What the label lists and what reports show
Garadacimab side effects
Garadacimab's FDA label: “Most common adverse reactions (incidence ≥ 7%) are nasopharyngitis and abdominal pain.” FAERS holds 507 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 stress (46 reports).
- No generic listed
Check it at the source: the garadacimab FDA label on DailyMed (effective June 30, 2025); 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 ANDEMBRY?The most common side effects of ANDEMBRY include: redness, itchiness, and bruising (injection site reactions) stomach (abdominal) pain runny or stuffy nose, sneezing, watery eyes (nasopharyngitis) Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of ANDEMBRY. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Source: FDA drug label, CSL, effective June 30, 2025 (SPL set 07b0b671-db81-49f0-a402-0c0219db7fa2), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (incidence ≥ 7%) are nasopharyngitis and abdominal pain.
From the label: adverse reactions, continuedMost common adverse reactions (incidence ≥ 7%) are nasopharyngitis and abdominal pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact CSL Behring at 1-866-915-6958 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 to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of ANDEMBRY reflects the exposure in a total of 164 adult and pediatric patients aged 12 years and older with hereditary angioedema (HAE) from a placebo-controlled study, VANGUARD [see Clinical Studies (14) ], and an open-label clinical study. Among the 164 patients who received at least one dose of ANDEMBRY 200 mg subcutaneously, 153 (93%) patients were exposed for at least one year. The median duration of ANDEMBRY treatment was 2.6 years. The safety data below is based on the 6-month placebo-controlled study (VANGUARD), in which ANDEMBRY 400 mg was administered subcutaneously as a loading dose followed by 200 mg (N=39) every month in patients with HAE. Demographics of the patients in this study are summarized in Clinical Studies [see Clinical Studies (14) ]. …
Source: FDA drug label, CSL, effective June 30, 2025 (SPL set 07b0b671-db81-49f0-a402-0c0219db7fa2), via openFDA; the full label on DailyMed
What do FAERS reports show?
507 reports list garadacimab among the medicines taken, each a report of something that happened, not proof the medicine caused it; 3 are coded as a death and 127 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 17 reactions below, 3 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
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Garadacimab: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions