What the label lists and what reports show
Idarucizumab side effects
Idarucizumab's FDA label: “In healthy volunteers, the most frequently reported adverse reactions in ≥5% of subjects treated with idarucizumab was headache.” FAERS holds 1,428 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 haemorrhage (119 reports).
- No generic listed
Check it at the source: the idarucizumab FDA label on DailyMed (effective January 23, 2024, Boehringer Ingelheim Pharmaceuticals, Inc.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsIn healthy volunteers, the most frequently reported adverse reactions in ≥5% of subjects treated with idarucizumab was headache.
From the label: adverse reactions, continuedThe following serious adverse reactions are described in more detail elsewhere in the labeling: Thromboembolic Risk [see Warnings and Precautions (5.1) ] Hypersensitivity Reactions [see Warnings and Precautions (5.3) ] Risks of Serious Adverse Reactions in Patients with Hereditary Fructose Intolerance due to Sorbitol Excipient [see Warnings and Precautions (5.4) ] In healthy volunteers, the most frequently reported adverse reactions in ≥5% of subjects treated with idarucizumab was headache. ( 6.1 ) In patients, the most frequently reported adverse reactions in ≥5% of patients treated with idarucizumab were constipation and nausea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Boehringer Ingelheim Pharmaceuticals, Inc. at 1-800-542-6257 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 clinical practice. In three healthy volunteer clinical trials, 224 subjects were treated with idarucizumab. In these trials, during the treatment period, the overall frequency of adverse events was similar between idarucizumab-treated subjects (55/224, 25%) and placebo-treated subjects (26/105, 25%). …
Source: FDA drug label, Boehringer Ingelheim Pharmaceuticals, Inc., effective January 23, 2024 (SPL set c7400f8a-dcf4-a6df-6d07-983081b1bf34), via openFDA; the full label on DailyMed
What do FAERS reports show?
1,428 reports list idarucizumab among the medicines taken, each a report of something that happened, not proof the medicine caused it; 894 are coded as a death and 515 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 23 reactions below, none is 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?
- Idarucizumab: 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