What the label lists and what reports show
Rimegepant side effects
Rimegepant's FDA label: “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).” FAERS holds 12,599 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is nausea (1,176 reports).
- No generic listed
Check it at the source: the rimegepant FDA label on DailyMed (effective June 4, 2026, Pfizer Laboratories Div Pfizer Inc); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of NURTEC ODT?NURTEC ODT may cause serious side effects including: • Allergic reactions. Allergic reactions, including trouble breathing and rash, can happen after you take NURTEC ODT. This can happen days after you take NURTEC ODT. Call your healthcare provider or get emergency help right away if you have any of the following symptoms, which may be part of an allergic reaction: o Swelling of the face, mouth, tongue, or throat o Trouble breathing o Rash • High blood pressure. High blood pressure or worsening of high blood pressure can happen after you take NURTEC ODT. Contact your healthcare provider if you have an increase in blood pressure. • Raynaud’s phenomenon. A type of circulation problem can worsen or happen after you take NURTEC ODT. Raynaud’s phenomenon can lead to your fingers or toes feeling numb, cool, or painful, or changing color from pale, to blue, to red. […]
Source: FDA drug label, Pfizer Laboratories Div Pfizer Inc, effective June 4, 2026 (SPL set 9ef08e09-1098-35cc-e053-2a95a90a3e1d), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe 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).
From the label: adverse reactions, continuedThe 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. ( 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) ]. …
Source: FDA drug label, Pfizer Laboratories Div Pfizer Inc, effective June 4, 2026 (SPL set 9ef08e09-1098-35cc-e053-2a95a90a3e1d), via openFDA; the full label on DailyMed
What do FAERS reports show?
12,599 reports list rimegepant among the medicines taken, each a report of something that happened, not proof the medicine caused it; 109 are coded as a death and 708 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2022 (3,581, against a median of 675 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens. Of the 19 reactions below, 4 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Rimegepant: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions