[At the time of this publication, updates to the FDA’s Drug Safety Database appear to be stalled. This is one of the last updates we were able to collect. To learn more about the reasons behind the delay, see our article: Medication Safety Updates from the FDA Delayed]
Welcome to the FDA Side Effects Update. This series is designed to keep you informed about the latest safety advisories and newly documented side effects of your medications. In this installment, we’re highlighting safety updates concerning Aimovig, Ajovy, Emgality, Nurtec ODT, Qulipta, Ubrelvy, and Zavspret.
How to Read This Report
This report is prepared using the most recent information posted in the SrLC database. It highlights recent safety labeling changes. It includes only newly reported side effects and safety information; additional side effects and warnings will appear on the drug label. Not all recent changes to the SrLC database or the label may be listed here. For all changes and the complete list of warnings and side effects, please click on the drug label link.
Each of the items (approval and update dates, drug names, etc.) contained in this report are obtained from the SrLC. The side effects and medication descriptions are simplified and made
clearer, if needed. Sometimes, additional sources, like a medical dictionary, may be used to translate technical medical phrases. Other sources (company news, FDA press releases, etc.) may be used to learn about some label changes.
FDA Adds Warnings to a Category of Prescription Migraine Drugs
Migraine headaches are recurring headaches that often involve throbbing on one side of the head, nausea, and sensitivity to light. People live with migraine attacks might have headaches for hours or even days. A new class of migraine treatments, known as calcitonin gene-related peptide (CGRP) antagonists, was introduced in 2018 with the FDA approval of the Aimovig injection.
In the second quarter of 2023, the FDA reported that it had received a number of CGRP-related adverse events reports for a condition called “Raynaud’s phenomenon” and that it would “evaluate the need for regulatory action.” Raynaud’s phenomenon is a type of circulation problem that affects your blood vessels and causes fingers or toes to feel numb, cool, or painful. The color of fingers or toes may change to pale, blue, or red.
In August 2024, the FDA began to notify CGRP drug makers that labels should be updated to include warnings about Raynaud’s Phenomenon and, in cases where the warning wasn’t already on the label, the risk of hypertension (high blood pressure) or worsening hypertension.
Aimovig (active ingredient: erenumab-aooe) injection, for subcutaneous use
Initial FDA Approval: 2018
Side Effect Update Date: March 21, 2025
Medication Description: Monthly treatment to prevent migraines.
Updated Side Effects/Safety Information: Warns that Raynaud’s phenomenon (a type of circulation problem) can develop or worsen. Raynaud’s symptoms include fingers or toes feeling numb, cool, or painful. The color of fingers or toes may change to pale, blue, or red. Added information about a pregnancy registry that monitors pregnancy outcomes in women exposed to Aimovig.
FDA Safety Announcement: Aimovig FDA Safety Label Change and Revised Drug Label
Ajovy (active ingredient: fremanezumab-vfrm) injection, for subcutaneous use
Initial FDA Approval: 2018
Side Effect Update Date: March 21, 2025
Medication Description: Monthly or quarterly treatment to prevent migraines.
Updated Side Effects/Safety Information: Warns that hypertension (high blood pressure) can develop or pre-existing hypertension can worsen. Warns that Raynaud’s phenomenon (a type of circulation problem) can develop or worsen. Raynaud’s symptoms include fingers or toes feeling numb, cool, or painful. The color of fingers or toes may change to pale, blue, or red.
FDA Safety Announcement: Ajovy FDA Safety Label Change and Revised Drug Label
Emgality (active ingredient: galcanezumab-gnlm) injection, for subcutaneous use
Initial FDA Approval: 2018
Side Effect Update Date: March 21, 2025
Medication Description: Preventive treatment for migraines; also treats episodic cluster headaches.
Updated Side Effects/Safety Information: A new warning that hypertension (high blood pressure) can develop or pre-existing hypertension can worsen. Another warning states that Raynaud’s phenomenon (a type of circulation problem) can develop or worsen. Raynaud’s symptoms include fingers or toes feeling numb, cool, or painful. The color of fingers or toes may change to pale, blue, or red.
FDA Safety Announcement: Emgality FDA Safety Label Change and Revised Drug Label
Nurtec ODT (active ingredient: rimegepant) orally disintegrating tablets, for sublingual (under the tongue) or oral use
Initial FDA Approval: 2020
Side Effect Update Date: March 21, 2025
Medication Description: Preventative treatment for migraines; also treats migraine with or without aura in adults.
Updated Side Effects/Safety Information: A new warning that hypertension (high blood pressure) can develop or pre-existing hypertension can worsen. The warning states that hypertension may occur at any time during treatment, but was most frequently reported within seven days of therapy initiation. Another added warning that Raynaud’s phenomenon (a type of circulation problem) can develop or worsen. Raynaud’s symptoms include fingers or toes feeling numb, cool, or painful. The color of fingers or toes may change to pale, blue, or red.
FDA Safety Announcement: Nurtec ODT FDA Safety Label Change and Revised Drug Label
Qulipta (active ingredient: atogepant) tablets
Initial FDA Approval: 2021
Side Effect Update Date: March 21, 2025
Medication Description: preventative treatment for migraines in adults.
Updated Side Effects: A new warning that hypertension (high blood pressure) can develop or pre-existing hypertension can worsen. Another added warning that Raynaud’s phenomenon (a type of circulation problem) can develop or worsen. Raynaud’s symptoms include fingers or toes feeling numb, cool, or painful. The color of fingers or toes may change to pale, blue, or red.
Qulipta FDA Safety Label Change and Revised Drug Label
Ubrelvy (active ingredient: ubrogepant) tablets
Initial FDA Approval: 2019
Side Effect Update Date: March 21, 2025
Medication Description: Treats migraine with or without aura in adults; Ubrelvy is not approved for migraine prevention.
Updated Side Effects/Safety Information: A new warning that hypertension (high blood pressure) can develop or pre-existing hypertension can worsen. Another added warning that Raynaud’s phenomenon (a type of circulation problem) can develop or worsen. Symptoms of Raynaud’s include fingers or toes feeling numb, cool, or painful. The color of fingers or toes may change to pale, blue, or red. Raynaud’s symptom onset occurred a median of 1.5 days following dosing.
FDA Safety Announcement: Ubrelvy FDA Safety Label Change and Revised Drug Label
Zavspret: (active ingredient: zavegepant) nasal spray
Initial FDA Approval: 2023
Side Effect Update Date: March 21, 2025
Medication Description: Treats migraine with or without aura in adults. Zavspret is not approved for migraine prevention.
Updated Side Effects/Safety Information: A new warning that hypertension (high blood pressure) can develop or pre-existing hypertension can worsen. An added warning that Raynaud’s phenomenon (a type of circulation problem) can develop or worsen. Symptoms of Raynaud’s include fingers or toes feeling numb, cool, or painful. The color of fingers or toes may change to pale, blue, or red.
FDA Safety Announcement: Zayspret FDA Safety Label Change and Revised Drug Label
