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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
  • 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.[Ref]

Gastrointestinal

Very common (10% or more): Diarrhea (up to 62%), nausea (24%), abdominal pain (15%), vomiting (12%)
Uncommon (0.1% to 1%): Gastrointestinal perforation[Ref]

Cardiovascular

Common (1% to 10%): Hypertension, venous thromboembolism, myocardial infarction[Ref]

Hematologic

Very common (10% or more): Bleeding events (10%)
Common (1% to 10%): Febrile neutropenia
Frequency not reported: Neutropenia[Ref]

Hepatic

Very common (10% or more): Liver enzyme elevation (up to 43%)
Common (1% to 10%): Hyperbilirubinemia[Ref]

Dermatologic

Frequency not reported: Mucositis (including stomatitis), rash[Ref]

Endocrine

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

Metabolic

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

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

Respiratory

Common (1% to 10%): Bronchitis
Frequency not reported: Pneumonia[Ref]

References

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

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

Some side effects of Ofev may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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