GALCANEZUMAB-GNLM: 26,722 Adverse Event Reports & Safety Profile
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26,722
Total FAERS Reports
66 (0.2%)
Deaths Reported
681
Hospitalizations
26,722
As Primary/Secondary Suspect
57
Life-Threatening
249
Disabilities
Prescription
Status
FDA Application: 761063 ·
First Report: 20020901 · Latest Report: 20250925
What Are the Most Common GALCANEZUMAB-GNLM Side Effects?
#1 Most Reported
Injection site pain
6,622 reports (24.8%)
#2 Most Reported
Underdose
2,909 reports (10.9%)
#3 Most Reported
Migraine
2,612 reports (9.8%)
All GALCANEZUMAB-GNLM Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Injection site pain | 6,622 | 24.8% | 0 | 30 |
| Underdose | 2,909 | 10.9% | 0 | 14 |
| Migraine | 2,612 | 9.8% | 0 | 94 |
| Headache | 2,104 | 7.9% | 1 | 51 |
| Drug ineffective | 1,610 | 6.0% | 0 | 23 |
| Product dose omission issue | 1,591 | 6.0% | 0 | 24 |
| Injection site haemorrhage | 1,415 | 5.3% | 0 | 7 |
| Accidental underdose | 1,064 | 4.0% | 0 | 1 |
| Injection site erythema | 1,052 | 3.9% | 0 | 8 |
| Injection site pruritus | 774 | 2.9% | 0 | 6 |
| Injection site swelling | 774 | 2.9% | 0 | 2 |
| Incorrect dose administered | 728 | 2.7% | 0 | 4 |
| Injection site reaction | 694 | 2.6% | 0 | 8 |
| Alopecia | 672 | 2.5% | 0 | 6 |
| Injection site bruising | 620 | 2.3% | 0 | 5 |
| Nausea | 601 | 2.3% | 1 | 34 |
| Weight increased | 595 | 2.2% | 0 | 6 |
| Therapeutic response shortened | 592 | 2.2% | 0 | 4 |
| Constipation | 573 | 2.1% | 1 | 22 |
| Fatigue | 534 | 2.0% | 0 | 17 |
Who Reports GALCANEZUMAB-GNLM Side Effects? Age & Gender Data
Gender: 87.6% female, 12.4% male. Average age: 47.4 years. Most reports from: US. View detailed demographics →
Is GALCANEZUMAB-GNLM Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2002 | 1 | 0 | 0 |
| 2003 | 1 | 0 | 0 |
| 2006 | 1 | 0 | 0 |
| 2014 | 1 | 0 | 0 |
| 2017 | 4 | 0 | 2 |
| 2018 | 140 | 1 | 5 |
| 2019 | 1,762 | 3 | 75 |
| 2020 | 1,852 | 3 | 60 |
| 2021 | 1,300 | 6 | 72 |
| 2022 | 947 | 2 | 59 |
| 2023 | 743 | 7 | 53 |
| 2024 | 936 | 4 | 47 |
| 2025 | 715 | 1 | 30 |
What Is GALCANEZUMAB-GNLM Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 13,345 |
| Migraine | 11,124 |
| Migraine prophylaxis | 1,066 |
| Cluster headache | 684 |
| Headache | 293 |
| Migraine with aura | 56 |
| Migraine without aura | 48 |
| Vestibular migraine | 39 |
| Hemiplegic migraine | 23 |
| Trigeminal neuralgia | 16 |
GALCANEZUMAB-GNLM vs Alternatives: Which Is Safer?
GALCANEZUMAB-GNLM vs GALLIUM GA-OZETOTIDE
GALCANEZUMAB-GNLM vs GALSULFASE
GALCANEZUMAB-GNLM vs GAMMAGARD LIQUID
GALCANEZUMAB-GNLM vs GANAXOLONE
GALCANEZUMAB-GNLM vs GANCICLOVIR
GALCANEZUMAB-GNLM vs GANIRELIX
GALCANEZUMAB-GNLM vs GATIFLOXACIN
GALCANEZUMAB-GNLM vs GEFITINIB
GALCANEZUMAB-GNLM vs GELATIN
GALCANEZUMAB-GNLM vs GEMCITABINE
Official FDA Label for GALCANEZUMAB-GNLM
Official prescribing information from the FDA-approved drug label.