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Generic Name
Nintedanib
Brand Names
Nintedanib esylate, Ofev
FDA approval date: October 15, 2014
Classification: Kinase Inhibitor
Form: Capsule
What is Nintedanib esylate (Nintedanib)?
Nintedanib capsules are kinase inhibitor indicated in adults for: Treatment of idiopathic pulmonary fibrosis .
Approved To Treat
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Brand Information
Nintedanib esylate (Nintedanib esylate)
1DOSAGE FORMS & STRENGTHS
Capsules:
2CONTRAINDICATIONS
None.
3ADVERSE REACTIONS
The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling:
3.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Table 1 Adverse Reactions Occurring in ≥5% of Nintedanib capsules-treated Patients with Idiopathic Pulmonary Fibrosis and More Commonly Than Placebo in Study 1, Study 2, and Study 3
a Includes abdominal pain, abdominal pain upper, abdominal pain lower, gastrointestinal pain and abdominal tenderness.
b Includes gamma-glutamyltransferase increased, hepatic enzyme increased, alanine aminotransferase increased, aspartate aminotransferase increased, hepatic function abnormal, liver function test abnormal, transaminase increased, blood alkaline phosphatase-increased, alanine aminotransferase abnormal, aspartate aminotransferase abnormal, and gamma-glutamyltransferase abnormal.
c Includes hypertension, blood pressure increased, hypertensive crisis, and hypertensive cardiomyopathy.
b Includes gamma-glutamyltransferase increased, hepatic enzyme increased, alanine aminotransferase increased, aspartate aminotransferase increased, hepatic function abnormal, liver function test abnormal, transaminase increased, blood alkaline phosphatase-increased, alanine aminotransferase abnormal, aspartate aminotransferase abnormal, and gamma-glutamyltransferase abnormal.
c Includes hypertension, blood pressure increased, hypertensive crisis, and hypertensive cardiomyopathy.
In addition, hypothyroidism was reported in patients treated with nintedanib capsules, more than placebo (1.1% vs. 0.6%). Alopecia was also reported in more patients treated with nintedanib capsules than placebo (0.8% vs. 0.4%).
Combination with Pirfenidone
Concomitant treatment with nintedanib and pirfenidone was investigated in an exploratory open-label, randomized (1:1) trial of nintedanib 150 mg twice daily with add-on pirfenidone (titrated to 801 mg three times a day) compared to nintedanib 150 mg twice daily alone in 105 randomized patients for 12 weeks. The primary endpoint was the percentage of patients with gastrointestinal adverse events from baseline to Week 12. Gastrointestinal adverse events were in line with the established safety profile of each component and were experienced in 37 (70%) patients treated with pirfenidone added to nintedanib versus 27 (53%) patients treated with nintedanib alone.
Diarrhea, nausea, vomiting, and abdominal pain (includes upper abdominal pain, abdominal discomfort, and abdominal pain) were the most frequent adverse events reported in 20 (38%) versus 16 (31%), in 22 (42%) versus 6 (12%), in 15 (28%) versus 6 (12%), and in 15 (28%) versus 7 (14%) patients treated with pirfenidone added to nintedanib versus nintedanib alone, respectively. More subjects reported AST or ALT elevations (greater than or equal to 3 times the upper limit of normal) when using pirfenidone in combination with nintedanib (n=3 (6%)) compared to nintedanib alone (n=0) [see Warnings and Precautions (
Chronic Fibrosing Interstitial Lung Diseases with a Progressive Phenotype
Nintedanib capsules were studied in a phase 3, double-blind, placebo-controlled trial (Study 5) in which 663 patients with chronic fibrosing ILDs with a progressive phenotype were randomized to receive nintedanib capsules 150 mg twice daily (n=332) or placebo (n=331) for at least 52 weeks. At 52 weeks, the median duration of exposure was 12 months for patients in both treatment arms. Subjects ranged in age from 27 to 87 years (median age of 67 years). The majority of patients were Caucasian (74%) or Asian (25%). Most patients were male (54%).
The most frequent serious adverse event reported in patients treated with nintedanib capsules, more than placebo, was pneumonia (4% vs. 3%). Adverse events leading to death were reported in 3% of patients treated with nintedanib capsules and in 5% of patients treated with placebo. No pattern was identified in the adverse events leading to death.
Adverse reactions leading to permanent dose reductions were reported in 33% of nintedanib capsules-treated patients and 4% of placebo-treated patients. The most frequent adverse reaction that led to permanent dose reduction in the patients treated with nintedanib capsules was diarrhea (16%).
