Does Qulipta (atogepant) cause hair loss?

No, Qulipta (generic name: atogepant) did not lead to hair loss (alopecia) during clinical trials submitted for FDA-approval. Qulipta is an oral CGRP receptor antagonist (gepant) used to help prevent migraine headache pain. Hair loss is not listed as a side effect in its FDA-approved product label.

However, reports suggest that alopecia (hair loss) is an emerging side effect with certain CGRP inhibitor migraine medicines, although larger and more adequately controlled studies are needed.

Qulipta works by blocking a small protein known as calcitonin-related gene peptide (CGRP) found in the nerves that supply the head and neck. CGRP causes blood vessels to widen leading to inflammation and pain. Blocking CGRP can help to lessen migraine headache pain.

The safety of Qulipta was studied in over 2,600 patients during clinical studies. The most common side effects (in at least 4% of patients) included nausea, constipation and somnolence / fatigue (feeling tired or sleepy). Decreased appetite and dizziness also occurred.

If you are experiencing hair thinning or hair loss, it may be due to a variety of reasons, including a medical condition or another treatment. Contact your healthcare provider for further evaluation. You can also report side effects to the FDA at 1-800-FDA-1088.

Do CGRP inhibitors cause hair loss?

Alopecia has been reported as a possible, but not proven, side effect with some CGRP inhibitors in post-marketing FDA Medwatch reports and the FDA Adverse Event Reporting System (FAERS). Medwatch is a voluntary reporting system for consumers, patients and healthcare professionals to report safety-related information from products such as prescription and OTC medicines, medical devices and cosmetics.

There are two types of CGRP inhibitors – monoclonal antibodies and CGRP receptor antagonists (gepants). Monoclonal antibodies target either CGRP or the CGRP receptor and are used for migraine prevention. Gepants block the CGRP receptor and are used to both treat and prevent migraines.

Medwatch Reports

In a clinical review of FDA reports for hair loss through August 2022, the majority involved the monoclonal antibody CGRP inhibitors (vs. the gepants), but gepants are more recently approved. Most of the reports were in women and were not serious in nature.

FDA reports of hair loss with monoclonal antibody CGRP inhibitors:

• Aimovig (erenumab-aooe) - 1,158 reports; approved May 17, 2018
• Emgality (galcanezumab-gnlm) - 554 reports; approved Sept 27, 2018
• Ajovy (fremanezumab-vfrm) - 175 reports; approved Sept 14, 2018
• Vyepti (eptinezumab-jjmr) - 23 reports; approved Feb 21, 2020

FDA reports of hair loss with CGRP receptor antagonists (gepants):

• Nurtec ODT (rimegepant) - 26 reports; approved Feb 27, 2020
• Ubrelvy (ubrogepant) - 4 reports; approved Dec 23, 2019
• Qulipta (atogepant) - 3 reports; approved Sept 28, 2021

Note: Zavzpret (zavegepant), a gepant approved March 10, 2023, was not yet approved at the time of data review.

These reports do not prove that the CGRP inhibitors were responsible for the hair loss. The FDA Medwatch program gathers voluntary reports from a population of uncertain size, so it is not possible to prove the side effect was caused by the drug or know how many people it may affect.

Differing numbers of reports may be associated with the time that the drug had been available on the market or the number of prescriptions used. For example, Aimovig was the first CGRP inhibitor approved in May of 2018, and this may be a reason why it is associated with a higher numbers of reports.

These safety reports suggest alopecia (hair loss) may be a newly recognized side effect with CGRP inhibitor treatment, but additional clinical data are needed.

Related Questions

• How do Ubrelvy, Qulipta and Nurtec compare for migraines?
• What are the new drugs for the treatment of migraines?
• Does Qulipta cause weight loss?

Case Studies

In addition, a review describes 2 case reports of hair loss in 2 women with extensive use of monoclonal antibody CGRP inhibitors. These women reported hair starting within 2 weeks to 3 months of treatment initiation, and improving about about 6 weeks after stopping treatment.

Case 1

Hair loss was reported began in a 69-year old woman within 3 months of starting Aimovig (erenumab) 70 mg subcutaneous injection once per month. Hair loss continued during the period of Aimovig use.

After discontinuing Aimovig for one month, she started using Ajovy (fremanezumab) 225 mg injection every month, but discontinued treatment after 3 months. At a 6-month follow up exam, she reported continued but stabilized hair loss.

Case 2

In a second case, a 33-year old woman reported hair loss beginning 2 weeks after her first dose of Aimovig treatment (70 mg subcutaneous injection once per month). After 3 doses, she switched to Emgality (galcanezumab) due to insurance issues, starting with the 240 mg loading dose. However, she stopped Emgality at this dose due to continued hair loss, which resolved 6 weeks after discontinuing the drug.

Eight months later she used one dose of Ajovy (fremanezumab) 225 mg subcutaneous injection, but noticed hair loss in 3 weeks, and stopped treatment. Her hair loss improved in 6 weeks.

Over two years later, she started treatment with Nurtec ODT (rimegepant), 75 mg by mouth, taken every other day for 3 months. No hair loss with Nurtec ODT (a gepant) was reported but treatment for her migraines was not effective. After stopping Nurtec ODT, she started Qulipta (atogepant), at 60 mg daily for migraine prevention, which was effective and not associated with hair loss.

Both Nurtec ODT and Qulipta are CGRP inhibitor gepants, while AImovig, Emgality and Ajovy are monoclonal antibody CGRP inhibitors.

Why do CGRP inhibitors cause hair loss?

It is not fully known if, or why CGRP inhibitors may cause hair loss (alopecia). It is thought that medicines that interfere with calcitonin gene-related peptide (CGRP) or its receptor may disrupt blood flow in the small vessels of the head and neck, which may interfere with hair growth or resting phases.

Does Qulipta cause any serious side effects?

In general, Qulipta is well-tolerated by most people with less than 1% of people in studies stopping treatment due to a side effect.

In studies, the most serious side effect reported with Qulipta was:

• Severe allergies (hypersensitivity reactions) - including anaphylaxis (life-threatening allergic reaction), shortness of breath, rash, itching, hives, and swelling around the face area. These reactions may occur days after you take your treatment.
• If you experience any of these allergy symptoms while taking Qulipta, stop taking the medicine and get emergency medical help right away.

Other side effects include elevated liver enzymes, which may be temporary. No serious side effects due to elevated liver enzymes were reported. However, Qulipta should not be used in people with severe liver problems. If you have kidney disease, your doctor may need to adjust your dose.

At least a 7% weight loss was also reported in 3.8% to 5.3% of people taking Qulipta.

These are not all the possible side effects of Qulipta. For more information, ask your healthcare provider for details on side effects and view the product information.

See also: Qulipta side effects (in more detail)

Bottom Line

• Hair loss was not reported as a side effect with Qulipta in studies submitted for FDA approval.
• Drugs in the CGRP inhibitor class are increasingly being associated with hair loss, but it is not known if individual drugs cause this side effect or if it is a class effect for all CGRP inhibitors (both gepants and monoclonal antibodies).
• If you have experienced hair thinning or hair loss (alopecia), contact your healthcare provider for further evaluation.

This is not all the information you need to know about Qulipta (erenumab-aooe) for safe and effective use. Review the full product information, and discuss this information with your doctor or other health care provider.