Rimegepant sulfate

What Rimegepant sulfate is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

NURTEC ODT is a calcitonin gene-related peptide receptor antagonist indicated for the: • acute treatment of migraine with or without aura in adults • preventive treatment of episodic migraine in adults 1.1 Acute Treatment of Migraine NURTEC ODT is indicated for the acute treatment of migraine with or without aura in adults. …

— FDA label: Nurtec ODT, Pfizer Laboratories Div Pfizer Inc, effective June 4, 2026. Read the full label on DailyMed →

Label quoted: the one for the most common form (tablet, orally disintegrating, oral), Nurtec ODT, Pfizer Laboratories Div Pfizer Inc; it covers 2 products in the FDA NDC Directory. The side effects, interactions, dosage and pregnancy quotes below come from this same label.

The FDA has 2 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

Boxed warning

A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.

The label quoted above has no boxed warning.

0 of 2 FDA labels for this medicine have a boxed warning.

Rimegepant sulfate side effects

Quoted from the “Adverse Reactions” section of the FDA-approved label. Tell your doctor about any side effect that worries you.

The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling:

• Hypersensitivity Reactions [see Warnings and Precautions (5.1)]
• Hypertension [see Warnings and Precautions (5.2)]
• Raynaud’s Phenomenon [see Warnings and Precautions (5.3)]
• Acute treatment of migraine: the adverse reaction reported in ≥1% of patients treated with NURTEC ODT is nausea.

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(6.1)

• Preventive treatment of episodic migraine: adverse reactions reported in ≥2% for rimegepant and ≥1% higher than placebo are nausea and abdominal pain/dyspepsia. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Acute Treatment of Migraine The safety of NURTEC ODT for the acute treatment of migraine in adults has been evaluated in a randomized, double-blind, placebo-controlled trial (Study 1) in 682 patients with migraine who received one 75 mg dose of NURTEC ODT [see Clinical Studies (14)]. Approximately 85% were female, 74% were White, 21% were Black, and 17% were Hispanic or Latino. The mean age at study entry was 40 years (range 18-75 years of age). Long-term safety was assessed in an open-label extension study using a different oral dosage form of rimegepant. That study evaluated 1,798 patients, dosing intermittently for up to one year, including 1,131 patients who were exposed to rimegepant 75 mg for at least 6 months, and 863 who were exposed for at least one year, all of whom treated an average of at least two migraine attacks per month. The most common adverse reaction in Study 1 was nausea (2% in patients who received NURTEC ODT compared to 0.4% of patients who received placebo). Hypersensitivity, including dyspnea and severe rash, occurred in less than 1% of patients treated with NURTEC ODT [see Contraindications (4) and Warnings and Precautions (5.1)]. Preventive Treatment of Episodic Migraine The safety of NURTEC ODT for the preventive treatment of episodic migraine in adults has been established in a randomized, double-blind, placebo-controlled trial with an open-label extension (Study 2) using a different oral dosage form of rimegepant [see Clinical Studies (14)]. In the 12-week, double-blind treatment period, 370 patients with migraine received one 75 mg dose of rimegepant every other day. Approximately 81% were female, 80% were White, 17% were Black, and 28% were Hispanic or Latino. The mean age at study entry was 41 years (range 18-74 years of age). Long-term safety was assessed in an open-label extension study that included 603 patients who were treated for up to one year. Overall, 527 patients were exposed to rimegepant 75 mg for at least 6 months, and 311 were exposed for at least one year.

— FDA label: Nurtec ODT, Pfizer Laboratories Div Pfizer Inc, effective June 4, 2026. This is part of the section. Read the full label on DailyMed →

Rimegepant sulfate drug interactions

Quoted from the “Drug Interactions” section of the FDA-approved label. Tell your pharmacist about every medicine, vitamin and herbal product you take.

• Strong CYP3A4 Inhibitors: Avoid concomitant administration. (7.1)
• Moderate CYP3A4 Inhibitors: Avoid another dose within 48 hours when administered with a moderate CYP3A4 inhibitor. (7.1)
• Strong and Moderate CYP3A Inducers: Avoid concomitant administration. (7.2)
• Potent Inhibitors of P-gp: Avoid another dose of NURTEC ODT within 48 hours when administered with a potent P-gp inhibitor.