Adverse reactions leading to discontinuation were reported in 20% of nintedanib capsules-treated patients and 10% of placebo-treated patients. The most frequent adverse reaction that led to discontinuation in nintedanib capsules-treated patients was diarrhea (6%).
The safety profile in patients with chronic fibrosing ILDs with a progressive phenotype treated with nintedanib capsules was consistent with that observed in IPF patients. In addition, the following adverse events were reported in nintedanib capsules more than placebo in chronic progressive fibrosing ILD: nasopharyngitis (13% vs. 12%), upper respiratory tract infection (7% vs 6%), urinary tract infection (6% vs. 4%), fatigue (10% vs. 6%), and back pain (6% vs. 5%).
Concomitant treatment with nintedanib and pirfenidone was investigated in an exploratory open-label, randomized (1:1) trial of nintedanib 150 mg twice daily with add-on pirfenidone (titrated to 801 mg three times a day) compared to nintedanib 150 mg twice daily alone in 105 randomized patients for 12 weeks. The primary endpoint was the percentage of patients with gastrointestinal adverse events from baseline to Week 12. Gastrointestinal adverse events were in line with the established safety profile of each component and were experienced in 37 (70%) patients treated with pirfenidone added to nintedanib versus 27 (53%) patients treated with nintedanib alone.
Diarrhea, nausea, vomiting, and abdominal pain (includes upper abdominal pain, abdominal discomfort, and abdominal pain) were the most frequent adverse events reported in 20 (38%) versus 16 (31%), in 22 (42%) versus 6 (12%), in 15 (28%) versus 6 (12%), and in 15 (28%) versus 7 (14%) patients treated with pirfenidone added to nintedanib versus nintedanib alone, respectively. More subjects reported AST or ALT elevations (greater than or equal to 3 times the upper limit of normal) when using pirfenidone in combination with nintedanib (n=3 (6%)) compared to nintedanib alone (n=0) [see Warnings and Precautions (
Chronic Fibrosing Interstitial Lung Diseases with a Progressive Phenotype
Nintedanib capsules were studied in a phase 3, double-blind, placebo-controlled trial (Study 5) in which 663 patients with chronic fibrosing ILDs with a progressive phenotype were randomized to receive nintedanib capsules 150 mg twice daily (n=332) or placebo (n=331) for at least 52 weeks. At 52 weeks, the median duration of exposure was 12 months for patients in both treatment arms. Subjects ranged in age from 27 to 87 years (median age of 67 years). The majority of patients were Caucasian (74%) or Asian (25%). Most patients were male (54%).
The most frequent serious adverse event reported in patients treated with nintedanib capsules, more than placebo, was pneumonia (4% vs. 3%). Adverse events leading to death were reported in 3% of patients treated with nintedanib capsules and in 5% of patients treated with placebo. No pattern was identified in the adverse events leading to death.
Adverse reactions leading to permanent dose reductions were reported in 33% of nintedanib capsules-treated patients and 4% of placebo-treated patients. The most frequent adverse reaction that led to permanent dose reduction in the patients treated with nintedanib capsules was diarrhea (16%).
Adverse reactions leading to discontinuation were reported in 20% of nintedanib capsules-treated patients and 10% of placebo-treated patients. The most frequent adverse reaction that led to discontinuation in nintedanib capsules-treated patients was diarrhea (6%).
The safety profile in patients with chronic fibrosing ILDs with a progressive phenotype treated with nintedanib capsules was consistent with that observed in IPF patients. In addition, the following adverse events were reported in nintedanib capsules more than placebo in chronic progressive fibrosing ILD: nasopharyngitis (13% vs. 12%), upper respiratory tract infection (7% vs 6%), urinary tract infection (6% vs. 4%), fatigue (10% vs. 6%), and back pain (6% vs. 5%).
3.2Postmarketing Experience
The following adverse reactions have been identified during postapproval use of nintedanib capsules. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Blood and Lymphatic System Disorders : Thrombocytopenia
Gastrointestinal Disorders : Pancreatitis
Hepatobiliary Disorders : Drug - induced liver injury
Nervous System Disorders : Posterior reversible encephalopathy syndrome
Renal and Urinary Disorders : Proteinuria
Skin and subcutaneous Tissue Disorders : Pruritus, rash
Vascular Disorders : Non-serious and serious bleeding events, some of which were fatal
4OVERDOSAGE
In IPF trials, one patient was inadvertently exposed to a dose of 600 mg daily for a total of 21 days. A non-serious adverse event (nasopharyngitis) occurred and resolved during the period of incorrect dosing, with no onset of other reported events. Overdosage was also reported in two patients in oncology studies who were exposed to a maximum of 600 mg twice daily for up to 8 days. Adverse events reported were consistent with the existing safety profile of nintedanib capsules. Both patients recovered. In case of overdosage, interrupt treatment and initiate general supportive measures as appropriate.
5DESCRIPTION
Nintedanib capsules contain nintedanib, a kinase inhibitor
Nintedanib esylate is a Greenish yellow to bright yellow powder with an empirical formula of C
6HOW SUPPLIED/STORAGE AND HANDLING
150 mg: brown colored, oblong shape soft gelatin capsules, imprinted with “N6” in black containing yellow colored suspension.They are packaged in HDPE bottles with a child-resistant closure, available as follows:
7PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Elevated Liver Enzymes and Drug-Induced Liver Injury
Advise patients that they will need to undergo liver function testing periodically. Advise patients to immediately report any symptoms of a liver problem (e.g., skin or the whites of eyes turn yellow, urine turns dark or brown (tea colored), pain on the right side of stomach, bleed or bruise more easily than normal, lethargy, loss of appetite) [see Warnings and Precautions (
Gastrointestinal Disorders
Inform patients that gastrointestinal disorders such as diarrhea, nausea, and vomiting were the most commonly reported gastrointestinal events occurring in patients who received nintedanib capsules. Advise patients that their healthcare provider may recommend hydration, antidiarrheal medications (e.g., loperamide), or anti-emetic medications to treat these side effects. Temporary dosage reductions or discontinuations may be required. Instruct patients to contact their healthcare provider at the first signs of diarrhea or for any severe or persistent diarrhea, nausea, or vomiting [see Warnings and Precautions (
Embryo-Fetal Toxicity
Counsel patients on pregnancy prevention and planning. Advise females of reproductive potential of the potential risk to a fetus and to avoid becoming pregnant while receiving treatment with nintedanib capsules. Advise females of reproductive potential to use highly effective contraception at initiation of, during treatment, and for at least 3 months after taking the last dose of nintedanib capsules. Advise women taking oral hormonal contraceptives who experience vomiting and/or diarrhea or other conditions where the drug absorption may be reduced to contact their doctor to discuss alternative highly effective contraception. Advise female patients to notify their doctor if they become pregnant or suspect they are pregnant during therapy with nintedanib capsules [see Warnings and Precautions (
Arterial Thromboembolic Events
Advise patients about the signs and symptoms of acute myocardial ischemia and other arterial thromboembolic events and the urgency to seek immediate medical care for these conditions [see Warnings and Precautions (
Risk of Bleeding
Bleeding events have been reported. Advise patients to report unusual bleeding [see Warnings and Precautions (
Gastrointestinal Perforation
Serious gastrointestinal perforation events have been reported. Advise patients to report signs and symptoms of gastrointestinal perforation [see Warnings and Precautions (
Nephrotic Range Proteinuria
Nephrotic range proteinuria has been reported. Advise patients to report signs and symptoms of proteinuria (e.g., fluid retention, foamy urine) [see Warnings and Precautions (
Lactation
Advise patients that breastfeeding is not recommended while taking nintedanib capsules [see Use in Specific Populations (
Smokers
Encourage patients to stop smoking prior to treatment with nintedanib capsules and to avoid smoking when using nintedanib capsules [see Clinical Pharmacology (
Administration
Instruct patients to take nintedanib capsules with food, to swallow nintedanib capsules capsules whole with liquid, and not to chew the capsules due to the bitter taste. Advise patients or caregivers not to open or crush nintedanib capsules capsules and to wash hands immediately and thoroughly if contact with the content of the capsule occurs. Advise patients to not make up for a missed dose [see Dosage and Administration (
Manufactured for:
Macleods Pharma USA, Inc.
Princeton, NJ 08540
Manufactured by:
Macleods Pharmaceuticals Ltd.
Plot no: M-50 to M-54A, SEZ,
Phase-II, Pithampur, MP 454774.
