Ivosidenib side effects: what 2,057 FDA adverse event reports show
Drug class
Isocitrate Dehydrogenase 1 Inhibitor
Brand names
Tibsovo
Who reports
2,057 reports · 61% serious · 207 with death outcome · 49% female
Used for
TIBSOVO is an isocitrate dehydrogenase-1 (IDH1) inhibitor indicated for patients with a susceptible IDH1 mutation as detected by an FDA-approved test with: Newly Diagnosed Acute Myeloid Leukemia (AML) In combination with azacitidine or as monotherapy for the treatment of newly diagnosed AML in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy ( 1.1 ).
What it is
TIBSOVO (ivosidenib) is an inhibitor of isocitrate dehydrogenase 1 (IDH1) enzyme.
Boxed warning
DIFFERENTIATION SYNDROME IN AML AND MDS Patients treated with TIBSOVO have experienced symptoms of differentiation syndrome, which can be fatal. Symptoms may include fever, dyspnea, hypoxia, pulmonary infiltrates, pleural or pericardial effusions, rapid weight gain or peripheral edema, hypotension, and hepatic, renal, or multi-organ dysfunction.
Causality screen of the 29 strongest signals
What the badges mean
- Labeled — boxed warning The term (or its clinical synonym) appears in the FDA boxed warning: causality is regulator-recognised and considered serious.
- 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.
- 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. 11 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 |
|---|---|---|---|---|---|---|
| Electrocardiogram qt prolonged | 76 | 21.6 17.3–26.9ROR 22.4 · χ² 1,470 / p <1e-300 | 21.4 EB05 17.7 · IC025 +3.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 20.1 · 92% clinician | no trial data cached |
| Cytopenia | 19 | 16.2 10.4–25.4ROR 16.4 · χ² 256 / p 6e-58 | 15.7 EB05 10.2 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 15.8 | no trial data cached |
| Blood count abnormal | 21 | 13.9 9.1–21.3ROR 14.1 · χ² 239 / p 3e-54 | 13.3 EB05 8.7 · IC025 +2.7 3/3 methods agree | Lab value / disease marker | serious PRR 6.1 · 90% clinician | no trial data cached |
| Leukocytosis | 24 | 13.5 9.1–20.2ROR 13.7 · χ² 266 / p 4e-60 | 13.0 EB05 8.8 · IC025 +2.7 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 12.6 · 92% clinician | no trial data cached |
| Transfusion | 13 | 12.6 7.3–21.7ROR 12.7 · χ² 128 / p 7e-30 | 11.2 EB05 6.2 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 12.5 | no trial data cached |
| Hospice care | 12 | 12.4 7.1–21.9ROR 12.5 · χ² 115 / p 4e-27 | 10.8 EB05 5.9 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 12.8 | no trial data cached |
| Acute myeloid leukaemia | 18 | 11.8 7.4–18.7ROR 11.9 · χ² 167 / p 2e-38 | 10.8 EB05 6.7 · IC025 +2.4 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 11.2 | no trial data cached |
| Febrile neutropenia | 74 | 11.4 9.1–14.3ROR 11.8 · χ² 693 / p 4e-153 | 11.2 EB05 9.1 · IC025 +3.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 10.8 · 96% clinician | no trial data cached |
| Blood test abnormal | 14 | 10.2 6.0–17.2ROR 10.2 · χ² 107 / p 2e-25 | 8.7 EB05 5.1 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 9.5 | no trial data cached |
| Malignant neoplasm progression | 79 | 7.9 6.4–9.8ROR 8.2 · χ² 472 / p 6e-105 | 7.6 EB05 6.3 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 7.6 | no trial data cached |
| Platelet count increased | 10 | 7.8 4.2–14.5ROR 7.8 · χ² 53 / p 2e-13 | 6.1 EB05 3.4 · IC025 +1.5 3/3 methods agree | Lab value / disease marker | serious PRR 8.8 | no trial data cached |
| Off label use (used outside approved label) | 652 | 7.7 7.2–8.2ROR 10.8 · χ² 3,931 / p <1e-300 | 7.6 EB05 7.1 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious PRR 4.8 | no trial data cached |
