Zavegepant: Uses, Side Effects, Dosage - Drugvu

ℹ️ Compiled from public regulatory records · Last regulator revision: December 26, 2025🚩 Report this page

Zavegepant

Calcitonin Gene-Related Peptide (Cgrp) Antagonists

Sold as ZAVZPRET

US FDA

Drug class: Calcitonin Gene-Related Peptide (Cgrp) Antagonists
Availability: Prescription only
Routes: Nasal
Markets covered: 1
Products on record: 1
FDA reports (12 mo): 175

N02CDCalcitonin Gene-Related Peptide (Cgrp) Antagonists

Overview

Zavegepant is an active pharmaceutical ingredient in the Calcitonin Gene-Related Peptide (Cgrp) Antagonists group (N02CD). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.

Regulatory status by market

Market	Regulator	Products	Last revision
US United States	FDA	1	December 26, 2025

USUnited States· FDA

1 product

Uses

USOfficial regulatory label· revised December 26, 2025[1]

1 INDICATIONS AND USAGE ZAVZPRET is indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use ZAVZPRET is not indicated for the preventive treatment of migraine. ZAVZPRET is a calcitonin gene-related peptide receptor antagonist indicated for the acute treatment of migraine with or without aura in adults.
( 1 ) Limitations of Use ZAVZPRET is not indicated for the preventive treatment of migraine. ( 1 )

How to take

Sources & citations

[1]FDA DailyMed · 1191475f-e999-49… · revised December 26, 2025 [PDF]
[2]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.

Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.

Side effects & warnings

USOfficial regulatory label· Adverse reactions· revised December 26, 2025[1]

3) ] Most common adverse reactions (at least 2% of patients treated with ZAVZPRET and greater than placebo) were taste disorders, nausea, nasal discomfort, and vomiting. 1 ) To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc.
gov/medwatch . 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.
The safety of ZAVZPRET for the acute treatment of migraine in adults has been evaluated in two randomized, double-blind, placebo-controlled trials (Study 1 and Study 2) in patients with migraine who received one 10 mg dose of ZAVZPRET nasal spray (N=1023) or placebo (N=1056) [see Clinical Studies (14) ] .
Approximately 83% were female, 81% were White, 20% were Hispanic or Latino, and 15% were Black. The mean age at study entry was 41 years (range 18-79 years of age). Adverse reactions in Study 1 and 2 are shown in Table 1. 1) ]. Long-term safety was assessed in an open-label extension study.
That study evaluated 603 patients, dosing intermittently for up to one year, including 360 patients who were exposed to ZAVZPRET 10 mg for at least 6 months, and 298 who were exposed for at least one year, all of whom treated an average of at least two migraine attacks per month.
2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of ZAVZPRET. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
3) ]

USOfficial regulatory label· Warnings and precautions· revised December 26, 2025[1]

5 WARNINGS AND PRECAUTIONS • Hypersensitivity Reactions: If a serious hypersensitivity reaction occurs, discontinue ZAVZPRET and initiate appropriate therapy. Hypersensitivity reactions including anaphylaxis, facial swelling, and urticaria, have occurred with ZAVZPRET.
1 ) • Hypertension: New-onset or worsening of pre-existing hypertension may occur. 2 ) • Raynaud’s Phenomenon: New-onset or worsening of pre-existing Raynaud’s phenomenon may occur. 1 Hypersensitivity Reactions Serious hypersensitivity reactions, including anaphylaxis, facial swelling, and urticaria, have occurred in patients treated with ZAVZPRET.
2) ]. 2 Hypertension Development of hypertension and worsening of pre-existing hypertension have been reported following the use of CGRP antagonists in the postmarketing setting. Some of the patients receiving a CGRP antagonist who developed new-onset hypertension had risk factors for hypertension.
There were cases requiring initiation of pharmacological treatment for hypertension and, in some cases, hospitalization. Hypertension may occur at any time during treatment, but was most frequently reported within 7 days of therapy initiation.
The CGRP antagonist was discontinued in many of the reported cases. Monitor patients treated with ZAVZPRET for new-onset hypertension or worsening of pre-existing hypertension, and consider whether discontinuation of ZAVZPRET is warranted if evaluation fails to establish an alternative etiology or blood pressure is inadequately controlled.
3 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. 5 days following dosing.
Many of the cases reported serious outcomes, including hospitalizations and disability, generally related to debilitating pain. In most reported cases, discontinuation of the CGRP antagonist resulted in resolution of symptoms. ZAVZPRET should be discontinued if signs or symptoms of Raynaud’s phenomenon develop, and 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.

This is not medical advice. Consult a qualified healthcare professional.

Overview

Regulatory status by market

USUnited States· FDA

Drugs in the same class

Sources & citations