INDIA
Elevated Liver Enzymes and Drug-Induced Liver Injury
Advise patients that they will need to undergo liver function testing periodically. Advise patients to immediately report any symptoms of a liver problem (e.g., skin or the whites of eyes turn yellow, urine turns dark or brown (tea colored), pain on the right side of stomach, bleed or bruise more easily than normal, lethargy, loss of appetite) [see Warnings and Precautions (
Gastrointestinal Disorders
Inform patients that gastrointestinal disorders such as diarrhea, nausea, and vomiting were the most commonly reported gastrointestinal events occurring in patients who received nintedanib capsules. Advise patients that their healthcare provider may recommend hydration, antidiarrheal medications (e.g., loperamide), or anti-emetic medications to treat these side effects. Temporary dosage reductions or discontinuations may be required. Instruct patients to contact their healthcare provider at the first signs of diarrhea or for any severe or persistent diarrhea, nausea, or vomiting [see Warnings and Precautions (
Embryo-Fetal Toxicity
Counsel patients on pregnancy prevention and planning. Advise females of reproductive potential of the potential risk to a fetus and to avoid becoming pregnant while receiving treatment with nintedanib capsules. Advise females of reproductive potential to use highly effective contraception at initiation of, during treatment, and for at least 3 months after taking the last dose of nintedanib capsules. Advise women taking oral hormonal contraceptives who experience vomiting and/or diarrhea or other conditions where the drug absorption may be reduced to contact their doctor to discuss alternative highly effective contraception. Advise female patients to notify their doctor if they become pregnant or suspect they are pregnant during therapy with nintedanib capsules [see Warnings and Precautions (
Arterial Thromboembolic Events
Advise patients about the signs and symptoms of acute myocardial ischemia and other arterial thromboembolic events and the urgency to seek immediate medical care for these conditions [see Warnings and Precautions (
Risk of Bleeding
Bleeding events have been reported. Advise patients to report unusual bleeding [see Warnings and Precautions (
Gastrointestinal Perforation
Serious gastrointestinal perforation events have been reported. Advise patients to report signs and symptoms of gastrointestinal perforation [see Warnings and Precautions (
Nephrotic Range Proteinuria
Nephrotic range proteinuria has been reported. Advise patients to report signs and symptoms of proteinuria (e.g., fluid retention, foamy urine) [see Warnings and Precautions (
Lactation
Advise patients that breastfeeding is not recommended while taking nintedanib capsules [see Use in Specific Populations (
Smokers
Encourage patients to stop smoking prior to treatment with nintedanib capsules and to avoid smoking when using nintedanib capsules [see Clinical Pharmacology (
Administration
Instruct patients to take nintedanib capsules with food, to swallow nintedanib capsules capsules whole with liquid, and not to chew the capsules due to the bitter taste. Advise patients or caregivers not to open or crush nintedanib capsules capsules and to wash hands immediately and thoroughly if contact with the content of the capsule occurs. Advise patients to not make up for a missed dose [see Dosage and Administration (
Manufactured for:
Macleods Pharma USA, Inc.
Princeton, NJ 08540
Manufactured by:
Macleods Pharmaceuticals Ltd.
Plot no: M-50 to M-54A, SEZ,
Phase-II, Pithampur, MP 454774.
INDIA
Revised: May 2026
8SPL MEDGUIDE SECTION
Nintedanib (nin-ted-a-nib)
What is the most important information I should know about nintedanib capsules?
• Nintedanib capsules can cause birth defects or death to an unborn baby. Women should not become pregnant while taking nintedanib capsules. Women who are able to become pregnant should have a pregnancy test before starting treatment with nintedanib capsules.
• Women who are able to become pregnant should use highly effective birth control at the start of treatment, during treatment, and for at least 3 months after treatment. Talk with your doctor about what birth control method is right for you during this time.
• Birth control pills may not work as well in women having vomiting, diarrhea, or other problems reducing the drug absorption. If you have any of these problems, talk with your doctor about which highly effective birth control method is right for you.
• If you become pregnant or think you are pregnant while taking nintedanib capsules, tell your doctor right away.
What are nintedanib capsules?
• Nintedanib capsule is a prescription medicine used:
o to treat adults with a lung disease called idiopathic pulmonary fibrosis (IPF).
o to treat adults with a long-lasting (chronic) interstitial lung disease in which lung fibrosis continues to worsen (progress).
• It is not known if nintedanib capsules are safe and effective in children.
What should I tell my doctor before taking nintedanib capsules?
Before you take nintedanib capsules, tell your doctor about all of your medical conditions, including if you:
• have liver problems.
• have heart problems.
• have a history of blood clots.
• have a bleeding problem or a family history of a bleeding problem.
• have had recent surgery in your stomach (abdominal) area.
• are a smoker.
• are pregnant or plan to become pregnant. Nintedanib capsules can harm your unborn baby. Nintedanib capsules can cause birth defects or death to an unborn baby. See “What is the most important information I should know about nintedanib capsules?”
• are breastfeeding or plan to breastfeed. It is not known if nintedanib passes into your breast milk. You should not breastfeed while taking nintedanib capsules.
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements such as St. John’s wort. Keep a list of the medicines you take and show it to your doctor and pharmacist when you get a new medicine.
How should I take nintedanib capsules?
• Take nintedanib capsules exactly as your doctor tells you to take it.
