Safety and tolerability

Naltrexone

  • Approved in 1984 1
  • Prescribed to >1 million patients over 25 years 2
  • Used for alcohol and opioid addiction 1 *

Bupropion

  • Approved in 1989 3
  • Prescribed to over 50 million patients over 25 years 2
  • Used for smoking cessation and to treat depression 3 *
*Mysimba is not indicated for smoking cessation, to treat depression, or to treat alcohol or opioid addiction.
Mysimba — naltrexone HCl/bupropion HCl 8mg/90mg Prolonged-Release Tablets

Mysimba has over 850,000 patient-years of worldwide treatment experience since 2014 4

Very common and common adverse events reported with naltrexone/bupropion as a combination treatment are listed below5 :

Very Common adverse effects: (≥1/10) Headache, Nausea, Constipation, Vomiting
Common adverse effects: (≥1/100 to <1/10) Dizziness, Tremor, Dysgeusia, Lethargy, Somnolence, Anxiety, Insomnia, Tinnitus, Vertigo, Palpitations, Heart rate increased, Hot flush, Hypertension, Blood pressure increased, Dry mouth, Abdominal pain upper, Abdominal pain, Hyperhidrosis, Pruritus Alopecia, Rash, Fatigue, Feeling jittery, Irritability

Please consult the full Summary of Product Characteristics before prescribing. A Physician Prescribing Checklist is recommended to be completed prior to prescribing and is designed to support appropriate prescribing and ensure safe use of the product among UK healthcare professionals.

Contraindications and prescribing considerations

Contraindications 5

DO NOT PRESCRIBE if the patient has any of these factors*
  • Uncontrolled hypertension
  • Severe hepatic impairment or end stage renal failure
  • Current seizure disorder, history of seizures or known CNS tumour
  • Ongoing acute alcohol or benzodiazepine or opioid withdrawal
  • Current or previous diagnosis of bulimia or anorexia nervosa
  • History of bipolar disorder
  • Currently treated with:
  • • Bupropion or naltrexone
  • • Opioid agonists
  • • Monoamine oxidase inhibitors (MAO) within the last 14 days
Increased risk of adverse reaction 5

Treatment should only be initiated or maintained after full evaluation of the possible benefits and risks and review of Section 4.4 of the SmPC.

  • Controlled hypertension (potential increased blood pressure risk)
  • Angina or recent history of myocardial infarction
  • Mild hepatic impairment (dose adjustment necessary) , moderate hepatic impairment (treatment not recommended)
  • Moderate or severe renal impairment (dose adjustment necessary) . If diabetic or elderly patient or at risk for renal insufficiency, assess eGFR prior to initiating treatment
  • Depression or history of suicidal thoughts/suicidal attempt
  • History of mania
  • Risk factors for seizures – such as: history of head trauma, episodes of hypoglycaemia from diabetes treatment, concomitant medication that could lower the seizure threshold such as: antipsychotics, antidepressants, antimalarials, tramadol, theophyline, systemic steroids, quinolones, or sedating antihistamines
*Hypersensitivity to the active substance(s) or to any of the excipients.

References:

  1. MedlinePlus. Naltrexone. Updated October 15, 2017. Accessed January 17, 2025. https://medlineplus.gov/druginfo/meds/a685041.html
  2. Data on file, Currax Pharmaceuticals LLC
  3. Fava M, Rush AJ, Thase ME, et al. 15 years of clinical experience with bupropion HCl: from bupropion to bupropion SR to bupropion XL. Prim Care Companion J Clin Psychiatry. 2005;7:106-113.
  4. Data on File, Currax Pharmaceuticals LLC, patient use to December 2025
  5. Mysimba® SmPC available at https://www.medicines.org.uk/emc/product/2684/smpc#gref accessed September 2026
Reporting adverse effects: Adverse effects should be reported. Reporting forms and information can be found at yellowcard.mhra.gov.uk or search for MHRA Yellow Card in the Google Play or Apple App Store. Alternatively you can report a suspected adverse drug reaction to the Yellow Card scheme by calling 0800 731 6789 Adverse events should also be reported to Orexigen®: +44 20 3966 0116 or currax.mi@primevigilance.com.
Important Safety Information

Please refer to the Mysimba® Summary of Product Characteristics (SmPC)


▼ Black Triangle

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

MYS 014
Important Safety Information

Please refer to the Mysimba® Summary of Product Characteristics (SmPC)


▼ Black Triangle

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

MYS 014
Important Safety Information

Please refer to the Mysimba® Summary of Product Characteristics (SmPC)


▼ Black Triangle

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

MYS 014