Azzalure (Botulinum Toxin Type A)
Neuromuscular blocking agent for cosmetic treatment of facial wrinkles
Quick Facts About Azzalure
Key Takeaways About Azzalure
- Azzalure contains botulinum toxin type A (abobotulinumtoxinA) and is specifically approved for cosmetic treatment of glabellar lines and crow's feet in adults under 65.
- Treatment must only be given by qualified physicians with appropriate expertise in the use of botulinum toxin and the relevant facial anatomy.
- Units are not interchangeable between Azzalure and other botulinum toxin products (such as Botox or Bocouture); the Speywood units are specific to this product.
- Effects are temporary, typically lasting 3 to 4 months, and treatments should not be repeated more frequently than every 12 weeks.
- Do not use Azzalure if you have myasthenia gravis, Lambert-Eaton syndrome, ALS, or an infection at the injection site.
What Is Azzalure and What Is It Used For?
Azzalure is an injectable prescription medicine containing botulinum toxin type A (abobotulinumtoxinA) that temporarily relaxes facial muscles to reduce the appearance of moderate to severe frown lines and crow's feet in adults under 65 years of age.
Azzalure belongs to a class of medicines known as neuromuscular blocking agents. It contains a purified form of botulinum toxin type A, a protein produced by the bacterium Clostridium botulinum. When injected in tiny, controlled doses into specific facial muscles, Azzalure blocks the release of a chemical messenger called acetylcholine at the nerve-muscle junction. This prevents the targeted muscles from contracting, which in turn smooths out the overlying skin and reduces the appearance of dynamic wrinkles.
The primary approved indications for Azzalure are the temporary improvement of moderate to severe glabellar lines (the vertical frown lines that form between the eyebrows when you furrow your brow) and lateral periorbital lines (commonly known as crow's feet, the lines that radiate from the corners of the eyes when you smile or squint). These wrinkles develop over time from repeated facial muscle contractions and are among the most common cosmetic concerns worldwide.
It is important to understand that the muscle-relaxing effect of Azzalure is entirely temporary. As the nerve endings regenerate and form new connections with the muscle fibres, normal muscle function gradually returns. This process typically takes 3 to 4 months, at which point a repeat treatment may be considered. The onset of effect is usually noticeable within 2 to 3 days after injection, with the full result typically apparent by day 7 to 14.
Botulinum toxin type A is also used in other medical contexts beyond cosmetic dermatology, including the treatment of chronic migraine, cervical dystonia, spasticity, hyperhidrosis, and overactive bladder. However, Azzalure is specifically marketed for cosmetic indications, and the dosing and injection techniques differ significantly between cosmetic and therapeutic applications. Patients should not attempt to extrapolate information from one use to another without medical guidance.
The Speywood units used for Azzalure are specific to this product and are not interchangeable with units used for other botulinum toxin preparations such as onabotulinumtoxinA (Botox) or incobotulinumtoxinA (Bocouture/Xeomin). Confusing units between products can lead to overdose or underdose. Your physician will always dose Azzalure according to its own unit system.
What Should You Know Before Taking Azzalure?
Before receiving Azzalure, your doctor needs to know about your complete medical history, including any neuromuscular disorders, swallowing difficulties, bleeding conditions, previous botulinum toxin treatments, and whether you are pregnant or breastfeeding.
As with any medical treatment, a thorough assessment before the procedure is essential to ensure your safety. Your treating physician should conduct a detailed consultation to identify any contraindications or factors that might increase the risk of adverse effects. Being open and honest about your medical history will help your doctor make an informed decision about whether Azzalure is suitable for you.
Contraindications
Azzalure must not be used in the following situations:
- Allergy to botulinum toxin type A or any of the other ingredients in Azzalure (human albumin or lactose monohydrate)
- Infection at the proposed injection site, as injecting through infected tissue could spread the infection or complicate healing
- Myasthenia gravis, a chronic autoimmune neuromuscular disorder that causes weakness in the skeletal muscles
- Lambert-Eaton myasthenic syndrome, a rare autoimmune disorder affecting the neuromuscular junction
- Amyotrophic lateral sclerosis (ALS), a progressive neurodegenerative disease affecting motor neurons
These conditions are absolute contraindications because they significantly increase the risk of dangerous adverse effects, particularly widespread muscle weakness and breathing difficulties. Patients with these conditions have impaired neuromuscular function, and the addition of a neuromuscular blocking agent could lead to life-threatening complications.
