Nintedanib
Pronunciation: nin-TED-a-nib.
- Generic name
- nintedanib
- Brand names
- Ofev (worldwide)
- Drug class
- Tyrosine kinase inhibitor (angiokinase inhibitor)
- Form
- Soft capsule
- Route
- Oral
- Legal status
- Prescription-only medicine
Availability and supply rules vary by country
Trade names by country: United States · United Kingdom · Canada · Australia · New Zealand
Australia: Ofev (5) · Full directory
What nintedanib is and how it works
Nintedanib is a prescription-only oral medicine that blocks several enzymes (tyrosine kinases) involved in scarring (fibrosis) of the lungs. It is used to slow the loss of lung function in certain long-term scarring lung diseases. (1)
Nintedanib does not reverse existing lung scarring, but clinical studies show it can slow the rate of decline in lung function over time. It is taken as a capsule twice daily with food. Regular blood tests to check liver function are required throughout treatment, and it carries important risks around the liver, digestive tract, bleeding, and blood clots that need prompt attention if symptoms develop.
Mechanism of action: how nintedanib works
Nintedanib is a small-molecule tyrosine kinase inhibitor that blocks receptors including PDGFR, FGFR, and VEGFR, inhibiting intracellular signalling cascades implicated in fibrotic tissue remodelling. (1)
What nintedanib is used for
Idiopathic pulmonary fibrosis (IPF)
Used to treat idiopathic pulmonary fibrosis, a chronic lung disease in which lung tissue becomes scarred over time for no known cause. (1)
Chronic fibrosing interstitial lung diseases with a progressive phenotype
Used to treat other long-term interstitial lung diseases where scarring is progressing despite standard management. (1)
Systemic sclerosis-associated interstitial lung disease (SSc-ILD)
Used to slow the rate of decline in lung function in adults with interstitial lung disease associated with systemic sclerosis (scleroderma). (1)
Before taking nintedanib
Do not take / not appropriate for
- Do not take nintedanib if you have had a hypersensitivity reaction to nintedanib, peanut, soya, or any other ingredient in the capsule. (all patients) (1)
Tell your clinician about
- Whether you are, or could become, pregnant, and your plans regarding pregnancy and contraception.
- Any history of liver problems or abnormal liver blood tests.
- Any history of stomach or bowel problems, including diverticular disease or recent abdominal surgery.
- Any history of bleeding problems, or if you take a blood thinner (anticoagulant).
- Any history of heart attack, stroke, or blood clots.
- Every other medicine and supplement you take, especially strong inhibitors or inducers of P-glycoprotein/CYP3A4 (such as ketoconazole or rifampicin) and any anticoagulant.
How to take nintedanib
- Take exactly as prescribed -- the standard dose is 150 mg twice daily, about 12 hours apart; your prescriber may start you on a lower dose (100 mg twice daily) if you have mild liver problems, or adjust your dose if you have side effects.
- Take with food, and swallow the capsule whole with liquid; do not chew or crush it.
- Do not change your dose, or stop or restart treatment, without your prescriber's involvement.
- You will need liver function blood tests before starting, regularly during the first 3 months, and periodically throughout treatment.
- If you can become pregnant, your prescriber will discuss effective contraception with you, to be used during treatment and for a period after your last dose.
Procedures and treatment changes
Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1) (2) (3) (4) (5) (6)
Missed dose
If you miss a dose, do not take a double dose. Take your next dose at the usual time and contact your prescriber or pharmacist if you are unsure how to proceed.
Overdose
Contact your prescriber, pharmacist, or a poison-control/emergency service if an overdose is suspected. There is no specific antidote; management focuses on treating symptoms and, where appropriate, standard supportive and decontamination measures under medical supervision. (1)
Side effects
Diarrhoea, nausea, and abdominal pain are commonly reported and are usually managed by your care team with hydration, antidiarrheal medicine, or a dose adjustment. Some effects, on the liver, digestive tract, bleeding, and blood clots, need prompt medical evaluation.
Diarrhoea
What to notice: The most commonly reported side effect; can be dose-limiting.
What to do: Tell your prescriber promptly -- early treatment with hydration and antidiarrheal medicine is recommended, and your prescriber will decide whether your dose needs to be adjusted or treatment paused. (1)
Nausea, vomiting, or decreased appetite
What to notice: Commonly reported digestive effects.
What to do: Tell your prescriber if severe, persistent, or affecting your ability to eat or drink. (1)
Headache or weight loss
What to notice: Commonly reported effects.
