Rydapt side effects: what 1,943 FDA adverse event reports show
Who reports
1,943 reports · 73% serious · 465 with death outcome · 47% female
Used for
RYDAPT is a kinase inhibitor indicated for the treatment of adult patients with: Newly diagnosed acute myeloid leukemia (AML) that is FLT3 mutation-positive as detected by an FDA-approved test, in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation. ( 1.1 ) Limitations of Use: RYDAPT is not indicated as a single-agent induction therapy for the treatment of patients with AML.
What it is
Midostaurin is a kinase inhibitor for oral use.
Boxed warning
None in the current label
Causality screen of the 28 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.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- 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.
- Outcome field, not a reaction Death is a report outcome, not a reaction term. It is dominated by the underlying illness; see the seriousness profile and the boxed warning instead.
- 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. 8 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 |
|---|---|---|---|---|---|---|
| Bone marrow failure | 76 | 40.2 32.3–50.2ROR 41.8 · χ² 2,861 / p <1e-300 | 39.7 EB05 32.8 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious PRR 31.9 · ♀ 13% (drug 47%) | no trial data cached |
| Leukaemia | 27 | 31.0 21.3–45.1ROR 31.4 · χ² 752 / p 8e-166 | 30.3 EB05 21.9 · IC025 +3.7 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 22.8 · 73% consumer | no trial data cached |
| Cytopenia | 28 | 25.3 17.5–36.6ROR 25.7 · χ² 629 / p 3e-139 | 24.9 EB05 18.1 · IC025 +3.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 20.0 | no trial data cached |
| Acute myeloid leukaemia | 30 | 20.8 14.6–29.7ROR 21.1 · χ² 546 / p 5e-121 | 20.5 EB05 15.0 · IC025 +3.4 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 16.0 | no trial data cached |
| Lymphadenopathy | 60 | 18.3 14.3–23.5ROR 18.9 · χ² 964 / p 6e-212 | 18.2 EB05 14.6 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 18.7 · ♀ 2% (drug 47%) | no trial data cached |
| Pancytopenia (all blood cells low) | 93 | 18.0 14.8–22.0ROR 18.9 · χ² 1,481 / p <1e-300 | 17.9 EB05 15.1 · IC025 +3.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 14.4 · ♀ 21% (drug 47%) | no trial data cached |
| Myocarditis | 17 | 16.2 10.1–26.1ROR 16.4 · χ² 228 / p 1e-51 | 15.6 EB05 9.8 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 12.9 | no trial data cached |
| Hyperbilirubinaemia | 15 | 15.7 9.5–26.1ROR 15.8 · χ² 192 / p 5e-44 | 14.9 EB05 8.9 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 12.7 | no trial data cached |
| Myelosuppression | 48 | 15.2 11.5–20.2ROR 15.6 · χ² 625 / p 3e-138 | 15.1 EB05 11.7 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 12.1 · ♀ 4% (drug 47%) | no trial data cached |
| Posterior reversible encephalopathy syndrome | 13 | 14.8 8.6–25.4ROR 14.8 · χ² 153 / p 2e-35 | 13.6 EB05 7.6 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 11.7 | no trial data cached |
| Ejection fraction decreased | 21 | 14.6 9.5–22.3ROR 14.7 · χ² 252 / p 5e-57 | 14.0 EB05 9.2 · IC025 +2.7 3/3 methods agree | Lab value / disease marker | serious PRR 12.1 · 90% clinician | no trial data cached |
| Febrile neutropenia | 78 | 12.7 10.2–15.8ROR 13.2 · χ² 833 / p 2e-183 | 12.6 EB05 10.3 · IC025 +3.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.1 · 92% clinician | no trial data cached |
| Hepatic cytolysis | 14 | 12.4 7.3–20.9ROR 12.5 · χ² 135 / p 2e-31 | 11.0 EB05 6.3 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 9.8 | no trial data cached |
| Bacteraemia | 11 | 10.1 5.6–18.2ROR 10.1 · χ² 81 / p 1e-19 | 8.2 EB05 4.5 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 8.1 | no trial data cached |
| Product use complaint | 12 | 8.4 4.8–14.7ROR 8.4 · χ² 71 / p 2e-17 | 6.8 EB05 4.0 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | serious n=2 | no trial data cached |
| Drug intolerance | 73 | 8.2 6.5–10.3ROR 8.5 · χ² 455 / p 2e-101 | 7.9 EB05 6.5 · IC025 +2.6 3/3 methods agree | Reporting / coding artifact | serious PRR 9.0 · ♀ 17% (drug 47%) | no trial data cached |
| Mucosal inflammation | 18 | 7.5 4.7–11.8ROR 7.5 · χ² 94 / p 1e-22 | 6.5 EB05 4.3 · IC025 +1.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.8 | no trial data cached |
| Agranulocytosis (severe loss of white cells) | 11 | 6.4 3.6–11.6ROR 6.5 · χ² 45 / p 9e-12 | 5.2 EB05 3.1 · IC025 +1.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.1 | no trial data cached |
| Electrocardiogram qt prolonged | 20 | 6.0 3.9–9.3ROR 6.1 · χ² 78 / p 4e-19 | 5.3 EB05 3.6 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.8 | no trial data cached |
| Septic shock | 24 | 6.0 4.0–8.9ROR 6.1 · χ² 95 / p 9e-23 | 5.4 EB05 3.8 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 | no trial data cached |
| Hepatotoxicity (liver damage) | 12 | 5.8 3.3–10.3ROR 5.9 · χ² 43 / p 2e-11 | 4.9 EB05 3.0 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 | no trial data cached |
