Sonidegib side effects: what 1,494 FDA adverse event reports show

Sonidegib · Odomzo · 19 reaction terms · 782 drug–reaction co-reports · data 2026-09-14

Drug class

Hedgehog pathway inhibitor

FDA label, Indications wording

Brand names

Odomzo

openFDA label

Who reports

1,494 reports · 53% serious · 148 with death outcome · 38% female

openFDA FAERS counts, all years, deduplication not applied

Used for

ODOMZO (sonidegib) is indicated for the treatment of adult patients with locally advanced basal cell carcinoma (BCC) that has recurred following surgery or radiation therapy, or those who are not candidates for surgery or radiation therapy. ODOMZO is a.

FDA label, Indications and Usage

What it is

Sonidegib is a Hh pathway inhibitor.

FDA label, Description section

Boxed warning

EMBRYO-FETAL TOXICITY ODOMZO can cause embryo-fetal death or severe birth defects when administered to a pregnant woman. ODOMZO is embryotoxic, fetotoxic, and teratogenic in animals [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1) ] . Verify the pregnancy status of females of reproductive potential prior to initiating therapy.

FDA 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 16 strongest signals

Labeled adverse reaction 3Likely indication confounding 1Reporting / coding artifact 6Lab value / disease marker 1Not in label — unassessed 5

