Simbrinza can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while using Simbrinza. These lists don’t include all possible side effects.

For more information on the possible side effects of Simbrinza, talk with your doctor or pharmacist. They can give you tips on how to deal with any side effects that may be bothersome.

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Note: The Food and Drug Administration (FDA) tracks side effects of drugs it has approved. If you would like to notify the FDA about a side effect you’ve had with Simbrinza, you can do so through MedWatch.

Mild side effects

Mild side effects of Simbrinza can include:*

• eye side effects, such as:
  • blurry vision
  • eye allergy
  • eye irritation
• dry mouth
• changes in how things taste

Most of these side effects may go away within a few days or a couple of weeks. But if they become more severe or don’t go away, talk with your doctor or pharmacist.

* This is a partial list of mild side effects from Simbrinza. For more information on these side effects, see “Side effect details” below. To learn about other mild side effects, talk with your doctor or pharmacist, or view Simbrinza’s prescribing information.

Serious side effects

Serious side effects from Simbrinza aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Serious side effects and their symptoms can include:

• Decreased blood pressure. Symptoms can include:
  • dizziness
  • fainting
  • nausea
  • blurry vision
• Allergic reaction.*

* For more information about this side effect, see “Side effect details” below.

Side effects in children

Simbrinza is approved for use in children ages 2 years and older. There haven’t been clinical studies on children using Simbrinza. However, Simbrinza’s active drugs (brinzolamide and brimonidine tartrate) have been studied individually in clinical trials involving children. Brinzolamide has been studied in children ages 4 weeks to 5 years, while brimonidine tartrate has been studied in children ages 2 to 7 years.

Side effects seen in children using brimonidine tartrate include:

• drowsiness
• decreased alertness

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No side effects were seen in children using brinzolamide during these trials. But this doesn’t mean side effects can’t occur in children taking this drug. Keep in mind that side effects of a drug may not be seen until the drug has been available and on the market for many years.

If you have questions about side effects that may occur in a child using Simbrinza, talk with your doctor or pharmacist.

Side effect details

You may wonder how often certain side effects occur with this drug. Here’s some detail about certain side effects this drug may cause.

Allergic reaction

As with most drugs, some people can have an allergic reaction after using Simbrinza. It’s not known how many people in clinical trials had an allergic reaction to the drug.

Symptoms of a mild allergic reaction can include:

• skin rash
• itchiness, which may affect your skin or eyes
• flushing (warmth and redness in your skin)

A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include:

• swelling under your skin, typically in your eyelids, lips, hands, or feet
• swelling of your tongue, mouth, or throat
• trouble breathing

If you’re using Simbrinza and you have a sulfa allergy, you may have an increased risk of a severe rash or a life threatening reaction. This is because one of Simbrinza’s active drugs, brinzolamide, is a sulfonamide (a “sulfa drug”). Even though Simbrinza is used topically on your eye, the drug can still cause these reactions in some people.

If you’re allergic to sulfa drugs, tell your doctor before using Simbrinza. They may recommend a medication other than Simbrinza to treat your condition.

Call your doctor right away if you have an allergic reaction to Simbrinza. But call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Eye side effects

You may develop eye side effects while you’re using Simbrinza.

In clinical trials, eye side effects occurred in about 3% to 5% of people using Simbrinza. These side effects included blurry vision, eye irritation, or eye allergy. Symptoms of eye irritation or eye allergy can include redness or itchiness in your eye.

In these trials, Simbrinza wasn’t compared with a placebo (a treatment with no active drug). So it’s not known how many people using a placebo might also have had eye side effects.

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If you have eye side effects while you’re using Simbrinza, your doctor may recommend ways to decrease your side effects. Or your doctor may recommend a medication other than Simbrinza.

Note: It’s possible that certain eye-related symptoms could occur with an allergic reaction to Simbrinza. For more information about this, see the “Allergic reaction” section above.)

Dry mouth

You may experience dry mouth while you’re using Simbrinza.

In clinical trials, dry mouth occurred in about 3% to 5% of people using the drug. In these trials, Simbrinza wasn’t compared with a placebo (treatment with no active drug). So it’s not known how many people using a placebo might also have had a dry mouth.

If you have a dry mouth while you’re using Simbrinza, your doctor may be able to recommend ways to decrease this side effect.

Changes in how things taste

Some people using Simbrinza noticed a change in their sense of taste while using the drug.

In clinical trials, about 3% to 5% of people using Simbrinza noticed change in how things tasted. In these trials, Simbrinza wasn’t compared with a placebo (treatment with no active drug). So it’s not known how many people might have had this side effect while using a placebo.

If you notice a change in how things taste while you’re using Simbrinza, your doctor may recommend ways to decrease this side effect. Or your doctor may have you use a medication other than Simbrinza to treat your condition.

Hair loss (not a side effect)

Hair loss isn’t a known side effect of Simbrinza. It wasn’t reported in clinical trials of the drug.

However, in trials of brinzolamide eye drops, hair loss was reported in less than 1% of people studied. (Brinzolamide is one of the active drugs in Simbrinza.) In these trials, brinzolamide wasn’t compared with a placebo (a treatment with no active drug). So it’s not known how many people using a placebo might also have had hair loss.

If you have hair loss that’s sudden or bothersome to you, talk with your doctor. They may recommend a different medication to treat your condition.

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Category: WHY