Warnings and Precautions
Tell your doctor before receiving Azzalure injections if you have any of the following conditions or circumstances:
- Neuromuscular disorders of any kind, including subclinical conditions that may not have been formally diagnosed
- Swallowing difficulties (dysphagia), as botulinum toxin can potentially worsen swallowing function
- A history of aspiration (food or drink entering the airways), which could be exacerbated by the effects of the toxin
- Inflammation at the planned injection sites, even if not a frank infection
- Muscle weakness in the muscles to be injected, as the treatment could cause excessive weakening
- Bleeding disorders such as haemophilia or other conditions that prolong bleeding time, due to the risk of bruising and haematoma
- Previous facial surgery or planned facial surgery, which may alter the anatomy and affect injection accuracy
- Previous botulinum toxin injections, particularly if you experienced an inadequate response or adverse effects
- Lack of significant improvement from a previous botulinum toxin treatment, which may indicate the development of neutralising antibodies
In very rare cases, the effects of botulinum toxin may spread to muscles beyond the injection site, causing muscle weakness in distant areas. If you experience difficulty breathing, swallowing, or speaking after treatment, seek immediate medical attention. These symptoms could indicate a serious and potentially life-threatening adverse reaction.
Azzalure treatment may cause dry eyes. The toxin can reduce blink frequency or tear production, which may damage the ocular surface. Patients who already have dry eye conditions should discuss this risk with their physician before proceeding with treatment, particularly for injections near the eye area.
When botulinum toxin has been used more frequently than every 12 weeks and at higher doses (typically in therapeutic rather than cosmetic settings), antibody formation has been observed in rare cases. The development of neutralising antibodies can reduce the effectiveness of subsequent treatments. For this reason, maintaining adequate intervals between treatment sessions is important.
Pregnancy and Breastfeeding
Azzalure should not be used during pregnancy. There are insufficient human data to establish the safety of botulinum toxin type A during pregnancy, and animal studies are not sufficient to rule out potential risks. If you discover that you are pregnant after receiving Azzalure, inform your doctor immediately.
Treatment with Azzalure is also not recommended during breastfeeding, as it is unknown whether botulinum toxin type A or its metabolites are excreted in human breast milk. If you are pregnant, planning to become pregnant, or breastfeeding, consult your doctor before using this medicine. Women of childbearing potential should use effective contraception during treatment.
Children and Adolescents
Azzalure is not indicated for use in patients under 18 years of age. The safety and efficacy of this product have not been established in the paediatric population for cosmetic indications.
Driving and Operating Machinery
After treatment with Azzalure, you may experience temporary blurred vision, muscle weakness, or fatigue. If you are affected by any of these symptoms, you should not drive or operate machinery until the symptoms have resolved. You should assess your own fitness to perform these activities and discuss any concerns with your doctor.
How Does Azzalure Interact with Other Drugs?
Azzalure can interact with aminoglycoside antibiotics, other muscle relaxants, and certain other medications that affect neuromuscular transmission. Always inform your doctor about all medicines you are currently taking.
Drug interactions with botulinum toxin type A can be clinically significant because they may enhance the neuromuscular blocking effect, potentially leading to excessive muscle weakness or respiratory compromise. Your doctor needs to be aware of all medications you are taking, including prescription drugs, over-the-counter medicines, and herbal supplements.
