Can Prolia cause hair loss? This is a question raised by some patients prescribed Prolia (denosumab 60 mg) for osteoporosis or bone loss related to cancer treatment. Prolia is a RANKL inhibitor given as a subcutaneous injection every six months to reduce fracture risk. Reassuringly, hair loss (alopecia) is not listed as a recognised adverse effect in the UK Summary of Product Characteristics, and neither the MHRA nor the EMA has identified a pharmacovigilance signal linking denosumab to alopecia. This article explains what the evidence shows, outlines Prolia's known side effects, and advises when to seek medical guidance.
Summary: Prolia (denosumab) is not recognised as a cause of hair loss; alopecia does not appear in the UK Summary of Product Characteristics and no MHRA or EMA safety alert links denosumab to alopecia.
- Prolia (denosumab 60 mg) is a RANKL inhibitor given every six months by subcutaneous injection to treat osteoporosis and cancer-related bone loss.
- Hair loss is not listed as an adverse effect in the UK SmPC, EMA EPAR, or BNF denosumab monograph, and no regulatory pharmacovigilance signal has been identified.
- Postmenopausal women and men on androgen deprivation therapy — the main Prolia populations — are independently at risk of hair thinning due to hormonal changes unrelated to the drug.
- Well-documented serious risks include osteonecrosis of the jaw, atypical femoral fractures, hypocalcaemia, and multiple vertebral fractures on abrupt discontinuation (MHRA Drug Safety Update, 2020).
- Patients should not stop Prolia without medical supervision; an exit plan transitioning to an alternative antiresorptive therapy should be agreed with the prescriber.
- Any suspected adverse reaction, including hair changes, can be reported to the MHRA via the Yellow Card scheme at yellowcard.mhra.gov.uk.
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Does Prolia Cause Hair Loss?
Hair loss is not a recognised adverse effect of Prolia; it does not appear in the UK SmPC or EMA EPAR, and the MHRA has not issued any safety alert linking denosumab to alopecia.
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Prolia (denosumab 60 mg) is a biological medicine prescribed primarily for the treatment of osteoporosis in postmenopausal women and men at increased risk of fractures, as well as for bone loss associated with hormone-deprivation therapy in certain cancers. It works as a RANK ligand (RANKL) inhibitor, blocking a protein involved in the formation and activity of osteoclasts — the cells responsible for breaking down bone tissue. By inhibiting this pathway, Prolia helps to maintain or increase bone density. It is given as a subcutaneous injection of 60 mg every six months by a healthcare professional.
One question that patients and carers sometimes raise is whether Prolia can cause hair loss (alopecia). It is important to address this clearly: hair loss is not listed as a recognised adverse effect of Prolia in the UK Summary of Product Characteristics (SmPC), as published on the electronic Medicines Compendium (eMC), or in the European Medicines Agency (EMA) European Public Assessment Report (EPAR). The Medicines and Healthcare products Regulatory Agency (MHRA) has not issued any safety alert linking denosumab to alopecia. There is no established causal link between Prolia and hair loss.
Isolated spontaneous reports of hair changes during treatment do exist, as they do for many medicines, but no regulatory body has identified a pharmacovigilance signal connecting Prolia to alopecia. The underlying condition being treated, concurrent medications, nutritional status, hormonal changes (particularly in postmenopausal women), and age-related factors can all independently contribute to hair thinning or loss. Therefore, any new or worsening hair changes during treatment should be discussed with a GP or specialist to identify and address other potential causes.
| Side Effect | Frequency | Severity | Management |
|---|---|---|---|
| Hair loss (alopecia) | Not listed in UK SmPC or EMA EPAR; no MHRA signal identified | No established causal link | Discuss with GP; investigate thyroid, iron, hormonal, or other drug causes |
| Musculoskeletal pain (back, limbs, joints) | Common (>1 in 100) | Mild to moderate | Paracetamol for mild pain; discuss persistent or severe pain with GP |
| Hypocalcaemia (low blood calcium) | Uncommon generally; higher risk with renal impairment or vitamin D deficiency | Potentially serious; cardiac arrhythmia in severe cases | Correct before starting; ensure adequate calcium and vitamin D throughout; monitor serum calcium |
| Osteonecrosis of the jaw (ONJ) | Uncommon; higher risk with poor dental health or cancer-dose denosumab | Serious | Dental assessment before treatment; inform dentist; report jaw pain or swelling promptly |
| Atypical femoral fractures | Rare; risk increases with long-term use | Serious | Report new or persistent thigh or groin pain promptly for imaging assessment |
| Serious skin infections (cellulitis) | Uncommon (per UK SmPC) | Serious | Seek urgent medical attention for fever, redness, swelling, or skin pain |
| Multiple vertebral fractures on stopping treatment | Risk applies to all patients on discontinuation (MHRA Drug Safety Update 2020) | Serious | Do not stop without prescriber guidance; agree exit plan; consider transition to alternative antiresorptive therapy per NICE NG226 |
What the Clinical Evidence Says
Large-scale trials including the pivotal FREEDOM study did not identify alopecia as a significant adverse event, and post-marketing surveillance by the EMA and MHRA has not flagged hair loss as a denosumab safety signal.
