Many medications can cause side effects. A side effect is an unwanted response to a medication when it is used 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 Azarga. If you are concerned about side effects, discuss the risks and benefits of Azarga with your doctor.

The following side effects have been reported by at least 1% of people using this medication. 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.

• blurred vision
• eye discomfort, dryness, redness
• feeling of something in the eye
• increased tear production
• sensitivity to light
• taste changes

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:

• coughing, shortness of breath, troubled breathing, tightness in the chest, or wheezing
• decreased blood pressure
• dizziness
• eye pain
• itching or swelling of the eye
• lightheadedness or fainting
• skin rash
• slow heartbeat or abnormal heartbeat
• unusual tiredness or weakness

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

• peeling or blistering skin
• severe skin rash
• symptoms of a Anaphylaxis (severe allergic reaction) such as Hives, difficulty breathing, or swelling of the face or throat

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 Azarga.

Each mL of ophthalmic suspension contains 10 mg of brinzolamide, 5 mg of timolol as timolol maleate, and the preservative benzalkonium chloride 0.01%. Nonmedicinal ingredients: carbomer 974P, edetate disodium, mannitol, purified water, sodium chloride, sodium hydroxide and/or hydrochloric acid (to adjust pH), and tyloxapol.

Do not use brinzolamide - timolol if you:

• are allergic to brinzolamide, timolol, other beta-blockers (e.g., Metoprolol, Atenolol), sulfonamides (e.g., sulfamethoxazole), or any of the ingredients of the medication
• have an extremely slow heart rate, second- or third-degree heart block, heart failure, or shock due to heart-related causes
• have Asthma or severe COPD (Chronic Obstructive Pulmonary Disease) (e.g., chronic Bronchitis, emphysema)
• have hyper-reactive airways
• have severe Allergic Rhinitis
• have severely reduced kidney function
• have too much acidity in the blood (called hyperchloremic acidosis)

There may be an interaction between brinzolamide - timolol and any of the following:

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 Azarga. 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 Azarga.

Allergies: Brinzolamide belongs to the family of medications known as sulfonamides or "sulfas." The same type of allergic reaction can occur with Azarga as with other sulfonamides. Contact your doctor if you experience a skin rash while using Azarga. Stop using Azarga and get medical attention if you experience hives; shortness of breath; peeling or blistering skin; or swelling of the mouth, lips, tongue, or throat.

Blurred vision: This medication can cause temporary blurred vision. Do not drive or operate machinery until your vision returns to normal.

Contact lenses: The preservative used in the eye drops (benzalkonium chloride) may be absorbed by soft contact lenses. Contact lenses should be removed before using the eye drops and not reinserted for at least 15 minutes.

Drowsiness and reduced alertness: Azarga may cause fatigue or drowsiness. Avoid driving, using machinery, or doing hazardous activities until you determine how the medication affects you.

Eye surgery, infections, trauma: If you have had eye surgery or trauma to the eye, or if you have symptoms of an eye infection (e.g., eye redness, itchiness, discharge, crusts on the eyelids, or the feeling of something in the eye), contact your doctor about further use of the eye drop.

General: As with other eye drops, this medication may be absorbed into the bloodstream. You may experience the same side effects reported with oral medications from the families known as beta-blockers (e.g., timolol, Propranolol, metoprolol), carbonic anhydrase inhibitors (e.g., Acetazolamide, Methazolamide), or sulfonamides (e.g., sulfamethoxazole). These side effects may include, but are not limited to, shortness of breath, dizziness, lightheadedness, rash, or slow heartbeat. Refer to the section, "What side effects are possible with this medication?" for more information.

Heart problems: People with heart failure should have their condition controlled before starting this medication. People with severe heart disease should discuss with their doctor whether any special monitoring is needed. Azarga may make Angina (chest pains) worse. If you have angina, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Azarga, and whether any special monitoring is needed.

Liver function: If you have reduced liver function, discuss with your doctor how Azarga may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Azarga, and whether any special monitoring is needed.

Low blood sugar: If you are prone to low blood sugar or have Diabetes, monitor your blood sugar closely while taking Azarga, as it may mask the signs of low blood sugar.

Muscle weakness: Beta-blockers such as timolol have been reported to increase muscle weakness associated with certain conditions, such as Myasthenia Gravis. If you experience symptoms of muscle weakness, contact your doctor.

Pregnancy: Azarga should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while using Azarga, contact your doctor immediately.

Breast-feeding: It is not known if brinzolamide passes into breast milk. Timolol does pass into breast milk. If you are a breast-feeding mother and are using Azarga, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Azarga have not been established for children.