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      • This website is for UK Healthcare Professionals only

      This promotional material is intended for UK Healthcare Professionals only.
      BOTOX® (botulinum toxin type A) Prescribing Information and adverse event reporting information can be found below.

      Person standing indoors at a kitchen counter, working with their hands on food preparation
      Person standing indoors at a kitchen counter, working with their hands on food preparation
      Prescribing Information
      Summary of product characteristics
      Resources
      Person standing indoors at a kitchen counter, working with their hands on food preparation

      UK-BNO-250045. DOP: May 2025.

      Safety and tolerability experience from >30 years of use in a range of conditions5-7

      BOTOX® is generally well tolerated in the treatment of post-stroke spasticity (PSS)5

      In a meta-analysis of data from 37 randomised controlled trials across all indications (BOTOX® n=1,447):6

      • Adverse events (AEs) associated with BOTOX® were generally mild to moderate in severity
      • Results were consistent over long-term clinical use

      The frequency of adverse reactions reported in the clinical trials is defined as follows: Common (≥1/100 to <1/10)

      Table listing common adverse events for upper and lower limb spasticity by system organ class
      System organ classPreferred termFrequency
      For focal upper limb spasticity in adult patients
      Gastrointestinal disordersNauseaCommon
      Musculoskeletal and connective tissue disordersPain in extremity, muscular weaknessCommon
      General disorders and administration site conditionsFatigue, peripheral oedemaCommon
      For focal lower limb spasticity in adult patients
      Skin and subcutaneous tissue disordersRashCommon
      Musculoskeletal and connective tissue disordersArthralgia, musculoskeletal stiffness, muscular weaknessCommon
      General disorders and administration site conditionsPeripheral oedemaCommon
      Injury, poisoning and procedural complicationsFallCommon
      System organ classPreferred termFrequency
      For focal upper limb spasticity in adult patients
      Gastrointestinal disordersNauseaCommon
      Musculoskeletal and connective tissue disordersPain in extremity, muscular weaknessCommon
      General disorders and administration site conditionsFatigue, peripheral oedemaCommon
      For focal lower limb spasticity in adult patients
      Skin and subcutaneous tissue disordersRashCommon
      Musculoskeletal and connective tissue disordersArthralgia, musculoskeletal stiffness, muscular weaknessCommon
      General disorders and administration site conditionsPeripheral oedemaCommon
      Injury, poisoning and procedural complicationsFallCommon

      Cases of iatrogenic botulism have been reported following injection of botulinum toxin products. Patients and caregivers should be advised to seek immediate medical advice if they experience any signs or symptoms consistent with the spread of botulinum toxin effect or if swallowing, speech or respiratory disorders arise (see section 4.9). Most cases have been reported following the use of botulinum toxin containing products when used for unapproved indications and/or administration into unapproved injection sites or following use of higher than recommended doses and the use of unlicensed products.5

      Adapted from the BOTOX® Summary of Product Characteristics.5

      Please refer to the Summary of Product Characteristics for further information.

      PSS: post-stroke spasticity.

      GUIDELINES FOR BOTOX®

       

      References

      1. Allergan. Data on file. INT/0423/2016
      2. Aurora SK, et al. Onabotulinum toxin A for treatment of chronic migraine: pooled analyses of the 56-week PREEMPT clinical program. Headache 2011;51(9):1358–73
      3. Blumenfeld AM, et al. Long-term study of the efficacy and safety of Onabotulinum toxin A for the prevention of chronic migraine: COMPEL study. J Headache Pain 2018;19(1):13
      4. AbbVie Data on file. Approval Dates for BOTOX® in UK. REF-112127.
      5. BOTOX® Summary of Product Characteristics. Available at: www.medicines.org.uk.
      6. Naumann M, et al. Safety and efficacy of botulinum toxin type A following long-term use. Eur J Neurol 2006;13 Suppl 4:35–40
      7. Whitcup SM. The history of botulinum toxins in medicine: A thousand year journey. Handb Experimental Pharmacol 2019;263:3–10

       

      References

      1. Allergan. Data on file. INT/0423/2016
      2. Aurora SK, et al. Onabotulinum toxin A for treatment of chronic migraine: pooled analyses of the 56-week PREEMPT clinical program. Headache 2011;51(9):1358–73
      3. Blumenfeld AM, et al. Long-term study of the efficacy and safety of Onabotulinum toxin A for the prevention of chronic migraine: COMPEL study. J Headache Pain 2018;19(1):13
      4. AbbVie Data on file. Approval Dates for BOTOX® in UK. REF-112127.
      5. BOTOX® Summary of Product Characteristics. Available at: www.medicines.org.uk.
      6. Naumann M, et al. Safety and efficacy of botulinum toxin type A following long-term use. Eur J Neurol 2006;13 Suppl 4:35–40
      7. Whitcup SM. The history of botulinum toxins in medicine: A thousand year journey. Handb Experimental Pharmacol 2019;263:3–10

      Please refer to the BOTOX® Summary of Product Characteristics for further information on adverse events, contraindications and special warnings and precautions for use. The BOTOX® Summary of Product Characteristics can be found here

      BOTOX® PRESCRIBING INFORMATION

      By clicking the link above you will leave the AbbVie Pro website and be taken to the eMC PI portal website.

      Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk/ or via the MHRA Yellow Card app, available in the Google Play or Apple App Stores.

      Adverse events should also be reported to AbbVie on GBPV@abbvie.com

       

      Date of preparation: May 2026. UK-BTX-260038.

       

       

      Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk or via the MHRA Yellow Card app, available in the Google Play or Apple App Stores. Adverse events should also be reported to AbbVie on GBPV@abbvie.com

       

      This website is for UK Healthcare Professionals only

      UK-ABBV-250400. Date of preparation December 2025. This website has been developed and funded by AbbVie Ltd.

      © 2023 AbbVie Ltd. All rights reserved. Registered Number: 08004972 England.