Safety + Side Effects + Authentic Dysport®

Identifying authentic Dysport

There’s only one FDA-approved Dysport. It’s important to find a primary care physician, dermatologist, cosmetic aesthetician, plastic surgeon or other healthcare professional who is trained and licensed to administer Dysport.

Galderma provides comprehensive training for all qualified healthcare providers who want to inject our aesthetic products. Be sure to ask your specialist to see the packaging of your product to make sure it’s authentic.

There are more anti-counterfeiting measures on the packaging that aren’t listed here. Ask your specialist to verify the Dysport you’re being treated with is authentic.

Find a specialist who uses authentic Dysport in your area.

Common side effects

When it comes to possible side effects, you may be wondering why Dysport has a boxed warning. In 2009, following a comprehensive safety review, the FDA mandated that all botulinum toxins — including Dysport — carry a boxed warning to bring attention to the fact that these products have the potential to spread from the injection site to other parts of the body, resulting in serious risks, including difficulty talking, swallowing or breathing; muscle weakness; drooping eyelids; and blurred or double vision.

However, the most common possible side effects include:

Other side effects

Dysport may cause serious side effects that can be life threatening, including:

  • Problems breathing or swallowing — People who already have swallowing or breathing problems before receiving Dysport have the highest risk of getting these problems. These problems can happen within hours, or days to weeks after an injection of Dysport, usually because the muscles used to breathe and swallow can become weak after the injection. Death can happen as a complication if you have severe problems with swallowing or breathing after treatment with Dysport.
    • People with certain breathing problems may need to use muscles in their neck to help them breathe. These patients may be at greater risk for serious breathing problems with Dysport.
    • Swallowing problems may last for several weeks. People who can not swallow well may need a feeding tube to receive food and water. If swallowing problems are severe, food or liquids may go into your lungs.
  • Spread of toxin effects — In some cases, the effect of botulinum toxin may affect areas of the body away from the injection site and cause symptoms of a serious condition called botulism. The symptoms of botulism include:
    • loss of strength and muscle weakness all over the body
    • double vision
    • blurred vision and drooping eyelids
    • hoarseness or change or loss of voice (dysphonia)
    • trouble saying words clearly (dysarthria)
    • loss of bladder control
    • trouble breathing
    • trouble swallowing
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IMPORTANT SAFETY INFORMATION

Dysport is a prescription injection for temporary improvement in the look of moderate to severe frown lines between the eyebrows (glabellar lines) in adults less than 65 years of age.

Important Safety Information

What is the most important information you should know about Dysport?

Spread of Toxin Effects: In some cases, the effects of Dysport and all botulinum toxin products may affect areas of the body away from the injection site. Symptoms can happen hours to weeks after injection and may include swallowing and breathing problems, loss of strength and muscle weakness all over the body, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice, trouble saying words clearly, or loss of bladder control. Swallowing and breathing problems can be life threatening and there have been reports of death. You are at the highest risk if these problems are pre-existing before injection.

These effects could make it unsafe for you to drive a car, operate machinery, or do other dangerous activities.

Do not have Dysport treatment if you: are allergic to Dysport or any of its ingredients (see the end of the Medication Guide for a list of ingredients), are allergic to cow’s milk protein, had an allergic reaction to any other botulinum toxin product, such as Myobloc®, Botox®, or Xeomin®, have a skin infection at the planned injection site, under 18 years of age, or are pregnant or breastfeeding.

The dose of Dysport is not the same as the dose of any other botulinum toxin product and cannot be compared to the dose of any other product you may have used.

Tell your doctor about any swallowing or breathing difficulties and all your muscle or nerve conditions such as amyotrophic lateral sclerosis [ALS or Lou Gehrig’s disease], myasthenia gravis, or Lambert-Eaton syndrome, which may increase the risk of serious side effects including difficulty swallowing and difficulty breathing.

Tell your doctor about all of your medical conditions, including if you have surgical changes to your face, very weak muscles in the treatment area, any abnormal facial change, injection site inflammation, droopy eyelids or sagging eyelid folds, deep facial scars, thick oily skin, wrinkles that can’t be smoothed by spreading them apart, or if you are pregnant or breastfeeding or planning to become pregnant or breastfeed.

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins and herbal and other natural products. Using Dysport with certain other medicines may cause serious side effects. Do not start any new medicines while taking Dysport without talking to your doctor first.

Especially tell your doctor if you: have received any other botulinum toxin product, such as Myobloc® (rimabotulinumtoxinB), Botox® (onabotulinumtoxinA), or Xeomin® (incobotulinumtoxinA), in the last four months or any in the past (be sure your doctor knows exactly which product you received, have recently received an antibiotic by injection, take muscle relaxants, take an allergy or cold medicine, or take a sleep medicine.

Common Side Effects

The most common side effects are nose and throat irritation, headache, injection site pain, injection site skin reaction, upper respiratory tract infection, eyelid swelling, eyelid drooping, sinus inflammation, and nausea.

Ask your doctor if Dysport is right for you.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see Dysport Full Prescribing Information including Medication Guide.