What to do: Tell your prescriber if bothersome or persistent. (1)
Raised blood pressure
What to notice: Commonly reported; usually identified through routine blood pressure checks.
What to do: Attend scheduled blood pressure checks; tell your prescriber about any home readings that are high. (1)
Possible liver injury
What to notice: Unusual tiredness, loss of appetite, yellowing of the skin or eyes, dark urine, pain in the upper right abdomen, or itching.
What to do: Contact your prescriber promptly for liver-function testing; rare cases of serious, including fatal, liver injury have been reported. (1) (4) (2)
Severe abdominal pain (possible gastrointestinal perforation)
What to notice: Severe, persistent abdominal pain, especially if you have a history of abdominal surgery, diverticular disease, or take corticosteroids or NSAIDs.
What to do: Seek emergency medical help immediately; gastrointestinal perforation is rare but serious. (1)
Unusual bleeding
What to notice: Unexpected bruising, blood in urine or stool, coughing up blood, or bleeding that does not stop.
What to do: Seek prompt medical attention; nintedanib can increase bleeding risk. (1)
Signs of a heart attack, stroke, or blood clot (arterial thromboembolic event)
What to notice: Chest pain or pressure, sudden weakness or numbness on one side of the body, sudden difficulty speaking, or sudden severe headache.
What to do: Seek emergency medical help immediately. (1)
Signs of PRES (posterior reversible encephalopathy syndrome)
What to notice: Headache with high blood pressure, visual disturbances, seizure, confusion, or lethargy.
What to do: Seek emergency medical help immediately; this is a rare but serious neurological condition that has been reported after starting nintedanib. (2)
Serious warnings
Liver injury — high caution
Symptoms: Usually detected via blood tests; may include unusual tiredness, loss of appetite, yellowing of skin/eyes, dark urine, or upper right abdominal pain.
Action: Requires liver-function blood tests before starting, regularly during the first 3 months, and periodically thereafter; a clinician will decide on dose adjustment or discontinuation based on results. (1)
Gastrointestinal perforation — emergency
Symptoms: Severe, persistent abdominal pain.
Action: Seek emergency medical help immediately; rare but serious, with higher risk after recent abdominal surgery, with diverticular disease, or with concomitant corticosteroids/NSAIDs. (1)
Bleeding — high caution
Symptoms: Unexpected bruising or bleeding.
Action: Tell your prescriber about any bleeding history or anticoagulant use before starting; report unusual bleeding promptly. (1)
Arterial thromboembolic events (including heart attack and stroke) — emergency
Symptoms: Chest pain, sudden weakness or numbness, difficulty speaking, or sudden severe headache.
Action: Seek emergency medical help immediately. (1)
Embryo-fetal toxicity — high caution
Symptoms: Not applicable -- a risk to a developing pregnancy rather than a symptom in the person taking the medicine.
Action: Nintedanib can cause fetal harm; anyone who can become pregnant should discuss effective contraception with their prescriber before, during, and for a period after treatment, and tell their prescriber immediately if pregnancy occurs or is suspected. (1)
Interactions
| Medicine or test | Effect | Action |
|---|---|---|
| Strong P-glycoprotein/CYP3A4 inhibitors (e.g. ketoconazole) | Can increase nintedanib blood levels, increasing the risk of side effects. | Tell your prescriber if you take one of these; you may need closer monitoring for tolerability. (1) |
| Strong P-glycoprotein/CYP3A4 inducers (e.g. rifampicin) | Can substantially reduce nintedanib blood levels, reducing effectiveness. | This combination should generally be avoided; tell your prescriber if you take one of these. (1) |
| Anticoagulants (blood thinners) | May add to bleeding risk. | Tell your prescriber if you take an anticoagulant; you may need closer monitoring. (1) |
Pregnancy, breastfeeding, kidney/liver function, age
People who can become pregnant
Nintedanib can cause fetal harm. Use effective contraception during treatment and for a period after your last dose, as advised by your prescriber, and tell your prescriber immediately if you become pregnant or suspect you might be. (1)
People with liver problems
A lower starting dose (100 mg twice daily) is used for mild liver impairment; nintedanib is not recommended for people with moderate or severe liver impairment. (1) (2)
Breastfeeding
Breastfeeding is not recommended during treatment because of the potential for serious side effects in a nursing infant. (1)
Monitoring
Before starting
- Baseline liver function tests.
- Pregnancy test for anyone who can become pregnant.
- Review of bleeding history, anticoagulant use, and cardiovascular risk factors.
During treatment
- Regular liver function tests, particularly during the first 3 months, then periodically.
- Blood pressure checks.
- Watch for signs of gastrointestinal perforation, bleeding, blood clots, or neurological symptoms suggesting PRES.
- Ongoing pregnancy prevention counselling for anyone who can become pregnant.
Storage
Store at 20C to 25C (68F to 77F); brief excursions to 15C-30C (59F-86F) are permitted. Protect from high humidity and excessive heat.
Professional information
Clinician-facing context only. Use the current local product information in full. UK/EU/Canada/Australia/New Zealand-specific details in this page are based on a web-search summary of regulator material, not an independently fetched primary document in every case -- verify against the current local source before relying on region-specific specifics.
United States
Indication: IPF, progressive fibrosing ILDs, SSc-ILD
Dose summary: 150 mg orally twice daily approximately 12 hours apart with food; 100 mg twice daily for mild (Child-Pugh A) hepatic impairment; dose reduction/interruption per label for adverse reactions (diarrhoea, liver enzyme elevation, other adverse reactions).
Renal context: Not extensively studied; use current local product information for renal impairment. (1)
Hepatic guidance
Obtain baseline liver function tests; monitor regularly during the first 3 months and periodically thereafter. Interrupt, reduce dose, or discontinue per label thresholds for ALT/AST/bilirubin elevations or clinical signs of liver injury.
Overdose note
No specific antidote. Manage per local poison-control and toxicology guidance; supportive care as clinically indicated. (1)
Frequently asked questions
Does nintedanib have a boxed warning?
No. The current US prescribing information for Ofev (nintedanib) does not include a boxed warning. Its most important risks -- effects on the liver, gastrointestinal perforation, bleeding, blood clots, and risk to a developing pregnancy -- are covered as Warnings and Precautions instead. (1)
Why do I need regular blood tests while taking nintedanib?
Nintedanib can affect the liver, so your prescriber will check your liver function with blood tests before you start, regularly during the first three months, and periodically afterward. (1)
What should I do if I get diarrhoea while taking nintedanib?
Tell your prescriber promptly. Diarrhoea is the most commonly reported side effect and is usually managed with hydration and antidiarrheal medicine; your prescriber will decide whether your dose needs to be adjusted or treatment temporarily paused. (1)
What is the mechanism of action of nintedanib?
Nintedanib is a small-molecule tyrosine kinase inhibitor that blocks receptors including PDGFR, FGFR, and VEGFR, inhibiting intracellular signalling cascades implicated in fibrotic tissue remodelling. (1)
References
- OFEV (nintedanib) capsules, for oral use -- full prescribing informationU.S. Food and Drug Administration / DailyMed (NIH), full prescribing information, Boehringer Ingelheim Pharmaceuticals, Inc. · United States · accessed 2026-07-29 · source 1
- Ofev 100 mg / 150 mg soft capsules -- Summary of Product Characteristicselectronic medicines compendium (emc), United Kingdom -- Boehringer Ingelheim · United Kingdom · accessed 2026-07-29 · source 2
- Ofev -- European Public Assessment Report (EPAR)European Medicines Agency (EMA) · European Union · accessed 2026-07-29 · source 3
- OFEV (nintedanib, as nintedanib esilate) Product MonographHealth Canada product monograph · Canada · accessed 2026-07-29 · source 4
- OFEV nintedanib (as esilate) 100 mg / 150 mg soft capsule -- ARTG registrationTherapeutic Goods Administration (TGA), Australia · Australia · accessed 2026-07-29 · source 5
- OFEV New Zealand Data SheetMedsafe (New Zealand regulator) · New Zealand · accessed 2026-07-29 · source 6
Brand names by country
Single-ingredient nintedanib names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.
Priority countries
United States
- Ofev (1)FDA approved currently labeled · 100 mg, 150 mg · Boehringer Ingelheim Pharmaceuticals, Inc.
United Kingdom
- Ofev (2)MHRA licensed emc smpc confirmed · 100 mg, 150 mg · Boehringer Ingelheim
Canada
- OFEV
Australia
- Ofev (5)TGA ARTG registered 2015-09-01 confirmed · 100 mg, 150 mg · Boehringer Ingelheim Pty Ltd
New Zealand
- Ofev (6)Medsafe approved confirmed · 100 mg, 150 mg · Boehringer Ingelheim (NZ) Limited
View brands in additional countries.
European Union
Ofev (3)