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(7.3) 7.1 CYP3A4 Inhibitors Concomitant administration of NURTEC ODT with strong inhibitors of CYP3A4 results in a significant increase in rimegepant exposure. Avoid concomitant administration of NURTEC ODT with strong inhibitors of CYP3A4 [see Clinical Pharmacology (12.3)]. Concomitant administration of NURTEC ODT with moderate inhibitors of CYP3A4 may result in increased exposure of rimegepant. Avoid another dose of NURTEC ODT within 48 hours when it is concomitantly administered with moderate inhibitors of CYP3A4 [see Clinical Pharmacology (12.3)]. 7.2 CYP3A Inducers Concomitant administration of NURTEC ODT with strong or moderate inducers of CYP3A can result in a significant reduction in rimegepant exposure, which may lead to loss of efficacy of NURTEC ODT. Avoid concomitant administration of NURTEC ODT with strong or moderate inducers of CYP3A [see Clinical Pharmacology (12.3)]. 7.3 P-gp Inhibitors Concomitant administration of NURTEC ODT with potent inhibitors of P-gp (e.g., amiodarone, cyclosporine, lapatinib, quinidine, ranolazine) may result in increased exposure of rimegepant. Avoid another dose of NURTEC ODT within 48 hours when it is concomitantly administered with potent inhibitors of P-gp [see Clinical Pharmacology (12.3)].

— FDA label: Nurtec ODT, Pfizer Laboratories Div Pfizer Inc, effective June 4, 2026. Read the full label on DailyMed →

Rimegepant sulfate dosage

Quoted from the “Dosage and Administration” section of the FDA-approved label. Your own dose is the one your doctor prescribes: do not change it on your own.

• Recommended dosage for acute treatment of migraine: 75 mg taken orally, as needed. (2.1)
• The safety of using more than 18 doses in a 30-day period has not been established. (2.1)
• Recommended dosage for preventive treatment of episodic migraine: 75 mg taken orally every other day. (2.2)
• The maximum dose in a 24-hour period is 75 mg. (2.1)
• NURTEC ODT can be taken with or without food.

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(2.1, 2.2) 2.1 Recommended Dosing for Acute Treatment of Migraine The recommended dose of NURTEC ODT is 75 mg taken orally, as needed. The maximum dose in a 24-hour period is 75 mg. The safety of using more than 18 doses in a 30-day period has not been established. NURTEC ODT can be taken with or without food [see Clinical Pharmacology (12.3)]. 2.2 Recommended Dosing for Preventive Treatment of Episodic Migraine The recommended dosage of NURTEC ODT is 75 mg taken orally every other day, with or without food. 2.3 Administration Information Instruct the patient on the following administration instructions:

• Use dry hands when opening the blister pack.
• Peel back the foil covering of one blister and gently remove the orally disintegrating tablet (ODT). Do not push the ODT through the foil.
• As soon as the blister is opened, remove the ODT and place on the tongue; alternatively, the ODT may be placed under the tongue.
• The ODT will disintegrate in saliva so that it can be swallowed without additional liquid.
• Take the ODT immediately after opening the blister pack. Do not store the ODT outside the blister pack for future use. 2.4 Concomitant Administration with Strong or Moderate CYP3A4 Inhibitors Avoid concomitant administration of NURTEC ODT with strong inhibitors of CYP3A4. Avoid another dose of NURTEC ODT within 48 hours when it is concomitantly administered with moderate inhibitors of CYP3A4 [see Drug Interactions (7.1), Clinical Pharmacology (12.3)]. 2.5 Concomitant Administration with Strong or Moderate CYP3A Inducers Avoid concomitant administration of NURTEC ODT with strong or moderate inducers of CYP3A, which may lead to loss of efficacy of NURTEC ODT [see Drug Interactions (7.2), Clinical Pharmacology (12.3)]. 2.6 Concomitant Administration with Potent Inhibitors of P-gp Avoid another dose of NURTEC ODT within 48 hours when it is concomitantly administered with potent inhibitors of P-gp [see Drug Interactions (7.3), Clinical Pharmacology (12.3)].

— FDA label: Nurtec ODT, Pfizer Laboratories Div Pfizer Inc, effective June 4, 2026. Read the full label on DailyMed →

Rimegepant sulfate in pregnancy

Quoted from the pregnancy part of the FDA-approved label. Ask your doctor before you take any medicine while pregnant or planning a pregnancy.

Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to NURTEC ODT during pregnancy. For more information, healthcare providers or patients are encouraged to contact: 1-877-366-0324, email crgnurtecpregnancyregistry@thermofisher.com, or visit nurtecpregnancyregistry.com. Risk Summary There are no adequate data on the developmental risk associated with the use of NURTEC ODT in pregnant women.

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In animal studies, oral administration of rimegepant during organogenesis resulted in adverse effects on development in rats (decreased fetal body weight and increased incidence of skeletal variations) at exposures greater than those used clinically and which were associated with maternal toxicity (see Data). In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. The estimated rate of major birth defects (2.2 to 2.9%) and miscarriage (17%) among deliveries to women with migraine are similar to rates reported in women without migraine. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Published data have suggested that women with migraine may be at increased risk of preeclampsia and gestational hypertension during pregnancy. Data Animal Data Oral administration of rimegepant (0, 10, 60, or 300 mg/kg/day) to pregnant rats during the period of organogenesis resulted in decreased fetal body weight and an increased incidence of fetal skeletal variations at the highest dose tested (300 mg/kg/day), which was associated with maternal toxicity. Plasma exposures (AUC) at the no-effect dose (60 mg/kg/day) for adverse effects on embryofetal development were approximately 45 times that in humans at the maximum recommended human dose (MRHD) of 75 mg/day. Oral administration of rimegepant (0, 10, 25, or 50 mg/kg/day) to pregnant rabbits during the period of organogenesis resulted in no adverse effects on embryofetal development. The highest dose tested (50 mg/kg/day) was associated with plasma exposures (AUC) approximately 10 times that in humans at the MRHD. Oral administration of rimegepant (0, 10, 25, or 60 mg/kg/day) to rats throughout gestation and lactation resulted in no effects on pre- or postnatal development. The highest dose tested (60 mg/kg/day) was associated with plasma exposures (AUC) approximately 24 times that in humans at the MRHD.

— FDA label: Nurtec ODT, Pfizer Laboratories Div Pfizer Inc, effective June 4, 2026. Read the full label on DailyMed →

When Rimegepant sulfate should not be used

Quoted from the “Contraindications” section of the FDA-approved label.

NURTEC ODT is contraindicated in patients with a history of hypersensitivity reaction to rimegepant, NURTEC ODT, or any of its components. Reactions have included anaphylaxis and delayed serious hypersensitivity [see Warnings and Precautions (5.1)]. Patients with a history of hypersensitivity reaction to rimegepant, NURTEC ODT, or to any of its components. (4)

— FDA label: Nurtec ODT, Pfizer Laboratories Div Pfizer Inc, effective June 4, 2026. Read the full label on DailyMed →

Rimegepant sulfate overdose

Quoted from the “Overdosage” section of the FDA-approved label. If someone may have taken too much, call Poison Help at 1-800-222-1222 (or 911 in an emergency).

There is limited clinical experience with NURTEC ODT overdosage. Treatment of an overdose of NURTEC ODT should consist of general supportive measures including monitoring of vital signs and observation of the clinical status of the patient. No specific antidote for the treatment of rimegepant overdose is available. Rimegepant is unlikely to be significantly removed by dialysis because of high serum protein binding [see Clinical Pharmacology (12.3)].

— FDA label: Nurtec ODT, Pfizer Laboratories Div Pfizer Inc, effective June 4, 2026. Read the full label on DailyMed →

Forms and how it is given

Companies that list this medicine

Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.

• Pfizer Laboratories Div Pfizer Inc2 products
• Sportpharm LLC1 product

FDA approval history

• NDA: New Drug Application: how a new (usually brand-name) medicine is approved.

Shortage status

The FDA drug shortage list does not show these products.

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Recalls

From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.

1. March 15, 2021 · Class II · Terminated · D-0451-2021

   CGMP Deviations: Intermittent exposure to temperature excursion during storage.

   NURTEC ODT (RIMEGEPANT) 75MG 8 BPK; NDC/UPC 72618-3000-2; RX; TABLETS FOR RAPID DISSOLUTION (NOT SUBLINGUAL) — Cardinal Health Inc.

Official identifiers

Next steps

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Sources

1. FDA-approved label on DailyMed (National Library of Medicine) — Nurtec ODT, Pfizer Laboratories Div Pfizer Inc, effective June 4, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
5. Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026

openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →

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