Momelotinib side effects: what 1,339 FDA adverse event reports show

Momelotinib · Ojjaara · 17 reaction terms · 495 drug–reaction co-reports · data 2026-09-14

Drug class

Kinase inhibitor

FDA label, Indications wording

Brand names

Ojjaara

openFDA label

Who reports

1,339 reports · 66% serious · 208 with death outcome · 48% female

openFDA FAERS counts, all years, deduplication not applied

Used for

OJJAARA is indicated for the treatment of intermediate or high‑risk myelofibrosis (MF), including primary MF or secondary MF [post‑polycythemia vera (PV) and post‑essential thrombocythemia (ET)], in adults with anemia. OJJAARA is a kinase inhibitor ind.

FDA label, Indications and Usage

What it is

OJJAARA contains momelotinib dihydrochloride monohydrate, which is a kinase inhibitor with the chemical name N‑(Cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide dihydrochloride monohydrate.

FDA label, Description section

Boxed warning

None in the current label

How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation. Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)? That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.

Causality screen of the 17 strongest signals

Labeled adverse reaction 2Labeled (related wording) 3Reporting / coding artifact 1Lab value / disease marker 4Not in label — unassessed 7

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. 0 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Splenomegaly	49	65.8 50.0–86.7ROR 68.3 · χ² 3,052 / p <1e-300	64.0 EB05 50.3 · IC025 +4.8 3/3 methods agree	Not in label — unassessed	serious PRR 43.2	no trial data cached
Platelet count increased	24	28.8 19.4–42.9ROR 29.3 · χ² 616 / p 3e-136	28.2 EB05 19.9 · IC025 +3.5 3/3 methods agree	Lab value / disease marker	serious PRR 15.1	no trial data cached
Leukaemia	13	21.6 12.6–37.1ROR 21.8 · χ² 235 / p 2e-53	20.8 EB05 12.6 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 18.9	no trial data cached
Acute myeloid leukaemia	18	18.1 11.4–28.7ROR 18.4 · χ² 274 / p 7e-62	17.6 EB05 11.5 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 15.8	no trial data cached
Thrombocytopenia (low platelets)	109	15.3 12.8–18.3ROR 16.6 · χ² 1,451 / p <1e-300	15.2 EB05 13.0 · IC025 +3.5 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 13.8 · 97% clinician	no trial data cached
Leukocytosis	11	9.5 5.3–17.2ROR 9.6 · χ² 76 / p 2e-18	7.7 EB05 4.3 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 7.0	no trial data cached
White blood cell count increased	22	9.0 5.9–13.6ROR 9.1 · χ² 148 / p 3e-34	8.0 EB05 5.4 · IC025 +2.2 3/3 methods agree	Lab value / disease marker	serious PRR 6.4	no trial data cached
Neuropathy peripheral (nerve damage in hands/feet)	54	8.9 6.9–11.6ROR 9.3 · χ² 375 / p 8e-84	8.6 EB05 6.7 · IC025 +2.6 3/3 methods agree	Labeled (related wording) related wording	serious PRR 8.3	no trial data cached
Platelet count decreased	55	8.1 6.2–10.5ROR 8.4 · χ² 336 / p 2e-75	7.7 EB05 6.1 · IC025 +2.5 3/3 methods agree	Labeled (related wording) related wording	serious PRR 4.8	no trial data cached
Haemoglobin decreased	53	8.1 6.2–10.5ROR 8.4 · χ² 323 / p 2e-72	7.7 EB05 6.0 · IC025 +2.5 3/3 methods agree	Labeled (related wording) related wording	serious PRR 4.7	no trial data cached
Cytopenia	6	7.9 3.5–17.5ROR 7.9 · χ² 29 / p 3e-8	5.4 EB05 2.6 · IC025 +0.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 7.1	no trial data cached
Subarachnoid haemorrhage	5	7.7 3.2–18.4ROR 7.7 · χ² 23 / p 9e-7	5.0 EB05 2.3 · IC025 +0.7 3/3 methods agree	Not in label — unassessed	serious PRR 6.7	no trial data cached
Transfusion	5	7.4 3.1–17.9ROR 7.5 · χ² 22 / p 1e-6	4.9 EB05 2.2 · IC025 +0.7 3/3 methods agree	Not in label — unassessed	serious PRR 2.7	no trial data cached
Blood lactate dehydrogenase increased	7	6.9 3.3–14.4ROR 6.9 · χ² 30 / p 3e-8	5.0 EB05 2.6 · IC025 +1.0 3/3 methods agree	Lab value / disease marker	serious PRR 6.4	no trial data cached
Subdural haematoma	6	6.5 2.9–14.5ROR 6.6 · χ² 23 / p 8e-7	4.6 EB05 2.3 · IC025 +0.8 3/3 methods agree	Not in label — unassessed	serious PRR 5.7	no trial data cached
Full blood count decreased	7	5.4 2.6–11.4ROR 5.5 · χ² 21 / p 2e-6	4.2 EB05 2.2 · IC025 +0.8 3/3 methods agree	Lab value / disease marker	serious PRR 6.8	no trial data cached
Hospitalisation	51	5.2 4.0–6.9ROR 5.4 · χ² 172 / p 1e-39	5.0 EB05 4.0 · IC025 +1.9 3/3 methods agree	Reporting / coding artifact	serious PRR 3.1	no trial data cached

Trial evidence (ClinicalTrials.gov)

Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).