| Disease progression | 88 | 7.6 6.2–9.3ROR 7.9 · χ² 501 / p 3e-111 | 7.4 EB05 6.2 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 4.2 · 91% clinician | no trial data cached |
| White blood cell count increased | 27 | 7.2 4.9–10.4ROR 7.2 · χ² 137 / p 6e-32 | 6.5 EB05 4.6 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.0 | no trial data cached |
| Red blood cell count decreased | 20 | 7.1 4.6–11.0ROR 7.2 · χ² 99 / p 1e-23 | 6.3 EB05 4.2 · IC025 +1.9 3/3 methods agree | Lab value / disease marker | serious PRR 7.1 | no trial data cached |
| Platelet count decreased | 74 | 7.1 5.7–8.9ROR 7.3 · χ² 382 / p 2e-85 | 6.8 EB05 5.6 · IC025 +2.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.2 | no trial data cached |
| Full blood count decreased | 14 | 7.1 4.2–11.9ROR 7.1 · χ² 67 / p 1e-16 | 5.9 EB05 3.7 · IC025 +1.6 3/3 methods agree | Lab value / disease marker | serious PRR 8.3 | no trial data cached |
| Ascites | 20 | 6.9 4.5–10.7ROR 7.0 · χ² 96 / p 6e-23 | 6.1 EB05 4.1 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.0 · 95% clinician | no trial data cached |
| Myelosuppression | 18 | 5.4 3.4–8.5ROR 5.4 · χ² 60 / p 4e-15 | 4.8 EB05 3.2 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 | no trial data cached |
| Pancytopenia (all blood cells low) | 29 | 5.3 3.7–7.6ROR 5.4 · χ² 97 / p 3e-23 | 4.9 EB05 3.6 · IC025 +1.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.1 | no trial data cached |
| Haemoglobin decreased | 53 | 5.3 4.0–6.9ROR 5.4 · χ² 179 / p 4e-41 | 5.0 EB05 4.0 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.0 | no trial data cached |
| Neoplasm progression | 18 | 5.2 3.3–8.3ROR 5.3 · χ² 57 / p 2e-14 | 4.7 EB05 3.1 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 1.9 | no trial data cached |
| Thrombocytopenia (low platelets) | 57 | 5.2 4.0–6.7ROR 5.3 · χ² 191 / p 1e-43 | 5.0 EB05 4.0 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.1 · 100% clinician | no trial data cached |
| Drug ineffective for unapproved indication | 28 | 5.1 3.5–7.4ROR 5.2 · χ² 89 / p 2e-21 | 4.7 EB05 3.4 · IC025 +1.6 3/3 methods agree | Reporting / coding artifact | serious PRR 3.1 | no trial data cached |
| Neutropenia (low neutrophils (infection-fighting cells)) | 65 | 4.9 3.9–6.2ROR 5.0 · χ² 199 / p 2e-45 | 4.7 EB05 3.8 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.8 · 95% clinician | no trial data cached |
| Product use issue | 78 | 4.3 3.4–5.3ROR 4.4 · χ² 193 / p 4e-44 | 4.2 EB05 3.4 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | serious PRR 8.1 | no trial data cached |
| Laboratory test abnormal | 11 | 3.8 2.1–6.9ROR 3.8 · χ² 20 / p 4e-6 | 3.4 EB05 2.0 · IC025 +0.7 3/3 methods agree | Reporting / coding artifact | serious PRR 3.9 | no trial data cached |
| Underdose | 24 | 3.3 2.2–5.0ROR 3.4 · χ² 37 / p 5e-10 | 3.2 EB05 2.3 · IC025 +1.0 3/3 methods agree | Reporting / coding artifact | serious PRR 11.1 | no trial data cached |
| Product dose omission | 18 | 2.8 1.7–4.4ROR 2.8 · χ² 19 / p 8e-6 | 2.6 EB05 1.8 · IC025 +0.6 | Reporting / coding artifact | serious PRR 3.6 | 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 |
|---|---|---|---|---|---|---|
| Off label use (used outside approved label) | 652 | 7.7 7.2–8.2ROR 10.8 · χ² 3,931 / p <1e-300 | 7.6 EB05 7.1 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious PRR 4.8 | no trial data cached |
| Disease progression | 88 | 7.6 6.2–9.3ROR 7.9 · χ² 501 / p 3e-111 | 7.4 EB05 6.2 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 4.2 · 91% clinician | no trial data cached |
