Daxxify Side Effects
Generic name: daxibotulinumtoxinA
Medically reviewed by Drugs.com. Last updated on Nov 12, 2024.
Note: This document provides detailed information about Daxxify Side Effects associated with daxibotulinumtoxinA. Some dosage forms listed on this page may not apply specifically to the brand name Daxxify.
Applies to daxibotulinumtoxinA: intramuscular powder for solution.
Important warnings
This medicine can cause some serious health issues
Intramuscular route (powder for solution)
The effects of all botulinum toxin products, including daxibotulinumtoxinA-lanm, may spread from the area of injection to produce symptoms consistent with botulinum toxin effects.
These symptoms have been reported hours to weeks after injection.
Swallowing and breathing difficulties can be life threatening and there have been reports of death.
The risk of symptoms is probably greatest in children treated for spasticity, an unapproved use for daxibotulinumtoxinA-lanm, but symptoms can also occur in adults, particularly in those patients who have an underlying condition that would predispose them to these symptoms
Precautions
It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it. Blood tests may be needed to check for unwanted effects.
Serious muscle reactions have occurred within hours to weeks after receiving this medicine. If you start to have muscle weakness, loss of bladder control, or trouble with swallowing, talking, or breathing, call your doctor right away. In some patients, these problems could be life-threatening and may require an immediate treatment in a hospital or clinic.
This medicine may cause serious allergic reaction, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a chest tightness, cough, difficulty swallowing, dizziness, fast heartbeat, hives, itching, or skin rash, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue, or unusual tiredness while you are receiving this medicine.
This medicine may increase the risks of heart rhythm problems (eg, arrhythmia) or heart attack. These are more likely to occur if you have heart or blood vessel disease. Check with your doctor right away if you have dizziness, fainting, fast, slow, or irregular heartbeat, chest pain or discomfort, pain or discomfort in the arms, jaw, back or neck, trouble breathing, nausea, or vomiting.
This medicine may reduce blinking of the eye, tear production, and cornea problems. Check with your doctor right away if blurred vision, eye irritation, increased sensitivity of the eyes to sunlight, or any other change in vision occurs during or after treatment. Your doctor may want your eyes be checked by an ophthalmologist (eye doctor).
This medicine may cause eye or vision problems, loss of strength, or muscle weakness. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Common side effects of Daxxify
Some side effects of daxibotulinumtoxinA may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common side effects
- bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
- headache
Incidence not known
- redness of the skin
Serious side effects of Daxxify
Along with its needed effects, daxibotulinumtoxinA (the active ingredient contained in Daxxify) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur while taking daxibotulinumtoxinA:
Less common side effects
- drooping upper eyelids
- partial or slight paralysis of the face
Incidence not known
- blurred vision
- change in color vision
- change in patterns and rhythms of speech
- chest pain, discomfort, or tightness
- cough
- difficulty seeing at night
- difficulty swallowing
- dizziness
- double vision
- dry eye
- eye irritation
- fainting
- fast, slow, or irregular heartbeat
- feeling of discomfort
- fever
- hives, itching, or skin rash
- hoarseness
- increased sensitivity of the eyes to sunlight
- infection from breathing foreign substance into the lungs
- joint inflammation
- loss of bladder control
- muscle aches and weakness
- nausea
- pain or discomfort in the arms, jaw, back, or neck
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- seeing double
- slurred speech
- sore throat
- sweating
- swollen lymph glands
- trouble breathing
- trouble in speaking
- voice changes
- vomiting
For healthcare professionals
Applies to daxibotulinumtoxinA: intramuscular powder for injection.
General adverse events
The most frequently reported side effects included injection site reactions, headache, eyelid ptosis, facial paresis, muscular weakness, and upper respiratory tract infection.[Ref]
Cardiovascular
- Common (1% to 10%): Atrioventricular block (First degree)
- Frequency not reported: Cardiovascular system adverse reactions[Ref]
Cardiovascular system adverse reactions included arrhythmias and myocardial infarction.[Ref]
Dermatologic
Gastrointestinal
Genitourinary
- Common (1% to 10%): Urinary tract infection[Ref]
Immunologic
- Common (1% to 10%): Anti-drug antibodies[Ref]
Treatment emergent binding antibodies were reported to be developed against this drug and RTP004 (amino acid excipient).
Two individuals who previously had botulinum toxin treatment tested positive for neutralizing antibodies.[Ref]
Local
- Common (1% to 10%): Injection site reactions[Ref]
Injection site reactions included injection site pain, injection site erythema, injection site edema, injection site bruising, injection site hematoma, injection site papule, and injection site pruritus.[Ref]
Musculoskeletal
- Common (1% to 10%): Muscular weakness, musculoskeletal pain, arthralgia, spinal pain[Ref]
Nervous system
- Common (1% to 10%): Facial paresis, headache
- Frequency not reported: Neuromuscular compromise[Ref]
Facial paresis includes facial asymmetry.[Ref]
Ocular
- Common (1% to 10%): Eyelid ptosis
- Frequency not reported: Ophthalmic adverse reactions[Ref]
Ophthalmic adverse reactions included dry eye (eye irritation, photophobia, or visual changes).[Ref]
Other
- Common (1% to 10%): Edema
- Frequency not reported: Spread of toxin effect[Ref]
Spread of toxin effect included asthenia, generalized muscle weakness, diplopia, blurred vision, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, and breathing difficulties.[Ref]
Respiratory
- Common (1% to 10%): Nasopharyngitis, upper respiratory tract infection
- Frequency not reported: Breathing difficulties[Ref]
Hypersensitivity
- Frequency not reported: Hypersensitivity reactions[Ref]
Hypersensitivity reactions included anaphylaxis, serum sickness, urticaria, soft tissue edema, and dyspnea.[Ref]
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References
1. (2022) "Product Information. Daxxify (daxibotulinumtoxinA)." Revance Therapeutics, Inc., 1
Frequently asked questions
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Further information
Daxxify side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.