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Ofev

Generic Name: nintedanib (nin TED a nib)
Brand Names: Ofev
Ofev (nintedanib) is used to treat a lung disease called idiopathic pulmonary fibrosis, and systemic sclerosis-associated interstitial lung disease (SSc-ILD). Includes Ofev side effects, interactions and indications.
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Drug Information:
Ofev (nintedanib) is used in people with diseases that cause scar tissue to form deep within the lungs. The scar tissue thickens and becomes stiff over time, which can make it harder for your lungs to work. Decreased lung function can make it hard for you to breathe. Other medical problems can occur when your brain, heart, and other organs do not get enough oxygen. Ofev is used to treat idiopathic pulmonary fibrosis (IPF). This medicine is also used to slow the decline in lung function in people with a disorder called systemic sclerosis-associated interstitial lung disease (sometimes called scleroderma-associated ILD). Learn more

Ofev Side Effects

Ofev Side Effects

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

  • Diarrhea
  • nausea
  • severe stomach pain
  • vomiting

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

  • Decreased appetite
  • weight loss

Less common

  • Constipation
  • depression
  • dry skin and hair
  • feeling cold
  • hair loss
  • hoarseness or husky voice
  • muscle cramps and stiffness
  • slow heartbeat
  • unusual tiredness or weakness
  • weight gain

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.

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

Cardiovascular

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

Uncommon (0.1% to 1%): Hypertension

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

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

Dermatologic

Very common (10% or more): Alopecia (18%), rash

Endocrine

Common (1% to 10%): Hypothyroidism

Metabolic

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

Common (1% to 10%): Dehydration

Frequency not reported: Electrolyte imbalance

Nervous system

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

Common (1% to 10%): Headache

Oncologic

Frequency not reported: Lung neoplasm malignant

Other

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

Frequency not reported: Embryofetal toxicity

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

Immunologic

Common (1% to 10%): Abscesses, sepsis

Musculoskeletal

Common (1% to 10%): Back pain, arthralgia

Editorial References and Review

Medically reviewed by BestRx Medical Team Last updated on 1/1/2020.

Source: Drugs.com Ofev