Caplacizumab side effects: what 1,707 FDA adverse event reports show
Drug class
Von willebrand factor (vwf)-directed antibody fragment
Brand names
Cablivi
Who reports
1,707 reports · 42% serious · 105 with death outcome · 69% female
Used for
CABLIVI is indicated for the treatment of adult and pediatric patients 12 years of age and older with acquired thrombotic thrombocytopenic purpura (aTTP), in combination with plasma exchange and immunosuppressive therapy. CABLIVI is a von Willebrand fa.
What it is
Caplacizumab-yhdp is a von Willebrand factor (vWF)-directed antibody fragment that consists of two identical humanized building blocks, linked by a three-alanine linker. Caplacizumab-yhdp is produced in Escherichia coli by recombinant DNA technology and has an approximate molecular weight of 28 kDa.
Boxed warning
None in the current label
Causality screen of the 26 strongest signals
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 25 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Gingival bleeding | 47 | 42.3 31.9–56.1ROR 43.5 · χ² 1,849 / p <1e-300 | 41.5 EB05 32.5 · IC025 +4.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 25.5 | no trial data cached |
| Platelet count increased | 41 | 38.6 28.5–52.3ROR 39.5 · χ² 1,461 / p <1e-300 | 37.9 EB05 29.1 · IC025 +4.2 3/3 methods agree | Lab value / disease marker | serious PRR 20.2 | no trial data cached |
| Product use in unapproved indication | 573 | 28.8 27.0–30.8ROR 42.9 · χ² 15,519 / p <1e-300 | 28.8 EB05 26.8 · IC025 +4.7 3/3 methods agree | Reporting / coding artifact | serious PRR 16.6 | no trial data cached |
| Epistaxis (nosebleed) | 129 | 21.2 17.9–25.0ROR 22.8 · χ² 2,461 / p <1e-300 | 21.1 EB05 18.2 · IC025 +4.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 15.2 | no trial data cached |
| Blood lactate dehydrogenase increased | 25 | 19.3 13.0–28.4ROR 19.5 · χ² 414 / p 2e-92 | 18.9 EB05 13.4 · IC025 +3.2 3/3 methods agree | Lab value / disease marker | serious PRR 17.8 | no trial data cached |
| Platelet count decreased | 129 | 14.9 12.6–17.6ROR 16.0 · χ² 1,662 / p <1e-300 | 14.8 EB05 12.8 · IC025 +3.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 16.1 | no trial data cached |
| Incorrect route of product administration | 16 | 11.7 7.2–19.0ROR 11.8 · χ² 146 / p 7e-34 | 10.5 EB05 6.3 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious PRR 7.9 | no trial data cached |
| Contusion | 86 | 11.0 8.9–13.5ROR 11.5 · χ² 773 / p 2e-170 | 10.8 EB05 8.9 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 7.8 | no trial data cached |
| Ischaemic stroke | 15 | 10.3 6.2–17.1ROR 10.4 · χ² 117 / p 2e-27 | 8.9 EB05 5.4 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 14.0 | no trial data cached |
| Injection site bruising | 64 | 10.0 7.8–12.7ROR 10.3 · χ² 509 / p 6e-113 | 9.7 EB05 7.7 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 12.8 | no trial data cached |
| Haematocrit decreased | 16 | 9.8 6.0–16.0ROR 9.9 · χ² 118 / p 7e-28 | 8.5 EB05 5.3 · IC025 +2.1 3/3 methods agree | Lab value / disease marker | serious PRR 6.6 | no trial data cached |
| Injection site rash | 17 | 6.9 4.3–11.0ROR 6.9 · χ² 80 / p 2e-19 | 5.9 EB05 3.9 · IC025 +1.7 3/3 methods agree | Labeled (related wording) related wording | serious n=1 | no trial data cached |
| Laboratory test abnormal | 14 | 5.8 3.5–9.8ROR 5.9 · χ² 51 / p 4e-13 | 5.0 EB05 3.1 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | serious PRR 4.0 | no trial data cached |
| Disease recurrence | 22 | 5.7 3.7–8.6ROR 5.7 · χ² 80 / p 2e-19 | 5.1 EB05 3.5 · IC025 +1.6 3/3 methods agree | Reporting / coding artifact | serious PRR 11.7 | no trial data cached |
| Drug effective for unapproved indication | 13 | 5.5 3.2–9.4ROR 5.5 · χ² 43 / p 3e-11 | 4.6 EB05 2.9 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious n=6 | no trial data cached |
| Haemorrhage | 45 | 5.3 4.0–7.0ROR 5.4 · χ² 153 / p 2e-35 | 5.0 EB05 3.9 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.2 | no trial data cached |
| Gastrointestinal haemorrhage | 34 | 5.0 3.6–6.9ROR 5.0 · χ² 104 / p 1e-24 | 4.7 EB05 3.5 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.8 | no trial data cached |
| Vaginal haemorrhage | 17 | 4.9 3.1–7.9ROR 4.9 · χ² 49 / p 1e-12 | 4.4 EB05 2.9 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.1 | no trial data cached |
| Cerebral haemorrhage | 14 | 4.8 2.9–8.1ROR 4.8 · χ² 39 / p 3e-10 | 4.2 EB05 2.7 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 6.5 | no trial data cached |
| Injection site haemorrhage | 31 | 4.8 3.4–6.8ROR 4.9 · χ² 90 / p 1e-21 | 4.5 EB05 3.3 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.7 | no trial data cached |