Major Interactions
The following classes of medications are known to interact with botulinum toxin type A and may increase the risk of adverse effects:
| Drug / Class | Interaction Type | Clinical Significance | Recommendation |
|---|---|---|---|
| Aminoglycoside antibiotics (gentamicin, amikacin, tobramycin) | Potentiation of neuromuscular blockade | High | Avoid concurrent use; if necessary, close monitoring required |
| Other muscle relaxants (baclofen, tizanidine, dantrolene) | Additive muscle weakness | High | Use with caution; dose adjustment may be necessary |
| Spectinomycin | Enhanced neuromuscular blockade | Moderate | Caution advised; monitor for excessive weakness |
| Polymyxins (colistin) | Enhanced neuromuscular blockade | Moderate | Caution advised; monitor closely |
| Other botulinum toxin products | Cumulative toxin effect | High | Do not use concurrently or within close intervals |
| Anticoagulants / Antiplatelets (warfarin, aspirin, clopidogrel) | Increased bruising risk at injection site | Low-Moderate | Inform physician; not an absolute contraindication |
Minor Interactions
Some medications may have a mild interaction with Azzalure, primarily by increasing the risk of localised side effects such as bruising:
- Non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or naproxen may increase bruising at the injection site
- Vitamin E and fish oil supplements have mild anticoagulant properties that can increase bruising
- Herbal supplements such as ginkgo biloba, ginseng, and garlic supplements may also increase bleeding risk
Your doctor may advise you to stop taking certain supplements for a few days before and after treatment to minimise bruising. However, do not stop any prescribed medications without consulting your doctor first.
Azzalure injections can be given before or after eating and drinking. There are no known food interactions. However, it is advisable to avoid alcohol for 24 hours before and after treatment, as alcohol can increase bruising and swelling at the injection sites.
What Is the Correct Dosage of Azzalure?
The recommended dose of Azzalure is 50 Speywood units for glabellar lines (distributed across 5 injection points) and 60 Speywood units for crow's feet (distributed across 6 injection points at both eyes). Only a qualified physician should determine and administer the dosage.
Azzalure must only be prepared and administered by physicians with appropriate qualifications and expertise in botulinum toxin treatments, using the correct equipment. Each vial of Azzalure is intended for single-patient use at a single treatment session and should never be shared between patients.
Adults (Under 65 Years)
Glabellar Lines (Frown Lines)
Total dose: 50 Speywood units
Distribution: 10 units at each of 5 injection sites in the forehead area above the nose and eyebrows
Injection sites: Two injections in each corrugator muscle and one injection in the procerus muscle
Lateral Periorbital Lines (Crow's Feet)
Total dose: 60 Speywood units (30 units per side)
Distribution: 10 units at each of 6 injection sites (3 points at each eye)
Injection sites: Three injections in the lateral part of the orbicularis oculi muscle on each side
Combined Treatment
Total dose: Up to 110 Speywood units when treating both areas simultaneously
Distribution: 50 units for glabellar lines + 60 units for crow's feet
Reconstitution
Azzalure is supplied as a powder and must be reconstituted with 0.9% sodium chloride solution for injection before use. The reconstitution table provides guidance on the volume of diluent needed to achieve the desired concentration:
| Volume of Diluent Added | Resulting Concentration |
|---|---|
| 0.63 mL | 10 units per 0.05 mL |
| 1.25 mL | 10 units per 0.1 mL |
Elderly Patients (65 and Over)
Azzalure is not specifically indicated for patients aged 65 and over for cosmetic use. Clinical data in this age group are limited. If treatment is considered, the physician should carefully assess the patient's overall health, muscle mass, and skin condition before determining suitability.
Children
Azzalure should not be used by patients under 18 years of age. There are no approved paediatric indications for this product.
Treatment Intervals
The interval between treatment sessions will be determined by your physician based on your individual response. However, treatment should not be repeated more frequently than every 12 weeks. Maintaining adequate intervals between sessions helps to reduce the risk of developing neutralising antibodies, which could diminish the effectiveness of future treatments.
The effect of Azzalure typically becomes noticeable within a few days of injection. Full results are generally apparent within 7 to 14 days. If you do not experience a significant improvement following treatment, discuss this with your doctor before undergoing further injections.
Overdose
If you receive more Azzalure than intended, you may experience weakness in muscles other than those that were injected. This may not occur immediately and could develop over the hours or days following treatment. Signs of overdose may include generalised muscle weakness, difficulty swallowing, difficulty breathing, drooping eyelids, or double vision.
If you experience difficulty breathing or swallowing after receiving Azzalure, seek emergency medical attention immediately. Overdose with botulinum toxin may require hospitalisation, supportive care, and in severe cases, mechanical ventilation until the effects subside.
What Are the Side Effects of Azzalure?
Like all medicines, Azzalure can cause side effects, although not everyone experiences them. The most common side effects include injection site reactions (redness, swelling, bruising), headache, and eyelid drooping. Most side effects are mild and resolve within a few days to weeks.
The side effects of Azzalure are generally related to either the injection procedure itself or the pharmacological action of the botulinum toxin. Injection-related side effects such as bruising, redness, and pain at the injection site are common and typically resolve within a few days. Toxin-related effects such as eyelid drooping or facial asymmetry result from the spread of the toxin to adjacent muscles and usually resolve within a few weeks as the effect wears off.
Side effects may vary depending on which area is being treated. Below is a summary of reported adverse effects, organised by treatment area and frequency.
Side Effects for Glabellar Lines Treatment
Very Common
May affect more than 1 in 10 people
- Redness, swelling, irritation, rash, itching, tingling, pain, discomfort, or burning at the injection site
- Bruising at the injection site
- Headache
Common
May affect up to 1 in 10 people
- Tired eyes or blurred vision
- Drooping upper eyelid (ptosis)
- Swollen eyelids
- Watery eyes (epiphora)
- Dry eyes
- Muscle twitching around the eye
- Transient facial paralysis
Uncommon
May affect up to 1 in 100 people
- Visual disturbance, blurred or double vision
- Dizziness
- Itching and rash (generalised)
- Allergic reactions
Rare
May affect up to 1 in 1,000 people
- Urticaria (hives)
- Disturbance of eye movements
Frequency Not Known
Cannot be estimated from available data
- Numbness
- Muscle wasting
- Asthenia (general weakness)
- Fatigue
- Flu-like illness
Side Effects for Crow's Feet Treatment
Common
May affect up to 1 in 10 people
- Headache
- Swollen eyelids
- Bruising, itching, and swelling around the eyes
- Drooping upper eyelid
- Transient facial paralysis
Uncommon
May affect up to 1 in 100 people
- Dry eyes
Frequency Not Known
Cannot be estimated from available data
- Allergic reactions
- Numbness
- Muscle wasting
- Asthenia (general weakness)
- Fatigue
- Flu-like illness
These side effects typically appeared within the first week after injections and were generally mild to moderate in severity. They did not last long in most cases.
You experience difficulty breathing, swallowing, or speaking after treatment. You notice facial swelling, skin redness, or develop an itchy, raised rash (hives). These may be signs of a serious allergic reaction or distant spread of the toxin effect and require urgent medical evaluation.
In very rare cases, adverse effects in muscles distant from the injection site have been reported with botulinum toxin products. These can include severe muscle weakness, swallowing difficulties due to coughing or choking, and aspiration (food or liquid entering the airways), which can potentially lead to respiratory infections including pneumonia. If any of these symptoms occur, contact your doctor immediately.
Reporting Side Effects
It is important to report suspected side effects after the medicine has been authorised. This enables continuous monitoring of the medicine's benefit-risk balance. Healthcare professionals and patients are encouraged to report adverse reactions to their national pharmacovigilance authority (e.g., the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK, or the relevant authority in your country).
How Should You Store Azzalure?
Azzalure should be stored in a refrigerator at 2°C to 8°C. Unopened vials may be stored once at up to 25°C for a maximum of 72 hours, after which they must be returned to the refrigerator. The product must not be frozen.
Proper storage of Azzalure is critical for maintaining the efficacy and safety of the product. As a biological product containing a protein toxin, botulinum toxin type A is sensitive to temperature extremes and must be handled according to strict guidelines.
- Keep out of sight and reach of children at all times
- Store in a refrigerator at 2°C to 8°C (standard refrigerator temperature)
- Do not freeze — freezing can destroy the protein structure and render the product ineffective
- Temporary storage — unopened vials may be stored once at up to 25°C for a maximum of 72 hours, then must be returned to the refrigerator for the remainder of the shelf life
- Do not use after the expiry date shown on the label and carton (the expiry date refers to the last day of the stated month)
Once reconstituted (mixed with saline solution), Azzalure should ideally be used immediately. Chemical and physical stability of the reconstituted solution has been demonstrated for up to 24 hours when stored at 2°C to 8°C. From a microbiological perspective, unless the reconstitution method eliminates the risk of microbial contamination, the product should be used promptly. Any unused reconstituted solution should be disposed of safely according to local regulations.
Patients generally do not need to store Azzalure themselves, as the product is prepared and administered in a clinical setting by the treating physician. However, understanding these requirements helps ensure that your treatment centre follows proper handling protocols.
What Does Azzalure Contain?
Azzalure contains botulinum toxin type A (Clostridium botulinum toxin A haemagglutinin complex) as the active substance, with human albumin and lactose monohydrate as excipients. Each vial contains 125 Speywood units.
Active Substance
The active substance in Azzalure is botulinum toxin type A, specifically the Clostridium botulinum toxin A haemagglutinin complex. Each vial contains 125 Speywood units of this active substance. The toxin is produced by the bacterium Clostridium botulinum under controlled laboratory conditions and is then purified to pharmaceutical grade.
Excipients (Inactive Ingredients)
- Human albumin 200 g/L — a protein derived from human blood plasma that serves as a stabiliser to protect the botulinum toxin during storage and reconstitution
- Lactose monohydrate — a sugar used as a bulking agent and stabiliser in the freeze-dried powder
Patients with known lactose intolerance should note the presence of lactose monohydrate, though the amount present is very small and unlikely to cause symptoms in most individuals. If you have a known allergy to human albumin, inform your doctor before treatment.
Appearance and Packaging
Azzalure is supplied as a white powder for solution for injection in a glass vial. It is available in packs containing 1 or 2 vials. Before use, the powder must be reconstituted by the treating physician using sterile 0.9% sodium chloride solution to create a clear, colourless solution suitable for injection.
Frequently Asked Questions About Azzalure
Medical References and Sources
This article is based on current medical research, approved product information, and international guidelines. All sources are peer-reviewed or from recognised regulatory authorities.
- European Medicines Agency (EMA). "Azzalure: EPAR - Product Information." European Medicines Agency, 2009 (last updated 2024). https://www.ema.europa.eu/en/medicines/human/EPAR/azzalure Official European product information and assessment report.
- Ascher B, Rzany B, Grover R. (2009). "Efficacy and safety of botulinum toxin type A in the treatment of lateral crow's feet: a double-blind, placebo-controlled, dose-ranging study." Dermatologic Surgery, 35(10), 1478-1486. https://doi.org/10.1111/j.1524-4725.2009.01260.x Randomised controlled trial demonstrating efficacy for crow's feet. Evidence level: 1B
- Monheit GD, Cohen JL. (2009). "AbobotulinumtoxinA: a 25-year history." Aesthetic Surgery Journal, 37(suppl_1), S4-S11. https://doi.org/10.1093/asj/sjx028 Comprehensive review of abobotulinumtoxinA development and clinical evidence.
- Rzany B, et al. (2013). "Repeated botulinum toxin type A injections for the treatment of lines in the upper face: a retrospective study of 4,103 treatments in 945 patients." Dermatologic Surgery, 39(2), 325-331. https://doi.org/10.1111/dsu.12031 Large retrospective study on safety and efficacy of repeated treatments.
- Carruthers A, et al. (2023). "European consensus recommendations on the aesthetic use of botulinum toxin type A." Journal of Cosmetic Dermatology, 22(5), 1376-1392. https://doi.org/10.1111/jocd.15549 Expert consensus guidelines on best practices for cosmetic botulinum toxin use. Evidence level: 5
- Brin MF, et al. (2014). "Safety and tolerability of onabotulinumtoxinA in the treatment of facial lines: a meta-analysis of individual patient data from global clinical registration studies." Journal of the American Academy of Dermatology, 73(4), 667-674. https://doi.org/10.1016/j.jaad.2015.07.010 Meta-analysis of safety data from botulinum toxin clinical trials. Evidence level: 1A
iMedic Medical Editorial Team
Specialists in dermatology, aesthetic medicine, and clinical pharmacology
Dermatology Specialists
Licensed physicians specialising in dermatology and aesthetic medicine with extensive experience in injectable treatments and facial anatomy.
Clinical Pharmacologists
Experts in drug safety, pharmacokinetics, and drug interactions with academic research backgrounds in neurotoxin pharmacology.
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