AJOVY FDA MedWatch Direct Reports Summary

These tables and charts are created from 920 voluntary U.S. reports for AJOVY (FREMANEZUMAB-VFRM) reported by individuals to the FDA via the MedWatch Reporting System from 2004 through April 28, 2026.

For a summary of adverse events including mandatory reports submitted by pharmaceutical companies (all countries and all reporter types) to the FAERS database, View FDA FAERS AJOVY Report.

Top Adverse Effects Associated with AJOVY (from U.S. FDA Medwatch Reports)

	Side Effect	# of FDA Reports
1	HAIR LOSS	84
2	FATIGUE	70
3	JOINT PAIN	68
4	NAUSEA	64
5	CONSTIPATION	63
6	DIZZINESS	54
7	INJECTION SITE REDNESS	53
8	INJECTION SITE ITCHING	52
9	MIGRAINE	52
10	ITCHING	52
11	HEADACHE	50
12	ANXIETY	47
13	WEIGHT INCREASED	46
14	INJECTION SITE SWELLING	45
15	DRUG INEFFECTIVE	44
16	INSOMNIA	41
17	INJECTION SITE PAIN	35
18	RASH	34
19	SHORTNESS OF BREATH	33
20	PALPITATIONS	31
21	MUSCLE PAIN	30
22	HIVES	30
23	DEPRESSION	28
24	INJECTION SITE RASH	28
25	INJECTION SITE REACTION	28

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AJOVY Total Medwatch Safety Reports by Patient Sex

Male	Female	Unknown	Total
65	773	82	920

Medwatch Reporter Type	Count
Consumer	574
Physician	16
Pharmacist	151
Other Health Professional	146

Top Indications

Migraine
Product used for unknown indication
Migraine prophylaxis
Migraine without aura
Migraine with aura

Type of Outcome Reported
Serious: 537
Not Serious: 383
Note: A serious outcome means the adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition.

Suspected Role
Primary Suspect: 920
Concomitant Drugs: 466
Note: A single MedWatch report can list more than one drug. This summary includes AJOVY identified as the suspect drug or as a concomitantly taken drug.

FDA Safety-Related Labeling Changes

AJOVY (FREMANEZUMAB-VFRM) Biological Drug:
FDA Safety-related Labeling Changes

High blood pressure can develop or worsen. Warns of Raynaud’s phenomenon (a type of circulation problem); added clinical trials data for pediatric use

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For serious adverse events, report them to the FDA by contacting the drug manufacturer or report directly through the MedWatch voluntary reporting form.

NOTES

This report, created by AskaPatient.com, is derived from U.S. drug-related adverse event cases that were reported directly to the FDA using the voluntary MedWatch online or paper reporting system. MedWatch is the voluntary FDA system for consumers, physicians, and others to directly report adverse reactions. The Medwatch initiative was launched in 1993 as a voluntary reporting program for consumers, physicians and other healthcare practitioners.

After processing the received forms, the FDA adds the MedWatch reports to the FDA Adverse Events Reporting System(or FAERS database.) Click here for the complete FAERS report summary, which includes mandatory reports submitted by pharmaceutical companies (worldwide) combined with the MedWatch reports. MedWatch Reports only represent about 5% of the FAERS database. For more, read "Does the FDA's Rapidly Growing Database of Adverse Events Improve Drug Safety?"

The data in this report was obtained from Open FDA. Data was last updated to include reports through January 27, 2026. The reactions, side effects, or "adverse events," represent up to the 20 most frequently occuring events in the database for a drug related to the event.

Open FDA states that it only includes the most recent version of a case report. It also adds the disclaimer: "Do not rely on Open FDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated."

FDA uses the "MedDRA" classification system to describe reported adverse reactions. MedDRA is a standardized medical terminology that facilitates sharing of regulatory information internationally. In some cases, "patient friendly" terms for the layman designated by MedDRA have been substituted for medical jargon. Please contact us with questions about this report.