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Large-scale clinical trials evaluating denosumab, including the pivotal FREEDOM trial (published in the New England Journal of Medicine, 2009) and its long-term extension studies (Journal of Bone and Mineral Research), did not identify alopecia as a statistically significant adverse event associated with Prolia use. These trials enrolled thousands of postmenopausal women over several years and systematically recorded adverse effects, providing a robust evidence base for the drug's safety profile. Hair loss did not emerge as a notable finding in these datasets.
A review of post-marketing surveillance data and pharmacovigilance reports held by the EMA and MHRA similarly does not highlight alopecia as a signal of concern for denosumab. Post-marketing surveillance is an important tool for detecting rare or delayed adverse effects that may not appear in pre-approval trials, and to date, no regulatory body has issued a safety communication linking Prolia to hair loss.
It is also worth considering the demographic most commonly prescribed Prolia. Postmenopausal women are at increased risk of androgenetic alopecia and diffuse hair thinning due to declining oestrogen levels — a process entirely independent of any medication. Similarly, men receiving androgen deprivation therapy for prostate cancer (another indication for Prolia) may experience changes in body and scalp hair related to hormonal shifts rather than the drug itself. Distinguishing medication-related effects from background physiological changes requires careful clinical assessment. If a patient notices hair loss after starting Prolia, a temporal relationship alone does not confirm causation, and a thorough evaluation of all contributing factors is essential before attributing the symptom to the medication.
Other Common and Serious Side Effects of Prolia
Recognised side effects include musculoskeletal pain, hypocalcaemia, osteonecrosis of the jaw, atypical femoral fractures, serious skin infections, and a risk of multiple vertebral fractures on stopping treatment.
While hair loss does not feature in Prolia's recognised side effect profile, there are several well-documented adverse effects that patients and clinicians should be aware of. Understanding these helps ensure that treatment is monitored appropriately and that any concerning symptoms are acted upon promptly. The following information is based on the UK SmPC (eMC) and the BNF denosumab monograph.
Common side effects (affecting more than 1 in 100 people) include:
-
Musculoskeletal pain — including pain in the back, limbs, and joints
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Urinary tract infections and upper respiratory tract infections
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Sciatica
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Skin reactions such as rash, eczema, or dermatitis at or away from the injection site
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Hypercholesterolaemia (raised cholesterol)
Uncommon but important side effects include:
- Hypocalcaemia (low blood calcium) — listed as uncommon in the UK SmPC for the general population, but the risk is substantially higher in patients with severe renal impairment or vitamin D deficiency. Symptoms may include muscle cramps, tingling, or, in severe cases, cardiac arrhythmias.
Serious but less common side effects that require prompt medical attention include:
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Osteonecrosis of the jaw (ONJ) — a serious condition involving bone death in the jaw, particularly relevant in patients with poor dental health or those receiving high-dose denosumab for cancer indications
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Osteonecrosis of the external auditory canal (EAOEC) — a rare but recognised adverse effect; patients should report persistent ear pain, discharge, or hearing changes
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Atypical femoral fractures — unusual stress fractures of the thigh bone, particularly with long-term use
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Severe hypocalcaemia — especially in patients with renal impairment or vitamin D deficiency
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Serious skin infections (cellulitis) — denosumab has immunomodulatory properties and is associated with an increased risk of serious skin and soft tissue infections per the UK SmPC
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Risk of multiple vertebral fractures after stopping or delaying treatment — the MHRA issued a Drug Safety Update (2020) highlighting that stopping or delaying denosumab can lead to a rapid loss of bone density and a risk of multiple vertebral fractures. Patients should not discontinue treatment without first discussing an exit plan with their prescriber.
