Domperidone: new contraindication in patients with phaeochromocytoma due to the risk of severe hypertension
The product information has been updated for all domperidone products, to include a contraindication for patients with confirmed or suspected phaeochromocytoma (a rare tumour of the adrenal gland), due to the risk of episodes of severe hypertension.
Advice for Healthcare Professionals:
- a small number of reports have been received relating to severe episodes of hypertension in patients with phaeochromocytoma (a rare tumour of the adrenal gland) following administration of domperidone
- domperidone is now contraindicated in patients with confirmed or suspected phaeochromocytoma
- patients with confirmed or suspected phaeochromocytoma should stop taking domperidone immediately and be switched to an alternative treatment
- be aware that administration of domperidone can unmask phaeochromocytomas. If a patient taking domperidone has an episode of severe hypertension, consider further investigations for phaeochromocytoma
- domperidone should be used at the lowest effective dose for the shortest possible duration and maximum treatment duration should not usually exceed 1 week
- for patients receiving palliative care, an individual benefit risk decision on treatment should be made in discussion with the patient
- report suspected adverse drug reactions associated with domperidone via the Yellow Card scheme
Advice for Healthcare Professionals to Provide to Patients:
- stop taking domperidone immediately if you have been diagnosed with phaeochromocytoma (a rare tumour of the adrenal gland) by your doctor. Speak to your doctor or pharmacist about alternative treatment options
- seek medical attention immediately if you experience symptoms of severe high blood pressure. Symptoms can include, but are not limited to: persistent headache, blurred vision, shortness of breath and chest pain
- report suspected adverse drug reactions associated with domperidone via the Yellow Card scheme
Background
Domperidone is a dopamine antagonist with anti-emetic properties. It is licensed for use in adults and in children 12 years and above. Phaeochromocytomas are rare tumours of the adrenal gland and are often diagnosed through incidental imaging.
A recent European review of safety data for domperidone identified an association between domperidone and episodes of severe hypertension in patients with phaeochromocytoma following a small number of reports of this event. As a result, recommendations have been made to update the product information to include a contraindication for use of domperidone in patients with phaeochromocytoma due to the risk of severe hypertension.
Domperidone and introduction of contraindication for use in phaeochromocytoma
The findings of the European review were considered by the UK’s Pharmacovigilance Expert Advisory Committee (PEAG) of the Commission on Human Medicines (CHM) who agreed with the recommendations and advised that the MHRA inform healthcare professionals and patients of this new contraindication.
The MHRA has not received any UK Yellow Card reports of domperidone and severe hypertension in patients with phaeochromocytoma. Four reports were considered in the European review. Phaeochromocytomas themselves are rare with a global prevalence of 19.8 per 1,000,000 people[footnote 1]. Total prescribing of domperidone averages 222,000 items per year across NHS England[footnote 2]. There are existing restrictions on domperidone prescribing, see further detail below.
New advice when prescribing domperidone
Do not prescribe domperidone to patients with confirmed or suspected phaeochromocytoma as domperidone is now contraindicated in this patient population. If patients with confirmed or suspected phaeochromocytoma are taking domperidone, treatment should be discontinued immediately and the patient switched to an alternative treatment. Patients should be advised to seek medical attention immediately if they experience symptoms of severe high blood pressure. Symptoms can include, but are not limited to: persistent headache, blurred vision, shortness of breath and chest pain.
For patients receiving palliative care, an individual benefit risk decision on treatment should be made in discussion with the patient.
Reminder of existing domperidone advice
Healthcare professionals are reminded of the existing recommendations and restrictions on domperidone prescribing (See December 2019 DSU).
- domperidone should be used at the lowest effective dose for the shortest possible duration and maximum treatment duration should not usually exceed 1 week
- for adults and adolescents 12 years of age or older and weighing 35 kg or more, the recommended maximum dose in 24 hours is 30 mg (dose interval: 10 mg up to 3 times a day)
- domperidone is authorised for the relief of symptoms of nausea and vomiting only in adults and adolescents 12 years of age or older or weigh 35kg or more
- consider alternative treatments to domperidone in children younger than 12 years of age who need relief of symptoms of nausea and vomiting
- domperidone is contraindicated in people receiving other medications known to prolong QT interval or potent CYP3A4 inhibitors
Reporting advice
Healthcare professionals, patients, and caregivers are asked to submit reports using the Yellow Card scheme electronically using:
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the Yellow Card website.
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the Yellow Card app; download from the Apple App Store or Google Play Store
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some clinical IT systems for healthcare professionals (EMIS, SystmOne, Vision, MiDatabank, and Ulysses)
When reporting suspected adverse drug reactions, please provide as much information as possible, including information about medical history, any concomitant medication, onset timing, and treatment dates.
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Additional information
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References
Stakeholder engagement:
- British and Irish Hypertension Society
- Devolved Administrations
- NHS England Patient Safety Team and Specialist Pharmacy Service
Article citation: MHRA Drug Safety Update volume 19, issue 12: July 2026: 2
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Giacomo Vitturi, Crisafulli S, Alessi Y, Frontalini S, Stano MG, Fontana A, et al. Global epidemiology of pheochromocytoma: a systematic review and meta-analysis of observational studies. Journal of Endocrinological Investigation. 2025 Jul 2. Available from: https://link.springer.com/article/10.1007/s40618-025-02639-9 ↩
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Search GP prescribing data [Internet]. Open Prescribing. Bennett Institute for Applied Data Science; [cited 2026 Mar 27]. Available from: https://openprescribing.net/analyse/#org=CCG&numIds=0406000J0&denom=nothing&selectedTab=summary ↩