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
Thrombocytopenia (low platelets)	109	15.3 12.8–18.3ROR 16.6 · χ² 1,451 / p <1e-300	15.2 EB05 13.0 · IC025 +3.5 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 13.8 · 97% clinician	no trial data cached
Platelet count decreased	55	8.1 6.2–10.5ROR 8.4 · χ² 336 / p 2e-75	7.7 EB05 6.1 · IC025 +2.5 3/3 methods agree	Labeled (related wording) related wording	serious PRR 4.8	no trial data cached
Neuropathy peripheral (nerve damage in hands/feet)	54	8.9 6.9–11.6ROR 9.3 · χ² 375 / p 8e-84	8.6 EB05 6.7 · IC025 +2.6 3/3 methods agree	Labeled (related wording) related wording	serious PRR 8.3	no trial data cached
Haemoglobin decreased	53	8.1 6.2–10.5ROR 8.4 · χ² 323 / p 2e-72	7.7 EB05 6.0 · IC025 +2.5 3/3 methods agree	Labeled (related wording) related wording	serious PRR 4.7	no trial data cached
Hospitalisation	51	5.2 4.0–6.9ROR 5.4 · χ² 172 / p 1e-39	5.0 EB05 4.0 · IC025 +1.9 3/3 methods agree	Reporting / coding artifact	serious PRR 3.1	no trial data cached
Splenomegaly	49	65.8 50.0–86.7ROR 68.3 · χ² 3,052 / p <1e-300	64.0 EB05 50.3 · IC025 +4.8 3/3 methods agree	Not in label — unassessed	serious PRR 43.2	no trial data cached
Platelet count increased	24	28.8 19.4–42.9ROR 29.3 · χ² 616 / p 3e-136	28.2 EB05 19.9 · IC025 +3.5 3/3 methods agree	Lab value / disease marker	serious PRR 15.1	no trial data cached
White blood cell count increased	22	9.0 5.9–13.6ROR 9.1 · χ² 148 / p 3e-34	8.0 EB05 5.4 · IC025 +2.2 3/3 methods agree	Lab value / disease marker	serious PRR 6.4	no trial data cached
Acute myeloid leukaemia	18	18.1 11.4–28.7ROR 18.4 · χ² 274 / p 7e-62	17.6 EB05 11.5 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 15.8	no trial data cached
Leukaemia	13	21.6 12.6–37.1ROR 21.8 · χ² 235 / p 2e-53	20.8 EB05 12.6 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 18.9	no trial data cached
Leukocytosis	11	9.5 5.3–17.2ROR 9.6 · χ² 76 / p 2e-18	7.7 EB05 4.3 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 7.0	no trial data cached
Full blood count decreased	7	5.4 2.6–11.4ROR 5.5 · χ² 21 / p 2e-6	4.2 EB05 2.2 · IC025 +0.8 3/3 methods agree	Lab value / disease marker	serious PRR 6.8	no trial data cached
Blood lactate dehydrogenase increased	7	6.9 3.3–14.4ROR 6.9 · χ² 30 / p 3e-8	5.0 EB05 2.6 · IC025 +1.0 3/3 methods agree	Lab value / disease marker	serious PRR 6.4	no trial data cached
Subdural haematoma	6	6.5 2.9–14.5ROR 6.6 · χ² 23 / p 8e-7	4.6 EB05 2.3 · IC025 +0.8 3/3 methods agree	Not in label — unassessed	serious PRR 5.7	no trial data cached
Cytopenia	6	7.9 3.5–17.5ROR 7.9 · χ² 29 / p 3e-8	5.4 EB05 2.6 · IC025 +0.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 7.1	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.

Splenomegaly — n=49, PRR 65.8

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 Momelotinib?

In FDA FAERS, the most frequently co-reported reaction terms for Momelotinib are thrombocytopenia, platelet count decreased, neuropathy peripheral, haemoglobin decreased, splenomegaly, platelet count increased. 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 Momelotinib have an FDA boxed warning?

No. The FDA label retrieved for Momelotinib has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Momelotinib 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 4a672fd1-eb7b-4aa9-9b23-845e4b5dc400, effective 20260720; matched on openfda.generic_name.exact:"MOMELOTINIB")
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, field patient.drug.openfda.generic_name.exact, 17 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.