Meloxicam and rizatriptan

Meloxicam/rizatriptan is used to treat acute migraines with or without aura in adults. It is NOT USED:

• For migraine prevention
• To decrease the number of migraines you have
• For other types of migraine, such as hemiplegic (these make you unable to move on one side of your body) or basilar (a rare form of migraine with aura)
• For cluster headaches
• In children.

Meloxicam/rizatriptan (brand name Symbravo) is a combination oral prescription migraine medication that contains both meloxicam (an NSAID) and rizatriptan (a triptan), providing migraine relief through two different mechanisms of action.

Meloxicam/rizatriptan is only taken when you have a migraine attack. The maximum dose is 1 tablet every 24 hours. Take it exactly as prescribed and for the shortest time needed.

Meloxicam/rizatriptan gained FDA approval on January 30, 2025. There is no generic.

Dual-Mechanism Migraine Treatment

The two active ingredients in meloxicam/rizatriptan work via two different pathways to provide migraine relief.

• Meloxicam NSAID Component: Meloxicam is a nonsteroidal anti-inflammatory drug (NSAID) that relieves pain, reduces fever, and has anti-inflammatory effects. Its mechanism is not completely understood but is thought to involve inhibition of cyclooxygenase (COX-1 and COX-2) and prostaglandin synthesis, addressing the inflammatory component of migraine pain.
• Rizatriptan Triptan Component: Rizatriptan is a triptan medication that works by binding to 5-HT 1B/1D receptors located on blood vessels inside the brain and sensory nerves of the trigeminal system. This mechanism helps address the vascular changes associated with migraine attacks, although the exact way it works is not fully understood.

Take meloxicam/rizatriptan exactly as your healthcare provider tells you to take it.

• It is not known if taking more than 1 dose of meloxicam/rizatriptan in 24 hours is safe and effective. Talk to your healthcare provider about what to do if your headache does not go away or comes back.
• Swallow meloxicam/rizatriptan tablets whole.
• Do not crush, divide, or chew meloxicam/rizatriptan tablets.
• Meloxicam/rizatriptan can be taken with or without food.
• If you take too much Meloxicam/rizatriptan, call your healthcare provider or go to the nearest hospital emergency room right away.

Absolute Contraindications

Do not take meloxicam and rizatriptan if you:

• Have or have had heart problems
• Have heart bypass surgery scheduled, or have recently had heart bypass surgery
• Have or have had a stroke or a transient ischemic attack (TIA)
• Have or have had blood vessel problems, including ischemic bowel disease.
• Have or had hemiplegic migraines or basilar migraines
• Have narrowing of blood vessels of your legs and arms (peripheral vascular disease), stomach (ischemic bowel disease), or kidneys
• Have uncontrolled high blood pressure
• Take a medicine that contains propranolol
• Have taken any medicines in the last 24 hours that are called 5-HT1 agonists (triptans) or contain ergotamine
• Take an antidepressant medicine called a monoamine oxidase (MAO) inhibitor, or have taken a MAO inhibitor within the last 2 weeks
• Are allergic to meloxicam, rizatriptan, NSAIDs, or any of the ingredients in the tablets. See the end of this Medication Guide for a complete list of ingredients
• Have had an asthma attack, hives, or other allergic reaction after taking aspirin or any other NSAIDs
• Have moderate to severe kidney problems and are at risk of kidney failure, or if you are on dialysis.

Do not use meloxicam and rizatriptan for migraine prevention or in children due to safety concerns or unestablished effectiveness.

Caution Needed

Before taking this medicine, tell your healthcare provider about all your medical conditions, including if you have:

• Have or have had heart problems, high blood pressure, chest pain, or shortness of breath
• Have risk factors for heart problems or blood vessel problems, such as high blood pressure, high cholesterol, smoking, diabetes, obesity, family history of heart problems, you are postmenopausal or a male over 40
• Have kidney or liver problems
• Have asthma
• Have any other medical condition
• Are pregnant or plan to become pregnant
• Are breastfeeding or plan to breastfeed.

Pregnancy

Taking NSAIDs, including meloxicam and rizatriptan, at about 20 weeks of pregnancy or later may harm your unborn baby.

• If you need to take NSAIDs for more than 2 days when you are between 20 and 30 weeks of pregnancy, your healthcare provider may need to monitor the amount of fluid in your womb around your baby.
• You should not take NSAIDs after about 30 weeks of pregnancy.

Breastfeeding

Talk to your healthcare provider about the best way to feed your baby if you are taking meloxicam and rizatriptan.

Common Side Effects

The most common side effects of meloxicam/rizatriptan are:

• Dizziness
• Feeling tired (fatigued).

These side effects may affect your ability to drive or operate machinery.

Serious Side Effects and Warnings

Meloxicam/rizatriptan (Symbravo) carries a Boxed Warning for the risk of serious cardiovascular and gastrointestinal side effects.

Increased risk of a heart attack or stroke that can lead to death (Boxed Warning)

This risk may happen early in treatment and may increase:

• with increasing doses of NSAIDs (relating to the meloxicam component)
• with longer use of NSAIDs.

Do not take meloxicam/rizatriptan right before or after a heart surgery called a coronary artery bypass graft (CABG).

Avoid taking meloxicam/rizatriptan after a recent heart attack unless your healthcare provider tells you to. You may have an increased risk of another heart attack if you take NSAIDs after a recent heart attack.

