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Nurtec ODT Safety ProfileNurtec ODT Safety ProfileNurtec ODT was generally well tolerated in clinical trials with a low rate of adverse events1 Select Important Safety Information
Contraindications: Hypersensitivity to Nurtec ODT or any of its components.
Warnings and Precautions

Hypersensitivity Reactions: If a serious hypersensitivity reaction occurs, discontinue Nurtec ODT and initiate appropriate therapy. Serious hypersensitivity reactions have included anaphylaxis, dyspnea, and rash and can occur days after administration.
Hypertension: Development of hypertension and worsening of pre-existing hypertension have been reported following the use of CGRP antagonists, including Nurtec ODT, in the postmarketing setting.
Monitor patients for new-onset hypertension or worsening of pre-existing hypertension and consider whether discontinuation is warranted.
Raynaud’s Phenomenon: Development of Raynaud’s phenomenon and recurrence or worsening of pre-existing Raynaud’s phenomenon have been reported in the postmarketing setting following the use of CGRP antagonists, including Nurtec ODT.
If signs or symptoms of Raynaud’s phenomenon develop, discontinue Nurtec ODT. Patients should be evaluated by a healthcare provider if symptoms do not resolve. Patients with a history of Raynaud’s phenomenon should be monitored for and informed about the possibility of worsening or recurrence of signs and symptoms.
Acute treatment safety information

See below for preventive treatment safety information

Pivotal phase 3 acute study2
  • The most common AE with acute treatment in the pivotal trial was nausea (Nurtec ODT 2%; placebo 0.4%)1 
  • Nurtec ODT was not associated with serious AEs2
  • The gepant mechanism of action has not been associated with medication overuse headache3
  • Not contraindicated in patients with stable cardiovascular disease or risk factors1
    • Development of hypertension and worsening of pre-existing hypertension have been reported following the use of CGRP antagonists, including Nurtec ODT, in the postmarketing setting1
    • Contraindicated in patients with a hypersensitivity to rimegepant, Nurtec ODT, or any of its components1
 View acute study designLoading

AE=adverse event; CGRP=calcitonin gene-related peptide.

52-week open-label long-term acute safety study4More than 100,000 doses of Nurtec ODT were administered across 1800 patients5Most AEs reported were mild or moderate in intensity and judged by the investigator to be unrelated to treatment with rimegepant 75 mg4
  • <3% of patients discontinued due to AEs4*
  • 2.6% of patients reported serious AEs4†‡
Serious AEs reported in >1 patient4§
  • Accidental overdose, appendicitis, osteoarthritis, and pulmonary embolism (3 patients each [0.2%])4
  • Constipation, pneumonia, and sepsis (2 patients each [0.1%])4
Serious AEs related to Nurtec ODT4,6
  • 10 (0.6%) serious AEs were considered by the investigator to be related to rimegepant 75 mg (1 possibly related serious AE and 9 unlikely related serious AEs)4,6
  • No deaths were reported in this study7
 View acute study design LoadingEOD=every other day; PRN=as needed.This percentage includes both the PRN and EOD + PRN treatment groups; the overall discontinuation rate due to AEs for the 2 PRN treatment cohorts was 2.6%.4This percentage includes both the PRN and EOD + PRN treatment groups; the overall rate of serious AEs in the PRN treatment cohorts was 2.9%.4Serious AEs considered by the investigator to be possibly (1 serious AE) or unlikely (9 serious AEs) related to study drug were reported in 10 (0.6%) participants. A serious AE was defined as any event that meets any of the following criteria at any dose: death, life-threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect in the offspring of a subject who received rimegepant 75 mg, and others.4,6,8Includes both the PRN and EOD + PRN treatment groups.4AEs associated with Nurtec ODT up to 52 weeks for acute treatment4
Most AEs reported were mild or moderate in intensity and judged by the investigator to be unrelated to treatment with rimegepant 75 mg4
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Preventive treatment safety information over 52 weeksPreventive treatment with every-other-day dosing in the open-label extension study9Adverse reactions reported in ≥2% of patients for rimegepant and ≥1% higher than placebo were nausea and abdominal pain/dyspepsia1
  • 2.8% overall discontinuation rate due to AEs9
  • Long-term safety was assessed in an open-label extension study that included 603 patients who were treated for up to 1 year1
  • Constipation incidence ranged from 1.1% with every-other-day dosing over 12 weeks in the double-blind study to 1.5% with every-other-day plus as-needed use over 52 weeks in the open-label study10
AEs associated with rimegepant 75 mg for preventive treatment in the open-label extension study9Safety profile of long-term treatment with rimegepant 75 mg EOD + PRN9
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Additional considerations for your patients who may benefit from Nurtec ODT
  • No restrictions for patients taking oral contraceptives or antidepressants1,11
  • ~11-hour half-life may facilitate rapid reduction or elimination of drug exposure, which may be helpful in case of an AE or when considering family planning1,12
  • Lactation study demonstrated low breast milk transfer, with a relative infant dose of <1% of the maternal weight-adjusted dose and a milk to plasma ratio of 0.201
    • There are no data on the effects of rimegepant 75 mg on a breastfed infant or on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Nurtec ODT and any potential adverse effects on the breastfed infant from Nurtec ODT or from the underlying maternal condition1
Nurtec ODT. Package insert. Pfizer Inc.Have samples of Nurtec ODT delivered to your office Get samples LoadingReferences:Nurtec ODT. Package insert. Pfizer Inc.Croop R, Goadsby PJ, Stock DA, et al. Efficacy, safety, and tolerability of rimegepant orally disintegrating tablet for the acute treatment of migraine: a randomised, phase 3, double-blind, placebo-controlled trial. Lancet. 2019;394(10200):737-745.Ailani J, Burch RC, Robbins MS; Board of Directors of the American Headache Society. The American Headache Society Consensus Statement: update on integrating new migraine treatments into clinical practice. Headache. 2021;61(7):1021-1039.Croop R, Berman G, Kudrow D, et al. A multicenter, open-label long-term safety study of rimegepant for the acute treatment of migraine. Cephalalgia. 2024;44(4):1-11.Croop R, Berman G, Kudrow D, et al. Long-term safety of rimegepant 75 mg for the acute treatment of migraine (study 201) (4829). Neurology. 2020;94(suppl 15).Supplement to: Croop R, Berman G, Kudrow D, et al. A multicenter, open-label long-term safety study of rimegepant for the acute treatment of migraine. Cephalalgia. 2024;44(4):1-11.True D, Mullin K, Croop R. Safety of rimegepant in adults with migraine and cardiovascular risk factors: analysis of a multicenter, long-term, open-label study. Pain Ther. 2024;13(5):1203-1218.Data on file. BHV3000-303 Clinical Protocol. Pfizer Inc.Kudrow D, Croop RS, Thiry A, Lipton RB. A 52-week open-label extension study to evaluate the safety and efficacy of oral rimegepant for the preventive treatment of migraine. Headache. Published online June 30, 2025. doi:10.1111/head.15002Data on file. BHV3000-305-065. Pfizer Inc.Baskin SM, Buse DC, Jensen CM, et al. Rimegepant 75 mg is safe and well tolerated for the acute treatment of migraine in adults using selective serotonin reuptake inhibitors and other antidepressants: results from a long-term open-label safety study (study 201). Poster presented at: American Headache Society 62nd Annual Scientific Meeting; June 13, 2020; virtual.Croop R, Lipton RB, Kudrow D, et al. Oral rimegepant for preventive treatment of migraine: a phase 2/3, randomised, double-blind, placebo-controlled trial. Lancet. 2021;397(10268):51-60. Learn more about preventive treatment View the data Loading Learn more about acute treatment View the data Loading