| Platelet count decreased | 57 | 5.8 4.5–7.5ROR 5.9 · χ² 221 / p 2e-50 | 5.5 EB05 4.4 · IC025 +2.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.6 | no trial data cached |
| Pericardial effusion | 12 | 5.6 3.2–9.9ROR 5.7 · χ² 41 / p 7e-11 | 4.7 EB05 2.9 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.5 | no trial data cached |
| Malignant neoplasm progression | 53 | 5.6 4.3–7.3ROR 5.7 · χ² 197 / p 4e-45 | 5.4 EB05 4.3 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 4.5 | no trial data cached |
| Pneumonitis | 12 | 4.8 2.7–8.4ROR 4.8 · χ² 32 / p 6e-9 | 4.1 EB05 2.5 · IC025 +1.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.0 | no trial data cached |
| Death | 327 | 4.1 3.7–4.5ROR 4.7 · χ² 795 / p 3e-175 | 4.1 EB05 3.7 · IC025 +1.8 3/3 methods agree | Outcome field, not a reaction | serious PRR 3.3 | no trial data cached |
| Neoplasm progression | 11 | 3.4 1.9–6.1ROR 3.4 · χ² 16 / p 3e-5 | 3.0 EB05 1.8 · IC025 +0.6 | Not in label — unassessed | serious PRR 3.7 | no trial data cached |
| Therapy cessation | 15 | 3.2 1.9–5.2ROR 3.2 · χ² 20 / p 3e-6 | 2.9 EB05 1.9 · IC025 +0.7 | Reporting / coding artifact | serious PRR 3.7 | 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 |
|---|---|---|---|---|---|---|
| Death | 327 | 4.1 3.7–4.5ROR 4.7 · χ² 795 / p 3e-175 | 4.1 EB05 3.7 · IC025 +1.8 3/3 methods agree | Outcome field, not a reaction | serious PRR 3.3 | no trial data cached |
| Pancytopenia (all blood cells low) | 93 | 18.0 14.8–22.0ROR 18.9 · χ² 1,481 / p <1e-300 | 17.9 EB05 15.1 · IC025 +3.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 14.4 · ♀ 21% (drug 47%) | no trial data cached |
| Febrile neutropenia | 78 | 12.7 10.2–15.8ROR 13.2 · χ² 833 / p 2e-183 | 12.6 EB05 10.3 · IC025 +3.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.1 · 92% clinician | no trial data cached |
| Bone marrow failure | 76 | 40.2 32.3–50.2ROR 41.8 · χ² 2,861 / p <1e-300 | 39.7 EB05 32.8 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious PRR 31.9 · ♀ 13% (drug 47%) | no trial data cached |
| Drug intolerance | 73 | 8.2 6.5–10.3ROR 8.5 · χ² 455 / p 2e-101 | 7.9 EB05 6.5 · IC025 +2.6 3/3 methods agree | Reporting / coding artifact | serious PRR 9.0 · ♀ 17% (drug 47%) | no trial data cached |
| Lymphadenopathy | 60 | 18.3 14.3–23.5ROR 18.9 · χ² 964 / p 6e-212 | 18.2 EB05 14.6 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 18.7 · ♀ 2% (drug 47%) | no trial data cached |
| Platelet count decreased | 57 | 5.8 4.5–7.5ROR 5.9 · χ² 221 / p 2e-50 | 5.5 EB05 4.4 · IC025 +2.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.6 | no trial data cached |
| Malignant neoplasm progression | 53 | 5.6 4.3–7.3ROR 5.7 · χ² 197 / p 4e-45 | 5.4 EB05 4.3 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 4.5 | no trial data cached |
| Myelosuppression | 48 | 15.2 11.5–20.2ROR 15.6 · χ² 625 / p 3e-138 | 15.1 EB05 11.7 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 12.1 · ♀ 4% (drug 47%) | no trial data cached |
| Acute myeloid leukaemia | 30 | 20.8 14.6–29.7ROR 21.1 · χ² 546 / p 5e-121 | 20.5 EB05 15.0 · IC025 +3.4 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 16.0 | no trial data cached |
| Cytopenia | 28 | 25.3 17.5–36.6ROR 25.7 · χ² 629 / p 3e-139 | 24.9 EB05 18.1 · IC025 +3.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 20.0 | no trial data cached |
| Leukaemia | 27 | 31.0 21.3–45.1ROR 31.4 · χ² 752 / p 8e-166 | 30.3 EB05 21.9 · IC025 +3.7 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 22.8 · 73% consumer | no trial data cached |
| Septic shock | 24 | 6.0 4.0–8.9ROR 6.1 · χ² 95 / p 9e-23 | 5.4 EB05 3.8 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 | no trial data cached |
| Ejection fraction decreased | 21 | 14.6 9.5–22.3ROR 14.7 · χ² 252 / p 5e-57 | 14.0 EB05 9.2 · IC025 +2.7 3/3 methods agree | Lab value / disease marker | serious PRR 12.1 · 90% clinician | no trial data cached |
| Electrocardiogram qt prolonged | 20 | 6.0 3.9–9.3ROR 6.1 · χ² 78 / p 4e-19 | 5.3 EB05 3.6 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.8 | 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.
- Bone marrow failure — n=76, PRR 40.2
- Lymphadenopathy — n=60, PRR 18.3
- Myelosuppression — n=48, PRR 15.2
- Septic shock — n=24, PRR 6.0
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 Rydapt?
In FDA FAERS, the most frequently co-reported reaction terms for Rydapt are pancytopenia, febrile neutropenia, bone marrow failure, lymphadenopathy, platelet count decreased, myelosuppression. 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 Rydapt have an FDA boxed warning?
No. The FDA label retrieved for Rydapt has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Rydapt 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 11fa3fc9-6776-49a6-b1c1-653f627c3e58, effective 20260608; matched on
openfda.generic_name.exact:"RYDAPT") - 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, 36 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.