FDA Adverse Events Reports (FAERS) Summary for AJOVY

These tables and charts are based on 10,985 total reports for AJOVY (FREMANEZUMAB-VFRM) received by the FDA Adverse Event Reporting System (FAERS) from 2004 through April 28, 2026.

This FAERS total includes 10,065 pharmaceutical company-submitted and non-U.S. FAERS reports and 920 U.S. consumer or healthcare provider-submitted MedWatch reports. For a separate summary of the 920 U.S. reports filed via the FDA MedWatch voluntary reporting system, view our FDA MedWatch AJOVY summary report. (See notes section below for explanation of FDA’s mandatory and voluntary reporting system.)

Top 20 Adverse Effects Associated with AJOVY (reported in FAERS Database)

	Side Effect	# of FDA Reports
1	ACCIDENTAL EXPOSURE TO PRODUCT	1437
2	INJECTION SITE PAIN	1279
3	MIGRAINE	986
4	DRUG INEFFECTIVE	888
5	HEADACHE	718
6	INJECTION SITE REDNESS	634
7	DEVICE LEAKAGE	559
8	INJECTION SITE ITCHING	482
9	DEVICE MALFUNCTION	478
10	FATIGUE	471
11	NAUSEA	462
12	INJECTION SITE SWELLING	432
13	DRUG DOSE OMISSION BY DEVICE	415
14	INCORRECT DOSE ADMINISTERED BY DEVICE	387
15	DIZZINESS	375
16	PRODUCT DOSE OMISSION ISSUE	364
17	ITCHING	343
18	INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION	325
19	PAIN	306
20	RASH	304
21	CONSTIPATION	296
22	DEVICE ISSUE	296
23	INJECTION SITE REACTION	296
24	HAIR LOSS	293
25	JOINT PAIN	282
26	NEEDLE ISSUE	275
27	INCORRECT DOSE ADMINISTERED	273
28	INJECTION SITE RASH	271
29	ANXIETY	265
30	MALAISE	251
31	SHORTNESS OF BREATH	237
32	WRONG TECHNIQUE IN PRODUCT USAGE PROCESS	237
33	DEVICE DELIVERY SYSTEM ISSUE	236
34	PRODUCT USE ISSUE	230
35	FEELING ABNORMAL	221
36	INJECTION SITE MASS	221
37	HIVES	219
38	WEIGHT INCREASED	205
39	INJECTION SITE HAEMORRHAGE	203
40	HYPERSENSITIVITY	196
41	DEVICE DIFFICULT TO USE	195
42	INJECTION SITE BRUISING	194
43	INSOMNIA	189
44	VOMITING	187
45	WRONG TECHNIQUE IN DEVICE USAGE PROCESS	185
46	PALPITATIONS	173
47	INJECTION SITE URTICARIA	172
48	INJECTION SITE EXTRAVASATION	166
49	OFF LABEL USE	151
50	SKIN REDNESS	148
51	COVID-19	147
52	DIARRHEA	147
53	CHEST PAIN	144
54	PRODUCT STORAGE ERROR	144
55	DRUG EFFECT INCOMPLETE	144
56	DEPRESSION	143
57	PAIN IN EXTREMITY	133
58	DEVICE DEFECTIVE	129
59	LACK OF STRENGTH AND ENERGY (ASTHENIA)	127
60	INJECTION SITE WARMTH	127
61	THERAPEUTIC RESPONSE SHORTENED	125
62	INJECTION SITE DISCHARGE	124
63	PINS AND NEEDLES	124
64	MUSCLE PAIN	118
65	ILLNESS	115
66	FALL	114
67	NUMBNESS	111
68	DRUG HYPERSENSITIVITY	110
69	HIGH BLOOD PRESSURE	110
70	CHEST DISCOMFORT	105
71	ADVERSE EVENT	103
72	ABDOMINAL PAIN UPPER	100
73	LOWER LIMBS SWELLING	99
74	PRODUCT USE IN UNAPPROVED INDICATION	99
75	MUSCLE SPASMS	98
76	FAINTING	98
77	TREMOR	98
78	BACK PAIN	96
79	SEIZURE	95
80	VISUAL IMPAIRMENT	94
81	VISION BLURRED	92
82	SWELLING	89
83	ADVERSE DRUG REACTION	88
84	LOSS OF CONSCIOUSNESS	88
85	VERTIGO	87
86	DROWSINESS	86
87	WEIGHT DECREASED	86
88	FEVER	85
89	ABDOMINAL PAIN	84
90	COUGH	84
91	NECK PAIN	83
92	STROKE	82
93	DEATH	81
94	HEART RATE INCREASED	81
95	ABDOMINAL DISTENSION	80
96	BLOOD PRESSURE INCREASED	78
97	THERAPEUTIC PRODUCT EFFECT DECREASED	77
98	ABDOMINAL DISCOMFORT	76
99	INJECTION SITE INDURATION	74
100	FACIAL SWELLING	74

Latest Known Outcomes for Reactions Reported for AJOVY

	Latest Known Outcome for Reported Reactions	Number of Cases
1	Unknown Outcome	8457
2	Patient recovered	1484
3	Patient has not recovered/symtoms have not resolved	1476
4	Patient is recovering/symptoms resolving	664
5	Patient died	79
6	Patient has recovered but has consequent health issues	53

Search all MedWatch and FAERS by keyword:

AJOVY Total Reports

Male	Female	Unknown	Total
1103	8669	1213	10,985

Top Countries Reporting

	Country	Number of Reports
1	United States	9051
2	United Kingdom	594
3	Canada	353
4	Germany	97
5	EU	97
6	Japan	91
7	Netherlands	81
8	Australia	77
9	Norway	52
10	Brazil	51

Outcomes for Reports

Serious: 3549
Not Serious: 7433
Note: A serious outcome means the adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition.

Top Indications

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

Top Companies Reporting

TEVA

Safety-Related FDA Updates

FDA Approval Date: 2018-09-14

AJOVY (FREMANEZUMAB-VFRM) Biological Drug:
High blood pressure can develop or worsen. Warns of Raynaud’s phenomenon (a type of circulation problem); added clinical trials data for pediatric use Safety-related Labeling Changes

Have experience (good or bad) with AJOVY? Rate AJOVY at Ask a Patient.

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 the cases for AJOVY reported to the United States Food and Drug Administration (FDA) FDA Safety Information and Adverse Event Reporting System (FAERS) and obtained from Open FDA. Data was last updated with reports received through April 28, 2026.

This summary includes ALL reports where the drug is a "primary OR secondary OR suspected interacting" drug. Typically, reports are filed for the most serious type or "event" and do not represent incidental or minor side effects. The majority of these reports are mandatory reports submitted by pharmaceutical companies, who receive complaints from consumers. 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. This report also features counts of latest known outcomes associated with reported side effects, but does not provide the specific outcomes for specific adverse events.

Adverse Event Reports are submitted to the FAERS database by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers). Health care providers such as doctors (voluntary reporting), and patients themselves (voluntary reporting) report to the FDA directly through the MedWatch program. Those MedWatch reports are coded and included in the FAERS database. This report mainly consists of the mandatory reports, because the MedWatch reports are a small percentage (3 - 5%) of total reports. Link to the MedWatch summary report at the top of the page for a summary of the directly reported (voluntary) adverse events for this drug.The number of reports included here might differ somewhat from the number of reports in the downloadable quarterly FAERS reports and in the online FAERS dashboard, due to lags in reporting, drug name differences, duplicates, and other factors. Open FDA states that it only includes the most recent version of a case report. It also adds the disclaimer: "Do not rely on openFDA 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 or comments about this report.