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What the label lists and what reports show

Galcanezumab side effects

Galcanezumab's FDA label: “The most common adverse reactions (incidence ≥2% and at least 2% greater than placebo) in EMGALITY clinical studies were injection site reactions.” FAERS holds 31,311 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is injection site pain (7,524 reports).

  • No generic listed

Check it at the source: the galcanezumab FDA label on DailyMed (effective June 5, 2026); the FDA FAERS public dashboard.

What does the patient leaflet say about side effects?

From the patient leaflet: What are the possible side effects of EMGALITY?

EMGALITY may cause serious side effects, including: Allergic reactions. Allergic reactions, including itching, rash, hives, and trouble breathing, can happen after receiving EMGALITY. This can happen days after using EMGALITY. Call your healthcare provider or get emergency medical help right away if you have any of the following symptoms, which may be part of an allergic reaction: swelling of the face, mouth, tongue, or throat trouble breathing Constipation with serious complications. Severe constipation can happen after receiving EMGALITY. In some cases, people have been hospitalized or needed surgery. Contact your healthcare provider if you have severe constipation or constipation associated with symptoms such as severe or constant belly pain, vomiting, swelling of belly, or bloating. High blood pressure. […]

Source: FDA drug label, Eli Lilly and Company, effective June 5, 2026 (SPL set 33a147be-233a-40e8-a55e-e40936e28db0), via openFDA; the full label on DailyMed

What does the label list?

From the label: adverse reactions

The most common adverse reactions (incidence ≥2% and at least 2% greater than placebo) in EMGALITY clinical studies were injection site reactions.

From the label: adverse reactions, continued

The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions [see Contraindications ( 4 ) and Warnings and Precautions ( 5.1 )] Constipation with Serious Complications [see Warnings and Precautions ( 5.2 )] Hypertension [see Warnings and Precautions ( 5.3 )] Raynaud's Phenomenon [see Warnings and Precautions ( 5.4 )] The most common adverse reactions (incidence ≥2% and at least 2% greater than placebo) in EMGALITY clinical studies were injection site reactions. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in clinical trials of another drug and may not reflect the rates observed in clinical practice. Migraine The safety of EMGALITY has been evaluated in 2586 patients with migraine who received at least one dose of EMGALITY, representing 1487 patient-years of exposure. Of these, 1920 patients were exposed to EMGALITY once monthly for at least 6 months, and 526 patients were exposed for 12 months. …

Source: FDA drug label, Eli Lilly and Company, effective June 5, 2026 (SPL set 33a147be-233a-40e8-a55e-e40936e28db0), via openFDA; the full label on DailyMed

What do FAERS reports show?

31,311 reports list galcanezumab among the medicines taken, each a report of something that happened, not proof the medicine caused it; 85 are coded as a death and 1,122 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 16 reactions below, 5 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

Reports received each year

The 25 most reported reactions

  • Injection Site Pain (named in the label)7,524
  • Migraine (a use or a product term, not a reaction)3,057
  • Underdose (a use or a product term, not a reaction)2,917
  • Headache (a use or a product term, not a reaction)2,448
  • Drug Ineffective (a use or a product term, not a reaction)1,955
  • Product Dose Omission Issue (a use or a product term, not a reaction)1,748
  • Injection Site Haemorrhage1,608
  • Injection Site Erythema (named in the label)1,128
  • Incorrect Dose Administered (a use or a product term, not a reaction)1,069
  • Accidental Underdose (a use or a product term, not a reaction)1,068
  • Nausea826
  • Injection Site Pruritus (named in the label)817
  • Injection Site Swelling809
  • Fatigue767
  • Injection Site Reaction (named in the label)724
  • Alopecia715
  • Injection Site Bruising704
  • Constipation (named in the label)663
  • Therapeutic Response Shortened660
  • Dizziness657
  • Weight Increased652
  • Pain586
  • Incorrect Dose Administered By Device (a use or a product term, not a reaction)577
  • Anxiety551
  • Product Dose Omission (a use or a product term, not a reaction)537

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Galcanezumab: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions