitors (e.g., Sildenafil, Tadalafil, Vardenafil)
• potassium supplements
• quetiapine
• quinine
• Rituximab
• Ropinirole
• sacubitril
• sodium phosphates
• Tizanidine
• tolcapone
• Tolvaptan
• Trimethoprim
• Yohimbine

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Edarbi (Azilsartan-medoxomil). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Edarbi (Azilsartan-medoxomil).

Allergy: People who have had an allergic reaction to other ARBs are advised not to take azilsartan. Before you take azilsartan, inform your doctor about any previous adverse reactions you have had to medications. Contact your doctor at once if you experience signs of an allergic reaction such as skin rash, itching, difficulty breathing, or swelling of the face and throat.

Kidney problems: Azilsartan may affect the function of the kidneys, especially for those people who already have kidney problems. Taking diuretics (water pills) such as aliskiren or nonsteroidal anti-inflammatory drugs (NSAIDs) such as Asa (Aspirin) may further increase the risk of kidney problems. If you have reduced kidney function, Kidney Disease, or renal artery stenosis (narrowing of blood vessels in the kidneys), discuss with your doctor how Edarbi (Azilsartan-medoxomil) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Edarbi (Azilsartan-medoxomil), and whether any special monitoring is needed.

Liver function: Liver disease or reduced liver function may cause Edarbi (Azilsartan-medoxomil) to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how Edarbi (Azilsartan-medoxomil) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Edarbi (Azilsartan-medoxomil), and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking Edarbi (Azilsartan-medoxomil).

Low Blood Pressure: Occasionally, a larger-than-expected decrease in blood pressure occurs after taking azilsartan. In some cases, this happens after the first dose. It is more likely to occur if you take diuretics (water pills) such as aliskiren, have a reduced salt intake, are on dialysis, or are experiencing diarrhea or vomiting. Blood pressure should be monitored more often in these situations. If you have low blood pressure, are just starting Edarbi (Azilsartan-medoxomil) or are increasing the dose, move slowly from a reclining to an upright position to reduce the risk of dizziness.

Pregnancy: Azilsartan should not be taken by pregnant women as it can cause harm to an unborn child. If you are planning to become pregnant, discuss alternative medications for blood pressure control with your doctor. If you become pregnant while taking Edarbi (Azilsartan-medoxomil), stop taking it and tell your doctor at once.

Breast-feeding: It is not known if azilsartan passes into breast milk. If you are a breast-feeding mother and are taking Edarbi (Azilsartan-medoxomil), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of Edarbi (Azilsartan-medoxomil) have not been established for children.

Seniors: Seniors may be at increased risk of experiencing low blood pressure from Edarbi (Azilsartan-medoxomil).