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What the label lists and what reports show

Odevixibat side effects

Odevixibat's FDA label: “Most common adverse reactions (>2%) are liver test abnormalities, diarrhea, abdominal pain, vomiting, and fat-soluble vitamin deficiency.” FAERS holds 350 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is diarrhoea (84 reports).

  • No generic listed

Check it at the source: the odevixibat FDA label on DailyMed (effective December 29, 2025, Ipsen Biopharmaceuticals, Inc.); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

Most common adverse reactions (>2%) are liver test abnormalities, diarrhea, abdominal pain, vomiting, and fat-soluble vitamin deficiency.

Table 3. Common Adverse Reactions Adverse reactions that occurred in ≥2% of BYLVAY-treated patients from a Clinical Study of BYLVAY in Patients with Progressive Familial Intrahepatic Cholestasis (Trial 1)

Adverse ReactionPlacebo N=20 n (%)BYLVAY 40 mcg/kg/day N=23 n (%)BYLVAY 120 mcg/kg/day N=19 n (%)
Diarrhea2 (10%)9 (39%)4 (21%)
Transaminases increased (ALT, AST)1 (5%)3 (13%)4 (21%)
Vomiting04 (17%)3 (16%)
Abdominal pain03 (13%)3 (16%)
Blood bilirubin increased2 (10%)3 (13%)2 (11%)
Fat-soluble vitamin deficiency (A, D, E)1 (5%)03 (16%)
Splenomegaly002 (11%)
Cholelithiasis001 (5%)
Dehydration001 (5%)
Fracture01 (4%)0

Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.

From the label: adverse reactions, continued

The following adverse reactions are discussed in greater detail in other sections of the label: Hepatotoxicity [ see Warnings and Precautions (5.1) ] Diarrhea [see Warnings and Precautions (5.2) ] Fat-Soluble Vitamin Deficiency [see Warnings and Precautions (5.3) ] PFIC: Most common adverse reactions (>2%) are liver test abnormalities, diarrhea, abdominal pain, vomiting, and fat-soluble vitamin deficiency. ( 6.1 ) ALGS: Most common adverse reactions (>5%) are diarrhea, abdominal pain, hematoma, and decreased weight. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Ipsen Biopharmaceuticals, Inc. at 1-855-463-5127, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. PFIC Clinical Studies Trial 1 is a randomized, double-blind, placebo-controlled, 24-week study of two dose levels of BYLVAY (40 mcg/kg and 120 mcg/kg) administered once daily [see Clinical Studies (14.1) ]. Sixty-two patients were randomized (1:1:1) to receive one of the following: BYLVAY 40 mcg/kg/day (n=23), BYLVAY 120 mcg/kg/day (n=19), or Placebo (n=20). …

Source: FDA drug label, Ipsen Biopharmaceuticals, Inc., effective December 29, 2025 (SPL set 0935cd31-3251-4a0a-ac23-25ca4be12be9), via openFDA; the full label on DailyMed

What do FAERS reports show?

350 reports list odevixibat among the medicines taken, each a report of something that happened, not proof the medicine caused it; 16 are coded as a death and 67 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 19 reactions below, 9 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

The 25 most reported reactions

  • Pruritus (a use or a product term, not a reaction)92
  • Diarrhoea (named in the label)84
  • Off Label Use (a use or a product term, not a reaction)64
  • Drug Ineffective (a use or a product term, not a reaction)37
  • Liver Transplant (named in the label)29
  • Product Dose Omission Issue (a use or a product term, not a reaction)25
  • Abdominal Pain Upper22
  • Abdominal Pain (named in the label)20
  • Hepatic Enzyme Increased20
  • Blood Bilirubin Increased (named in the label)19
  • Bile Acids Increased18
  • Alanine Aminotransferase Increased17
  • Vomiting (named in the label)16
  • Jaundice15
  • Nausea (named in the label)15
  • Aspartate Aminotransferase Increased13
  • Transaminases Increased (named in the label)11
  • Product Use Issue (a use or a product term, not a reaction)10
  • Weight Decreased (named in the label)10
  • Abdominal Discomfort9
  • Disease Progression (a use or a product term, not a reaction)7
  • Gamma-Glutamyltransferase Increased (named in the label)7
  • Hypovitaminosis7
  • Influenza7
  • Pyrexia7

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Odevixibat: the full record
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Side effects hub
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