Patients are advised to ensure adequate calcium and vitamin D intake during treatment, as detailed in the SmPC and supported by guidance from the National Osteoporosis Guideline Group (NOGG) and the Royal Osteoporosis Society (ROS). Dental health should be assessed before commencing treatment, and elective dental procedures are best completed prior to starting Prolia where possible.
When to Speak to Your GP or Specialist
Seek prompt medical advice for muscle cramps, jaw or ear pain, thigh pain, signs of infection, or a missed injection; do not stop Prolia without first discussing an exit plan with your prescriber.
Knowing when to seek medical advice during Prolia treatment is an important aspect of patient safety. Although many side effects are mild and manageable, some symptoms warrant prompt attention. Patients should be encouraged to contact their GP, specialist nurse, or hospital team if they experience any of the following:
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Muscle cramps, spasms, or numbness — these may indicate hypocalcaemia and should be assessed urgently
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Jaw pain, swelling, or numbness, particularly after dental work — this could suggest osteonecrosis of the jaw
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Persistent ear pain, discharge, or hearing changes — these may be signs of osteonecrosis of the external auditory canal (EAOEC) and should be assessed promptly
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Thigh or groin pain that is new, persistent, or worsening — this may be an early sign of an atypical femoral fracture
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Signs of infection such as fever, redness, swelling, or pain, particularly around the skin or injection site
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Signs of a severe allergic reaction — including wheezing, facial swelling, or a widespread rash
Patients should also contact their prescriber promptly if a scheduled injection is missed or delayed. As highlighted in the MHRA Drug Safety Update (2020), delaying or stopping denosumab without medical supervision carries a risk of rapid bone loss and multiple vertebral fractures. An exit plan — which may involve transitioning to an alternative antiresorptive therapy — should be discussed with the prescriber before stopping treatment, in line with NICE guideline NG226 and NOGG recommendations.
Regarding hair loss specifically: if a patient notices significant or sudden hair shedding after starting Prolia, they should raise this with their GP. The consultation should explore other potential causes, including thyroid dysfunction, iron deficiency anaemia, nutritional deficiencies, other medications (such as anticoagulants or antidepressants), and hormonal changes. Blood tests can help identify or exclude these conditions. Patients should not stop taking Prolia without first consulting their prescriber, given the well-documented risk of rebound bone loss and increased fracture risk on discontinuation.
Managing Side Effects While on Prolia
Ensure adequate calcium and vitamin D intake, maintain good dental hygiene, attend regular blood tests, and report any new symptoms to your clinical team; hair loss concerns should prompt a holistic review of other potential causes.
For most patients, Prolia is well tolerated, and side effects — where they occur — are often manageable with appropriate support and monitoring. There are several practical steps that can help patients get the most from their treatment whilst minimising discomfort.
To support bone health and reduce the risk of hypocalcaemia:
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Ensure adequate daily intake of calcium and vitamin D, either through diet or supplementation. The UK SmPC requires that hypocalcaemia is corrected before starting Prolia and that all patients receive adequate calcium and vitamin D throughout treatment. NOGG and the Royal Osteoporosis Society typically recommend around 1,000 mg of calcium and 800 IU of vitamin D daily for patients on antiresorptive therapy, though individual needs vary.
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Serum calcium should be checked before each dose and within two weeks of the first dose in patients with severe renal impairment or those at high risk of hypocalcaemia, as specified in the SmPC.
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Attend regular blood tests as requested by your clinical team, particularly if you have kidney problems.
To protect dental health:
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Maintain good oral hygiene and attend regular dental check-ups
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Inform your dentist that you are taking Prolia before any invasive dental procedures
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Report any jaw pain, swelling, or ear symptoms promptly
For musculoskeletal pain, which is among the most commonly reported side effects, over-the-counter analgesics such as paracetamol may provide relief. Persistent or severe pain should be discussed with a GP.
If hair loss is a concern, a holistic review of the patient's overall health, diet, and medication list is advisable. Ensuring adequate intake of iron, zinc, and protein through a balanced diet may help address hair thinning that is unrelated to Prolia. Note that routine supplementation with biotin (vitamin B7) is not recommended unless a deficiency has been confirmed; the MHRA has also warned that high-dose biotin supplements can interfere with certain laboratory tests, potentially leading to inaccurate results. Referral to a dermatologist may be appropriate if hair loss is significant or unexplained. Patients should feel empowered to discuss any symptom with their healthcare team, as open communication supports both safety and treatment adherence.
MHRA Guidance and Reporting Adverse Reactions
The MHRA has not linked Prolia to hair loss but has issued safety updates on vertebral fracture risk on discontinuation, osteonecrosis, and hypocalcaemia; suspected reactions should be reported via the Yellow Card scheme.
The MHRA is the UK's regulatory authority responsible for ensuring that medicines, including Prolia, meet appropriate standards of safety, quality, and efficacy. The MHRA continuously monitors the safety of licensed medicines through its pharmacovigilance programme, which includes reviewing data from clinical trials, post-marketing studies, and spontaneous adverse event reports submitted by both healthcare professionals and patients.
Currently, the MHRA has not issued any safety alert or Drug Safety Update linking Prolia (denosumab) to hair loss. The MHRA has, however, issued important safety communications on other known risks associated with denosumab that prescribers and patients should be aware of:
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MHRA Drug Safety Update (2020): Denosumab 60 mg (Prolia) — risk of multiple vertebral fractures after stopping or delaying treatment. Patients must not discontinue Prolia without medical supervision and should have an exit plan in place.
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MHRA guidance on osteonecrosis of the jaw (ONJ) and osteonecrosis of the external auditory canal (EAOEC): Both are recognised risks; dental assessment before treatment and prompt reporting of ear or jaw symptoms are advised.
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Monitoring for hypocalcaemia: Particularly important in patients with severe renal impairment or vitamin D deficiency, as detailed in the UK SmPC.
These communications are publicly available on the MHRA website and are reflected in the current UK SmPC (eMC) and BNF denosumab monograph. Healthcare professionals prescribing Prolia should remain familiar with these updates and ensure that patients receive accurate, up-to-date information about their treatment.
Patients and healthcare professionals in the UK are encouraged to report any suspected adverse drug reactions — including hair loss, if believed to be related to Prolia — through the Yellow Card scheme, the MHRA's national pharmacovigilance reporting system. Reports can be submitted online at yellowcard.mhra.gov.uk, via the Yellow Card app, or through a GP or pharmacist. Reporting suspected reactions, even when causality is uncertain, contributes to the ongoing safety monitoring of medicines and helps identify rare or previously unrecognised effects at a population level. Shared decision-making, informed consent, and regular clinical review remain central to the safe and effective use of this medicine.
Frequently Asked Questions
Can Prolia cause hair loss in postmenopausal women?
Prolia is not recognised as a cause of hair loss in postmenopausal women or any other patient group; alopecia does not appear in the UK Summary of Product Characteristics and no regulatory body has identified a link. Postmenopausal women are independently prone to hair thinning due to declining oestrogen levels, which can be mistakenly attributed to a new medication.
Is hair thinning a known side effect of denosumab?
No, hair thinning is not listed as a known side effect of denosumab (Prolia) in the UK SmPC, BNF, or EMA assessment reports. If you notice hair thinning while taking denosumab, your GP should investigate other causes such as thyroid dysfunction, iron deficiency, or hormonal changes.
What should I do if I notice hair loss after starting Prolia?
Speak to your GP, who can arrange blood tests to check for thyroid problems, iron deficiency anaemia, nutritional deficiencies, and hormonal imbalances — all common causes of hair loss unrelated to Prolia. Do not stop taking Prolia without medical advice, as abrupt discontinuation carries a well-documented risk of rapid bone loss and multiple vertebral fractures.
What is the difference between Prolia and other osteoporosis treatments like bisphosphonates?
Prolia (denosumab) is a biological RANKL inhibitor given by injection every six months, whereas bisphosphonates such as alendronic acid are oral tablets taken weekly or monthly and work by a different mechanism to reduce osteoclast activity. Unlike bisphosphonates, stopping Prolia without transitioning to another antiresorptive therapy carries a specific risk of rebound bone loss and multiple vertebral fractures, as highlighted in the MHRA's 2020 Drug Safety Update.
Can I take biotin supplements to help with hair loss while on Prolia?
Routine biotin supplementation is not recommended unless a confirmed deficiency has been identified, and the MHRA has warned that high-dose biotin can interfere with certain laboratory tests, potentially producing inaccurate results. If hair loss is a concern, discuss it with your GP or a dermatologist rather than self-treating with supplements.
How do I report a suspected side effect from Prolia in the UK?
Suspected adverse reactions to Prolia, including any hair changes you believe may be related, can be reported to the MHRA through the Yellow Card scheme at yellowcard.mhra.gov.uk, via the Yellow Card app, or through your GP or pharmacist. Reporting is encouraged even when you are unsure whether the drug is responsible, as it contributes to ongoing national safety monitoring.
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