FDA-Approved Prescription Medications to Prevent Migraine

For more than a third of people who get migraines, trying to prevent them is as important as treating them when they occur. But even though quite a few medications and natural remedies are prescribed by healthcare providers for migraine prophylaxis (prevention), only eight are approved by the Food and Drug Administration (FDA) for this use.

Preventive migraine drugs are used to reduce the frequency, duration, and intensity of migraine attacks, but they aren't right for everyone. Studies suggest that less than 50 percent of people who could benefit from them actually take them. If you think you may be in this group, talk to your healthcare provider about exploring these FDA-approved medications. You may discover that when taken as directed, the right one for you may significantly prevent your migraines and generally improve your quality of life.

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Drugs Approved for Episodic Migraine Prevention

Episodic migraines are those that occur fewer than 15 days per month. The medications that have earned approval by the FDA fall into three categories:

Beta-Blockers

These are drugs that originally were developed to treat hypertension (high blood pressure), since they block adrenaline receptors, causing the vessels to relax. Researchers still do not fully understand how beta-blockers work for migraine prevention.

Although there are many beta-blockers on the market, and several are regarded as safe and effective for preventing migraines, only two are approved by the FDA for this specific purpose:

• Inderal (propranolol), which is also sold under the brand name Innopran
• Timolol, which is available as a generic only

Both are rated as Level A migraine prophylactic medications according to guidelines set jointly by the American Headache Society (AHS) and the American Academy of Neurology (AAN). This means they have been established as effective and should be offered to patients who would benefit from preventive therapy.

Anticonvulsants

Also sometimes referred to as membrane stabilizers, these medications are primarily prescribed to prevent seizures. They work by blocking channels in the body that deliver electrical impulses to nerve, muscle, and brain cells, as well as by enhancing the activity of gamma-aminobutyric acid (GABA), a neurotransmitter involved in regulating motor control, vision, and anxiety.

Researchers aren't certain how this process works to prevent migraine headaches, but it does so safely and effectively for most patients. The specific anti-seizure drugs that have FDA approval for migraine prophylaxis are:

• Depakote, Depakote ER (divalproex)
• Topamax, Qudexy XR, and Trokendi XR (topiramate)

As with the FDA-approved beta-blockers, these two anticonvulsants are listed as Level A medications for preventing migraines.

In order to reduce the risk of side effects, most healthcare providers will initially prescribe a low dose of an anticonvulsant drug—typically 25 mg per day—and gradually increase it until an effective dose is reached.

Calcitonin Gene-Related Peptide (CGRP) Inhibitors

These relatively new medications differ from beta-blockers and anticonvulsants in a significant way: They were developed solely for preventing chronic and episodic migraine headaches (with or without aura).

CGRP inhibitors are in a class of biologic drugs called monoclonal antibodies, which means that rather than being synthesized from chemicals, they are produced by altering the DNA inside of living cells. They work by targeting a protein in the brain and nervous system that plays a role in the progression and pain of migraines.

Five CGRP inhibitors have gained FDA approval for migraine prophylaxis:

• Aimovig (erenumab-aooe)
• Ajovy (fremanezumab-vfrm)
• Emgality (galcanezumab-gnlm)
• Vyepti (eptinezumab-jjmr)
• Nurtec ODT (rimegepant)

Most of these medications, except for Vyepti and Nurtec ODT, are administered as a shot with a thin needle just beneath the skin (subcutaneous injection) of the thigh or abdomen. With instruction, most people are able to learn to give themselves the shots.

Vyepti is given intravenously (IV), while Nurtec ODT is taken in pill form. Nurtec ODT is also approved to treat a migraine after it starts, making it the only medication available to both treat and prevent migraines.

Notably, all these mentioned CGRP medications were developed after the AHS/AAN guidelines were published, and so they do not have an effectiveness rating.

Drugs Approved for Preventing Chronic Migraines

In addition to being approved for preventing episodic migraine headaches, each of the CGRP inhibitors is also approved for preventing chronic (or transformed) migraine—when at least 15 migraine attacks occur per month for at least three months.

The only other drug approved by the FDA for chronic migraine prophylaxis is Botulinum toxin A—what most people know as Botox.

Botox (also called Onabotulinum-A) is a diluted form of a bacterial toxin that paralyzes muscles. Originally injected into the face to relax muscles and temporarily smooth out wrinkles, Botox was found to reduce the frequency of migraine headaches in people prone to them who used the drug for cosmetic purposes.

This prompted researchers to study Botox injections as a preventive treatment for migraines. It was found to be effective only for chronic migraines, a use that the FDA ultimately approved.

The Benefits of Choosing an FDA-Approved Drug

Choosing an FDA-approved drug for migraine prevention (or any other reason) ensures that, according to the FDA's website, "the agency has determined that the benefits of the product outweigh the known risks for the intended use." Approval is granted after review of lab, animal, and human testing done by drug manufacturers (the FDA does not test drugs itself).

As such, opting for an FDA-approved migraine drug is usually preferred. That said, there are times when your healthcare provider may recommend that a drug be used off-label, meaning that it is not approved by the FDA for the use your practitioner intends to prescribe it (though it is approved for other reasons). This is often done when FDA-approved choices have proven to be ineffective and when there is at least some evidence that the medication is helpful.

Using a drug off-label may be effective and perfectly safe for you. But given that the FDA cannot verify that its pros outweigh its cons for the purpose for which you're using it, there is more reason to use caution.

A Word From Verywell

Prophylaxis is a vital part of migraine management. The FDA-approved medications aren't the only drugs that may be prescribed to prevent headaches or to at least reduce the number of headaches that occur per month, but they are the ones that have been studied the most and found to be effective. If you aren't able to tolerate any of them or if none work for you, there are plenty of other options to discuss with your healthcare provider.