Gepant Adverse Events Chart
Posted on August 15 2024,
CGRP Antagonist Adverse Event Comparison
| Adverse Event Category | Rimegepant (Nurtec ODT) | Atogepant (Qulipta) | Ubrogepant (Ubrelvy) | Zavegepant (Zavzpret) |
|---|---|---|---|---|
| Gastrointestinal (Stomach and digestive system) | - Highest severity of nausea - Moderate incidence of constipation - Reports of abdominal pain |
- Most frequent overall gastrointestinal issues - Highest prominence of constipation - Reports of decreased appetite |
- Less prominent than others - Some reports of nausea and vomiting - Occasional abdominal discomfort |
- Moderate nausea (4% vs 1% placebo) - Taste disorders most common (18% vs 4% placebo) - Reduced systemic GI exposure from nasal delivery |
| Skin and Subcutaneous Tissue | - Most frequent rash and pruritus (itching) - Highest severity of alopecia (hair loss) - Reports of urticaria (hives) |
- Secondary severity of alopecia - Some reports of rash and pruritus - Occasional skin hypersensitivity (increased skin sensitivity) |
- Less prominent than others - Few reports of rash and pruritus - Rare cases of angioedema |
- Hypersensitivity reactions (<1%) - Facial swelling and urticaria documented - No increased dermatologic risk from nasal route |
| Cardiac | - Strongest overall cardiac adverse events signal - Reports of palpitations - Some cases of chest discomfort |
- Strong signals for cardiac flutter (irregular heartbeat) - Reports of tachycardia (rapid heart rate) - Some cases of hypertension |
- Comparable rates to others - Occasional reports of chest pain - Few cases of bradycardia (slow heart rate) |
- No serious cardiac events in trials - Post-marketing hypertension signal - New-onset or worsening hypertension within 7 days |
| Musculoskeletal and Connective Tissue | - Less prominent than others - Some reports of myalgia (muscle pain) - Occasional arthralgia (joint pain) |
- Moderate reports of back pain - Some cases of muscle spasms - Occasional reports of joint stiffness |
- Most positive signals for skeletal muscle adverse events - Increased signals for muscle tightness and neck pain - Reports of muscle weakness |
- Back pain most common (5.3%) - Minimal musculoskeletal impact - No specific joint or muscle patterns |
| Raynaud's Phenomenon (Poor blood flow to fingers and toes) | - Strongest signal - More frequent reports of cold extremities - Cases of color changes in fingers/toes |
- Secondary signal strength - Some reports of tingling in extremities - Occasional numbness in fingers/toes |
- Least prominent - Rare reports of Raynaud's-like symptoms - Few cases of sensitivity to cold |
- Critical class-wide safety concern - Median onset 1.5 days post-dosing - FDA mandatory warnings implemented |
| Hepatobiliary (Liver-related) | - Scarce reports across all four gepants - Severe AEs detected in clinical trials, not in post-marketing data - Zavzpret shows no hepatotoxicity signals (major advancement from telcagepant) - ALT/AST elevations in 2-2.6% of patients across all gepants - Continued monitoring recommended for all gepants |
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Data sources: VigiAccess and FDA Adverse Event Reporting System (FAERS) databases up to March 31, 2024. Zavzpret data includes post-marketing surveillance through 2025.
Note: This chart summarizes key findings and does not represent a comprehensive list of all adverse events. The frequency and severity of adverse events may vary among individuals.
Key Updates: Zavzpret data reflects both clinical trial results and emerging post-marketing safety signals, including new FDA label warnings for Raynaud's phenomenon and hypertension monitoring requirements.
Original study source | Updated with Zavzpret comprehensive safety analysis
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