What the label lists and what reports show
Anti-inhibitor coagulant complex side effects
Anti-inhibitor coagulant complex's FDA label: “The most frequently reported adverse reactions observed in >5% of subjects in the prophylaxis trial were anemia, diarrhea, hemarthrosis, hepatitis B surface antibody positive, nausea, and vomiting.” FAERS holds 1,102 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 (285 reports).
- No generic listed
- Boxed warning
Check it at the source: the anti-inhibitor coagulant complex FDA label on DailyMed (effective November 27, 2025); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe most frequently reported adverse reactions observed in >5% of subjects in the prophylaxis trial were anemia, diarrhea, hemarthrosis, hepatitis B surface antibody positive, nausea, and vomiting.
Table 2: Prophylaxis Study Adverse Reactions (ARs) in >5% of Subjects
| Adverse Reaction | Number of ARs | Number of Subjects | Percent of Subjects (N=36) |
|---|---|---|---|
| Anemia | 2 | 2 | 5.6 |
| Diarrhea | 2 | 2 | 5.6 |
| Hepatitis B Surface Antibody Positive | 4 | 4 | 11.1 |
| Hemarthrosis | 5 | 3 | 8.3 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe most frequently reported adverse reactions observed in >5% of subjects in the prophylaxis trial were anemia, diarrhea, hemarthrosis, hepatitis B surface antibody positive, nausea, and vomiting. The serious adverse reactions seen with FEIBA are hypersensitivity reactions and thromboembolic events, including stroke, pulmonary embolism and deep vein thrombosis. The most common adverse reactions observed in >5% of subjects were anemia, diarrhea, hemarthrosis, hepatitis B surface antibody positive, nausea, and vomiting. ( 6.1 ) The serious adverse drug reactions are hypersensitivity and thromboembolic events, including stroke, pulmonary embolism, and deep vein thrombosis. ( 5.1 , 5.2 , 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals U.S.A., Inc. at 1-877-TAKEDA-7 (1-877-825-3327) 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. …
Source: FDA drug label, Takeda Pharmaceuticals America, Inc., effective November 27, 2025 (SPL set 752604e5-4ea2-44f4-83ed-1569373f6412), via openFDA; the full label on DailyMed
What do FAERS reports show?
1,102 reports list anti-inhibitor coagulant complex among the medicines taken, each a report of something that happened, not proof the medicine caused it; 151 are coded as a death and 225 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 21 reactions below, 4 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?
- Anti-inhibitor coagulant complex: 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