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.
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. 3 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
Ageusia (loss of taste)	64	36.0 28.3–45.8ROR 37.6 · χ² 2,140 / p <1e-300	35.6 EB05 28.8 · IC025 +4.4 3/3 methods agree	Not in label — unassessed	serious PRR 27.0 · 73% consumer	no trial data cached
Blood creatine phosphokinase increased	63	30.3 23.8–38.6ROR 31.6 · χ² 1,754 / p <1e-300	30.0 EB05 24.3 · IC025 +4.2 3/3 methods agree	Lab value / disease marker	serious PRR 32.8	no trial data cached
Taste disorder	33	23.1 16.5–32.4ROR 23.6 · χ² 677 / p 2e-149	22.8 EB05 17.0 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious PRR 24.6 · 73% consumer	no trial data cached
Basal cell carcinoma	24	21.6 14.5–32.1ROR 21.9 · χ² 451 / p 2e-100	21.2 EB05 15.0 · IC025 +3.2 3/3 methods agree	Likely indication confounding term in indications	serious PRR 24.3 · 92% clinician	no trial data cached
Therapy cessation	67	18.4 14.6–23.3ROR 19.2 · χ² 1,088 / p 6e-239	18.3 EB05 14.9 · IC025 +3.6 3/3 methods agree	Reporting / coding artifact	serious PRR 13.5 · 76% consumer	no trial data cached
Muscle spasms	195	14.9 13.1–17.0ROR 17.0 · χ² 2,539 / p <1e-300	14.9 EB05 13.2 · IC025 +3.6 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 15.9	no trial data cached
Squamous cell carcinoma	9	13.4 7.0–25.7ROR 13.5 · χ² 91 / p 6e-22	11.2 EB05 5.3 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 13.4	no trial data cached
Dysgeusia (altered taste)	50	9.4 7.2–12.3ROR 9.7 · χ² 368 / p 2e-82	9.0 EB05 7.0 · IC025 +2.6 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 21.3	no trial data cached
Alopecia (hair loss)	117	8.3 7.0–9.9ROR 9.0 · χ² 756 / p 9e-167	8.2 EB05 7.0 · IC025 +2.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 8.3	no trial data cached
Therapy interrupted	38	7.7 5.7–10.6ROR 7.9 · χ² 217 / p 2e-49	7.2 EB05 5.4 · IC025 +2.3 3/3 methods agree	Reporting / coding artifact	serious PRR 4.1	no trial data cached
Neoplasm	6	7.3 3.3–16.3ROR 7.3 · χ² 27 / p 1e-7	5.1 EB05 2.5 · IC025 +0.9 3/3 methods agree	Not in label — unassessed	serious PRR 8.7	no trial data cached
Therapy change	5	7.3 3.0–17.5ROR 7.3 · χ² 21 / p 2e-6	4.8 EB05 2.2 · IC025 +0.6 3/3 methods agree	Reporting / coding artifact	serious n=1	no trial data cached
Therapy partial responder	7	6.5 3.1–13.7ROR 6.6 · χ² 27 / p 8e-8	4.8 EB05 2.5 · IC025 +1.0 3/3 methods agree	Reporting / coding artifact	serious PRR 7.4	no trial data cached
Disease progression	54	6.4 4.9–8.4ROR 6.6 · χ² 243 / p 3e-55	6.1 EB05 4.9 · IC025 +2.2 3/3 methods agree	Reporting / coding artifact	serious PRR 8.1	no trial data cached
Madarosis	5	6.0 2.5–14.4ROR 6.0 · χ² 16 / p 3e-5	4.1 EB05 1.9 · IC025 +0.5	Not in label — unassessed	serious n=4	no trial data cached
Malignant neoplasm progression	33	4.5 3.2–6.4ROR 4.6 · χ² 88 / p 3e-21	4.3 EB05 3.2 · IC025 +1.5 3/3 methods agree	Reporting / coding artifact	serious PRR 4.9 · ♀ 69% (drug 38%)	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
Muscle spasms	195	14.9 13.1–17.0ROR 17.0 · χ² 2,539 / p <1e-300	14.9 EB05 13.2 · IC025 +3.6 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 15.9	no trial data cached
Alopecia (hair loss)	117	8.3 7.0–9.9ROR 9.0 · χ² 756 / p 9e-167	8.2 EB05 7.0 · IC025 +2.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 8.3	no trial data cached
Therapy cessation	67	18.4 14.6–23.3ROR 19.2 · χ² 1,088 / p 6e-239	18.3 EB05 14.9 · IC025 +3.6 3/3 methods agree	Reporting / coding artifact	serious PRR 13.5 · 76% consumer	no trial data cached
Ageusia (loss of taste)	64	36.0 28.3–45.8ROR 37.6 · χ² 2,140 / p <1e-300	35.6 EB05 28.8 · IC025 +4.4 3/3 methods agree	Not in label — unassessed	serious PRR 27.0 · 73% consumer	no trial data cached
Blood creatine phosphokinase increased	63	30.3 23.8–38.6ROR 31.6 · χ² 1,754 / p <1e-300	30.0 EB05 24.3 · IC025 +4.2 3/3 methods agree	Lab value / disease marker	serious PRR 32.8	no trial data cached
Disease progression	54	6.4 4.9–8.4ROR 6.6 · χ² 243 / p 3e-55	6.1 EB05 4.9 · IC025 +2.2 3/3 methods agree	Reporting / coding artifact	serious PRR 8.1	no trial data cached
Dysgeusia (altered taste)	50	9.4 7.2–12.3ROR 9.7 · χ² 368 / p 2e-82	9.0 EB05 7.0 · IC025 +2.6 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 21.3	no trial data cached
Therapy interrupted	38	7.7 5.7–10.6ROR 7.9 · χ² 217 / p 2e-49	7.2 EB05 5.4 · IC025 +2.3 3/3 methods agree	Reporting / coding artifact	serious PRR 4.1	no trial data cached
Malignant neoplasm progression	33	4.5 3.2–6.4ROR 4.6 · χ² 88 / p 3e-21	4.3 EB05 3.2 · IC025 +1.5 3/3 methods agree	Reporting / coding artifact	serious PRR 4.9 · ♀ 69% (drug 38%)	no trial data cached
Taste disorder	33	23.1 16.5–32.4ROR 23.6 · χ² 677 / p 2e-149	22.8 EB05 17.0 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious PRR 24.6 · 73% consumer	no trial data cached
Basal cell carcinoma	24	21.6 14.5–32.1ROR 21.9 · χ² 451 / p 2e-100	21.2 EB05 15.0 · IC025 +3.2 3/3 methods agree	Likely indication confounding term in indications	serious PRR 24.3 · 92% clinician	no trial data cached
Squamous cell carcinoma	9	13.4 7.0–25.7ROR 13.5 · χ² 91 / p 6e-22	11.2 EB05 5.3 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 13.4	no trial data cached
Therapy partial responder	7	6.5 3.1–13.7ROR 6.6 · χ² 27 / p 8e-8	4.8 EB05 2.5 · IC025 +1.0 3/3 methods agree	Reporting / coding artifact	serious PRR 7.4	no trial data cached
Neoplasm	6	7.3 3.3–16.3ROR 7.3 · χ² 27 / p 1e-7	5.1 EB05 2.5 · IC025 +0.9 3/3 methods agree	Not in label — unassessed	serious PRR 8.7	no trial data cached
Madarosis	5	6.0 2.5–14.4ROR 6.0 · χ² 16 / p 3e-5	4.1 EB05 1.9 · IC025 +0.5	Not in label — unassessed	serious n=4	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.

Ageusia — n=64, PRR 36.0
Taste disorder — n=33, PRR 23.1

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 Sonidegib?

In FDA FAERS, the most frequently co-reported reaction terms for Sonidegib are muscle spasms, alopecia, ageusia, blood creatine phosphokinase increased, dysgeusia, taste disorder. 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 Sonidegib have an FDA boxed warning?

Yes. The current FDA label carries a boxed warning: EMBRYO-FETAL TOXICITY ODOMZO can cause embryo-fetal death or severe birth defects when administered to a pregnant woman. ODOMZO is embryotoxic, fetotoxic, and teratogenic in animals [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1) ] . Verify the pregnancy status of females of reproductive potential prior to initiating therapy.

Do FAERS signals prove that Sonidegib 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 028312dc-d155-4fd5-8abd-6bb9f011d3cc, effective 20241231; matched on openfda.generic_name.exact:"SONIDEGIB")
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, 19 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.