Skip to Content

Ofev Side Effects

Generic Name: nintedanib

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

In 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. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to nintedanib: oral capsule

Along with its needed effects, nintedanib (the active ingredient contained in Ofev) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking nintedanib:

More Common

Less Common

  • Abdominal or stomach pain or swelling
  • black, tarry stools
  • blood in the urine
  • blurred vision
  • bruising or purple areas on the skin
  • chest pain or discomfort
  • coughing up blood
  • decreased alertness
  • dizziness
  • headache
  • irregular heartbeat
  • joint pain or swelling
  • nervousness
  • nosebleeds
  • pain or discomfort in the arms, jaw, back, or neck
  • pain in the chest, groin, or legs, especially calves of the legs
  • pounding in the ears
  • severe headaches of sudden onset
  • shortness of breath
  • slow or fast heartbeat
  • sudden loss of coordination
  • sudden onset of shortness of breath for no apparent reason
  • sudden onset of slurred speech
  • sudden vision changes
  • sweating

Some side effects of nintedanib may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More Common

Less Common

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]

References

1. "Product Information. Ofev (nintedanib)." Boehringer Ingelheim, Ridgefield, CT.

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Hide