| Haematoma | 10 | 4.7 2.5–8.8ROR 4.7 · χ² 26 / p 2e-7 | 4.0 EB05 2.3 · IC025 +0.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.3 | no trial data cached |
| Mood altered | 10 | 4.5 2.4–8.4ROR 4.5 · χ² 24 / p 5e-7 | 3.8 EB05 2.3 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 1.1 | no trial data cached |
| Injection site pruritus | 23 | 4.2 2.8–6.4ROR 4.3 · χ² 54 / p 1e-13 | 3.9 EB05 2.8 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.6 · ♀ 90% (drug 69%) | no trial data cached |
| Hospitalisation | 50 | 4.0 3.1–5.3ROR 4.1 · χ² 112 / p 2e-26 | 3.9 EB05 3.1 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | serious PRR 5.6 · 70% consumer | no trial data cached |
| Injection site pain (pain where injected) | 77 | 3.1 2.5–3.9ROR 3.2 · χ² 110 / p 5e-26 | 3.1 EB05 2.5 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.9 | no trial data cached |
| Injection site erythema (redness where injected) | 31 | 3.1 2.2–4.4ROR 3.1 · χ² 42 / p 5e-11 | 3.0 EB05 2.2 · IC025 +1.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.0 · ♀ 93% (drug 69%) | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Product use in unapproved indication | 573 | 28.8 27.0–30.8ROR 42.9 · χ² 15,519 / p <1e-300 | 28.8 EB05 26.8 · IC025 +4.7 3/3 methods agree | Reporting / coding artifact | serious PRR 16.6 | no trial data cached |
| Platelet count decreased | 129 | 14.9 12.6–17.6ROR 16.0 · χ² 1,662 / p <1e-300 | 14.8 EB05 12.8 · IC025 +3.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 16.1 | no trial data cached |
| Epistaxis (nosebleed) | 129 | 21.2 17.9–25.0ROR 22.8 · χ² 2,461 / p <1e-300 | 21.1 EB05 18.2 · IC025 +4.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 15.2 | no trial data cached |
| Contusion | 86 | 11.0 8.9–13.5ROR 11.5 · χ² 773 / p 2e-170 | 10.8 EB05 8.9 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 7.8 | no trial data cached |
| Injection site pain (pain where injected) | 77 | 3.1 2.5–3.9ROR 3.2 · χ² 110 / p 5e-26 | 3.1 EB05 2.5 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.9 | no trial data cached |
| Injection site bruising | 64 | 10.0 7.8–12.7ROR 10.3 · χ² 509 / p 6e-113 | 9.7 EB05 7.7 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 12.8 | no trial data cached |
| Hospitalisation | 50 | 4.0 3.1–5.3ROR 4.1 · χ² 112 / p 2e-26 | 3.9 EB05 3.1 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | serious PRR 5.6 · 70% consumer | no trial data cached |
| Gingival bleeding | 47 | 42.3 31.9–56.1ROR 43.5 · χ² 1,849 / p <1e-300 | 41.5 EB05 32.5 · IC025 +4.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 25.5 | no trial data cached |
| Haemorrhage | 45 | 5.3 4.0–7.0ROR 5.4 · χ² 153 / p 2e-35 | 5.0 EB05 3.9 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.2 | no trial data cached |
| Platelet count increased | 41 | 38.6 28.5–52.3ROR 39.5 · χ² 1,461 / p <1e-300 | 37.9 EB05 29.1 · IC025 +4.2 3/3 methods agree | Lab value / disease marker | serious PRR 20.2 | no trial data cached |
| Gastrointestinal haemorrhage | 34 | 5.0 3.6–6.9ROR 5.0 · χ² 104 / p 1e-24 | 4.7 EB05 3.5 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.8 | no trial data cached |
| Injection site erythema (redness where injected) | 31 | 3.1 2.2–4.4ROR 3.1 · χ² 42 / p 5e-11 | 3.0 EB05 2.2 · IC025 +1.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.0 · ♀ 93% (drug 69%) | no trial data cached |
| Injection site haemorrhage | 31 | 4.8 3.4–6.8ROR 4.9 · χ² 90 / p 1e-21 | 4.5 EB05 3.3 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.7 | no trial data cached |
| Blood lactate dehydrogenase increased | 25 | 19.3 13.0–28.4ROR 19.5 · χ² 414 / p 2e-92 | 18.9 EB05 13.4 · IC025 +3.2 3/3 methods agree | Lab value / disease marker | serious PRR 17.8 | no trial data cached |
| Injection site pruritus | 23 | 4.2 2.8–6.4ROR 4.3 · χ² 54 / p 1e-13 | 3.9 EB05 2.8 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.6 · ♀ 90% (drug 69%) | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Contusion — n=86, PRR 11.0
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Caplacizumab?
In FDA FAERS, the most frequently co-reported reaction terms for Caplacizumab are platelet count decreased, epistaxis, contusion, injection site pain, injection site bruising, gingival bleeding. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Caplacizumab have an FDA boxed warning?
No. The FDA label retrieved for Caplacizumab has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Caplacizumab causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 2348f06e-8004-4040-832e-e9e86a39f905, effective 20260424; matched on
openfda.generic_name.exact:"CAPLACIZUMAB") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 51 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.