| Malignant neoplasm progression | 79 | 7.9 6.4–9.8ROR 8.2 · χ² 472 / p 6e-105 | 7.6 EB05 6.3 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 7.6 | no trial data cached |
| Product use issue | 78 | 4.3 3.4–5.3ROR 4.4 · χ² 193 / p 4e-44 | 4.2 EB05 3.4 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | serious PRR 8.1 | no trial data cached |
| Electrocardiogram qt prolonged | 76 | 21.6 17.3–26.9ROR 22.4 · χ² 1,470 / p <1e-300 | 21.4 EB05 17.7 · IC025 +3.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 20.1 · 92% clinician | no trial data cached |
| Platelet count decreased | 74 | 7.1 5.7–8.9ROR 7.3 · χ² 382 / p 2e-85 | 6.8 EB05 5.6 · IC025 +2.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.2 | no trial data cached |
| Febrile neutropenia | 74 | 11.4 9.1–14.3ROR 11.8 · χ² 693 / p 4e-153 | 11.2 EB05 9.1 · IC025 +3.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 10.8 · 96% clinician | no trial data cached |
| Neutropenia (low neutrophils (infection-fighting cells)) | 65 | 4.9 3.9–6.2ROR 5.0 · χ² 199 / p 2e-45 | 4.7 EB05 3.8 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.8 · 95% clinician | no trial data cached |
| Thrombocytopenia (low platelets) | 57 | 5.2 4.0–6.7ROR 5.3 · χ² 191 / p 1e-43 | 5.0 EB05 4.0 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.1 · 100% clinician | no trial data cached |
| Haemoglobin decreased | 53 | 5.3 4.0–6.9ROR 5.4 · χ² 179 / p 4e-41 | 5.0 EB05 4.0 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.0 | no trial data cached |
| Pancytopenia (all blood cells low) | 29 | 5.3 3.7–7.6ROR 5.4 · χ² 97 / p 3e-23 | 4.9 EB05 3.6 · IC025 +1.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.1 | no trial data cached |
| Drug ineffective for unapproved indication | 28 | 5.1 3.5–7.4ROR 5.2 · χ² 89 / p 2e-21 | 4.7 EB05 3.4 · IC025 +1.6 3/3 methods agree | Reporting / coding artifact | serious PRR 3.1 | no trial data cached |
| White blood cell count increased | 27 | 7.2 4.9–10.4ROR 7.2 · χ² 137 / p 6e-32 | 6.5 EB05 4.6 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.0 | no trial data cached |
| Underdose | 24 | 3.3 2.2–5.0ROR 3.4 · χ² 37 / p 5e-10 | 3.2 EB05 2.3 · IC025 +1.0 3/3 methods agree | Reporting / coding artifact | serious PRR 11.1 | no trial data cached |
| Leukocytosis | 24 | 13.5 9.1–20.2ROR 13.7 · χ² 266 / p 4e-60 | 13.0 EB05 8.8 · IC025 +2.7 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 12.6 · 92% clinician | no trial data cached |
Unlabeled candidate signals
Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.
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 Ivosidenib?
In FDA FAERS, the most frequently co-reported reaction terms for Ivosidenib are electrocardiogram qt prolonged, platelet count decreased, febrile neutropenia, neutropenia, thrombocytopenia, haemoglobin decreased. 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 Ivosidenib have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: DIFFERENTIATION SYNDROME IN AML AND MDS Patients treated with TIBSOVO have experienced symptoms of differentiation syndrome, which can be fatal. Symptoms may include fever, dyspnea, hypoxia, pulmonary infiltrates, pleural or pericardial effusions, rapid weight gain or peripheral edema, hypotension, and hepatic, renal, or multi-organ dysfunction.
Do FAERS signals prove that Ivosidenib 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 65d254c0-67ad-42c4-b972-ad463b755b2d, effective 20251222; matched on
openfda.generic_name.exact:"IVOSIDENIB") - 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, 40 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.