Stop taking meloxicam/rizatriptan and get emergency help right away if you have any of the following symptoms of a heart attack or stroke:

• discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and comes back
• severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
• pain or discomfort in your arms, back, neck, jaw, or stomach
• shortness of breath with or without chest discomfort
• breaking out in a cold sweat
• nausea or vomiting
• feeling lightheaded
• weakness in one part or on one side of your body
• slurred speech

Meloxicam/rizatriptan is not for people with risk factors for heart disease unless a heart exam is done and shows no problem. You have a higher risk for heart disease if you:

• have high blood pressure
• have high cholesterol levels
• smoke
• are overweight
• have diabetes
• have a family history of diabetes

Increased risk of bleeding, ulcers, and tears (perforation) of the esophagus (tube leading from the mouth to the stomach), stomach, and intestines (Boxed Warning)

These can happen anytime during use, without warning symptoms, and may cause death. These side effects are attributable to the meloxicam component.

The risk of getting an ulcer or bleeding increases with:

• history of stomach ulcers, or stomach or intestinal bleeding with use of NSAIDs
• taking medicines such as corticosteroids, anticoagulants, SSRIs or SNRIs (antidepressants), or aspirin (an antiplatelet)
• increasing doses of NSAIDs
• older age
• longer use of NSAIDs
• poor health
• smoking
• advanced liver disease
• drinking alcohol
• bleeding problems.

Serious allergic reactions or serious skin reactions that can be life-threatening

Stop taking meloxicam/rizatriptan and get emergency help right away if you develop:

• sudden wheezing
• swelling of your lips, tongue, throat, or body
• rash
• fainting
• problems breathing or swallowing
• reddening of your skin with blisters or peeling
• blisters or bleeding of your lips, eyelids, mouth, nose, or genitals.

Interactions with fever and pain medications

Meloxicam/rizatriptan contains an NSAID (meloxicam).

• Do not take meloxicam/rizatriptan with other medicines to lessen pain or fever or with other medicines for colds or sleeping problems without talking to your healthcare provider first, because they may also contain an NSAID.

Stomach and intestinal problems

Get emergency help right away if you have:

• sudden or severe stomach pain
• severe stomach pain after meals
• sudden unexplained weight loss
• severe nausea or vomiting
• severe constipation or diarrhea
• bloody diarrhea.

Problems with blood circulation to your legs and feet (peripheral vascular ischemia)

Get emergency help right away if you have any of the following symptoms of peripheral vascular ischemia, including:

• cramping and pain in your legs or hips
• feeling of heaviness or tightness in your leg muscles
• burning or aching pain in your feet or toes while resting
• numbness, tingling, or weakness in your legs
• cold feeling or color changes in 1 or both legs or feet.

Medication overuse headaches

Some people who use too many meloxicam/rizatriptan tablets may have worse headaches (medication overuse headache). If your headaches get worse, your healthcare provider may decide to stop your treatment with meloxicam/rizatriptan.

Serotonin syndrome

A condition called serotonin syndrome can happen when Triptan medicines, such as meloxicam/rizatriptan are taken with certain other medicines called SSRIs or SNRIs. Stop taking Meloxicam/rizatriptan and get emergency help right away if you have any of the following symptoms of serotonin syndrome:

• mental changes such as seeing things that are not there (hallucinations)
• agitation or coma
• high body temperature
• tight muscles
• fast heartbeat
• trouble walking
• changes in your blood pressure.

These are not all the possible side effects of meloxicam and rizatriptan. Tell your healthcare provider if you have any side effect that bothers you or that do not go away. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Adult Dose of Meloxicam/Rizatriptan for Acute Migraines

• 1 tablet (meloxicam 20 mg/ rizatriptan 10 mg) as soon as you start to get a migraine
• Maximum dose: 1 tablet.

Meloxicam and rizatriptan may cause dizziness, weakness, or drowsiness. If you have these symptoms, do not drive a car, use machinery, or do anything that requires you to be alert.

Meloxicam/rizatriptan already contains an NSAID, meloxicam. Avoid taking with other medications that may also contain an NSAID, such as:

• Pain medications (ibuprofen, naproxen)
• Cold and flu medicines
• Fever reducers
• Aspirin (can increase bleeding risk).

Tell your healthcare provider about all of the medicines you take, including prescription or over-the-counter medicines, vitamins, or herbal supplements. Meloxicam and rizatriptan, and other medicines may affect each other, causing side effects or changing the way the medicine works. Do not start taking any new medicine without talking to your healthcare provider first. Especially tell your healthcare provider if you take:

• Propranolol containing medicines such as Inderal, Inderal LA, or InnoPran XL
• Medicines used to help your mood, including SSRIs or SNRIs.
• Aspirin or NSAIDs, such as ibuprofen, diclofenac, or celecoxib
• Any anticoagulant medicines

Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

Store at room temperature between 68°F to 77°F (20°C to 25°C)

Safely discard outdated or unused medicine

Keep out of reach of children

Meloxicam/rizatriptan is made under the brand name Symbravo by Axsome Therapeutics, Inc., New York, NY 10007.

Only available under the brand name Symbravo.

Active ingredients: meloxicam and rizatriptan.

Inactive ingredients (Symbravo): colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose, partially hydrolyzed polyvinyl alcohol, polyethylene glycol, povidone, pregelatinized starch, sodium bicarbonate, sulfobutyl-ether-ß-cyclodextrin sodium, talc, and titanium dioxide.

Each tablet contains 20 mg of meloxicam and 10 mg of rizatriptan.