Note: This document contains side effect information about nintedanib. Some dosage forms listed on this page may not apply to the brand name Ofev.

Summary

Common side effects of Ofev include: abdominal pain, abdominal tenderness, abnormal hepatic function tests, diarrhea, gastrointestinal pain, increased gamma-glutamyl transferase, increased liver enzymes, increased serum alanine aminotransferase, increased serum aspartate aminotransferase, increased serum transaminases, lower abdominal pain, nausea, upper abdominal pain, vomiting, weight loss, hemorrhage, and decreased appetite. Continue reading for a comprehensive list of adverse effects.

Applies to nintedanib: oral capsules.

Side effects include:

Diarrhea, nausea, abdominal pain, vomiting, elevated concentrations of hepatic enzymes (e.g., ALT, AST, alkaline phosphatase), decreased appetite, headache, decreased weight, hypertension.

For Healthcare Professionals

Applies to nintedanib: oral capsule.

General

The most common side effects included diarrhea, nausea, abdominal pain, vomiting, liver enzyme elevation, decreased appetite, headache, weight decreased, hypertension, and peripheral neuropathy.^[Ref]

Gastrointestinal

Very common (10% or more): Diarrhea (62%), nausea (24%), abdominal pain (15%), vomiting (12%), constipation (12%), abdominal pain, mucositis (including stomatitis)

Uncommon (0.1% to 1%): Pancreatitis, GI perforation^[Ref]

Cardiovascular

Common (1% to 10%): Hypertension, venous thromboembolism, myocardial infarction, chest pain

Uncommon (0.1% to 1%): Hypertension^[Ref]

Hematologic

Very common (10% or more): Neutropenia (14%), hemoglobinemia (12%), bleeding events (10%)

Common (1% to 10%): Febrile neutropenia

Uncommon (0.1% to 1%): Thrombocytopenia^[Ref]

Hepatic

Very common (10% or more): Liver enzyme elevation (14%)

Common (1% to 10%): Hyperbilirubinemia, alanine aminotransferase (ALT) increased, aspartate aminotransferase (AST) increased, gamma glutamyl transferase (GGT) increased

Uncommon (0.1% to 1%): Drug induced liver injury, hyperbilirubinemia, blood alkaline phosphatase (ALKP) increased^[Ref]

Dermatologic

Very common (10% or more): Alopecia (18%), rash^[Ref]

Endocrine

Common (1% to 10%): Hypothyroidism^[Ref]

Metabolic

Very common (10% or more): Decreased appetite (11%), weight loss (10%)

Common (1% to 10%): Dehydration

Frequency not reported: Electrolyte imbalance^[Ref]

Nervous system

Very common (10% or more): Peripheral neuropathy (19%)

Common (1% to 10%): Headache^[Ref]

Oncologic

Frequency not reported: Lung neoplasm malignant^[Ref]

Other

Very common (10% or more): Fatigue (27%), pyrexia (15%)

Frequency not reported: Embryofetal toxicity^[Ref]

Respiratory

Very common (10% or more): Nasopharyngitis (56%), bronchitis (11%), dyspnea (17%), cough (17%), idiopathic pulmonary fibrosis (10%)

Common (1% to 10%): Upper respiratory tract infection, pneumonia^[Ref]

Immunologic

Common (1% to 10%): Abscesses, sepsis^[Ref]

Musculoskeletal

Common (1% to 10%): Back pain, arthralgia^[Ref]