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PP-NNT-USA-4379
INDICATIONSNurtec ODT is indicated in adults for the:
  • acute treatment of migraine with or without aura
  • preventive treatment of episodic migraine

Please click here for full Prescribing Information.
Important Safety Information Contraindications: Hypersensitivity to Nurtec ODT or any of its components. Warnings and Precautions Hypersensitivity Reactions: If a serious hypersensitivity reaction occurs, discontinue Nurtec ODT and initiate appropriate therapy. Serious hypersensitivity reactions have included anaphylaxis, dyspnea, and rash and can occur days after administration. Hypertension: Development of hypertension and worsening of pre-existing hypertension have been reported following the use of CGRP antagonists, including Nurtec ODT, in the postmarketing setting.Monitor patients for new-onset hypertension or worsening of pre-existing hypertension and consider whether discontinuation is warranted. Raynaud’s Phenomenon: Development of Raynaud’s phenomenon and recurrence or worsening of pre-existing Raynaud’s phenomenon have been reported in the postmarketing setting following the use of CGRP antagonists, including Nurtec ODT.If signs or symptoms of Raynaud’s phenomenon develop, discontinue Nurtec ODT. Patients should be evaluated by a healthcare provider if symptoms do not resolve. Patients with a history of Raynaud’s phenomenon should be monitored for and informed about the possibility of worsening or recurrence of signs and symptoms. Adverse Reactions: The most common adverse reactions for Nurtec ODT vs placebo were nausea (2.7% vs 0.8%) and abdominal pain/dyspepsia (2.4% vs 0.8%). Drug Interactions: Avoid concomitant administration of Nurtec ODT with strong inhibitors of CYP3A4 or strong or moderate inducers of CYP3A. Avoid another dose of Nurtec ODT within 48 hours when it is administered with moderate inhibitors of CYP3A4 or potent inhibitors of P-gp. Use in Specific Populations: Pregnancy: It is not known if Nurtec ODT can harm an unborn baby.
Lactation: The transfer of rimegepant into breast milk is low (<1%). Hepatic impairment: Avoid use of Nurtec ODT in persons with severe hepatic impairment. Renal impairment: Avoid use in patients with end-stage renal disease.IndicationsNurtec ODT is indicated in adults for the:
  • acute treatment of migraine with or without aura
  • preventive treatment of episodic migraine

Please click here for full Prescribing Information.