• Your doctor will tell you how much nintedanib capsules to take and when to take it.
• Take nintedanib capsules with food. Swallow the nintedanib capsules capsules whole with a liquid.
• Do not chew, crush, or open nintedanib capsules capsules. If you or your caregiver accidently comes in contact with the content of the capsule, wash hands well right away.
• If you miss a dose of nintedanib capsules, take your next dose at your regular time. Do not take the missed dose.
• Do not take more than 300 mg of nintedanib capsules in 1 day.
• If you take too much nintedanib capsules, call your doctor or go to the nearest hospital emergency room right away.
• Your doctor should do certain blood tests before you start taking nintedanib capsules.
What are the possible side effects of nintedanib capsules?
• liver problems. Call your doctor right away if you have unexplained symptoms such as yellowing of your skin or the white part of your eyes (jaundice), dark or brown (tea colored) urine, pain on the upper right side of your stomach area (abdomen), bleeding or bruising more easily than normal, feeling tired, or loss of appetite. Your doctor will do blood tests to check how well your liver is working before starting and during your treatment with nintedanib capsules.
• diarrhea, nausea, and vomiting. While you are taking nintedanib capsules, your doctor may recommend that you drink fluids or take medicine to treat these side effects. Tell your doctor if you have diarrhea, nausea, or vomiting or if these symptoms do not go away or become worse. Tell your doctor if you are taking over-the-counter laxatives, stool
softeners, and other medicines or dietary supplements that can cause diarrhea.
• heart attack. Tell your doctor right away if you have symptoms of a heart problem. These symptoms may include chest pain or pressure, pain in your arms, back, neck or jaw, or shortness of breath.
• stroke. Tell your doctor right away if you have symptoms of a stroke. These symptoms may include numbness or weakness on 1 side of your body, trouble talking, headache, or dizziness.
• bleeding problems. nintedanib capsules may increase your chances of having bleeding problems. Tell your doctor if you have unusual bleeding, bruising, or wounds that do not heal. Tell your doctor if you are taking a blood thinner, including prescription blood thinners and over-the-counter aspirin.
• tear in your stomach or intestinal wall (perforation). nintedanib capsules may increase your chances of having a tear in your stomach or intestinal wall. Tell your doctor if you have pain or swelling in your stomach area.
• increased protein in your urine (proteinuria). nintedanib capsules may increase your chances of having protein in your urine. Tell your doctor if you have any signs and symptoms of protein in the urine such as foamy urine, swelling, including in your hands, arms, legs, or feet, or sudden weight gain.
The most common side effects of nintedanib capsules are diarrhea, nausea, stomach pain, vomiting, liver problems, decreased appetite, headache, weight loss, and high blood pressure.
These are not all the possible side effects of nintedanib capsules. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store nintedanib capsules?
• Store nintedanib capsules at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep nintedanib capsules dry and protect from high heat.
Keep nintedanib capsules and all medicines out of the reach of children.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use nintedanib capsules for a condition for which it was not prescribed. Do not give nintedanib capsules to other people, even if they have the same symptoms you have. It may harm them. This Patient Information leaflet summarizes the most important information about nintedanib capsules. If you would like more information, talk to your doctor. You can ask your pharmacist or doctor for information about nintedanib capsules that is written for health professionals.
What are the ingredients in nintedanib capsules? nintedanib
Inactive ingredients: Fill Material: polyethylene glycol, caprylocaproyl polyoxyl-8 glycerides, triglycerides. Capsule Shell: gelatin, glycerin, titanium dioxide, red ferric oxide, yellow ferric oxide, Imprinting Ink: shellac glaze, ferrosoferric oxide/black iron oxide, propylene glycol, ammonium hydroxide.
• Nintedanib capsules can cause birth defects or death to an unborn baby. Women should not become pregnant while taking nintedanib capsules. Women who are able to become pregnant should have a pregnancy test before starting treatment with nintedanib capsules.
• Women who are able to become pregnant should use highly effective birth control at the start of treatment, during treatment, and for at least 3 months after treatment. Talk with your doctor about what birth control method is right for you during this time.
• Birth control pills may not work as well in women having vomiting, diarrhea, or other problems reducing the drug absorption. If you have any of these problems, talk with your doctor about which highly effective birth control method is right for you.
• If you become pregnant or think you are pregnant while taking nintedanib capsules, tell your doctor right away.
What are nintedanib capsules?
• Nintedanib capsule is a prescription medicine used:
o to treat adults with a lung disease called idiopathic pulmonary fibrosis (IPF).
o to treat adults with a long-lasting (chronic) interstitial lung disease in which lung fibrosis continues to worsen (progress).
• It is not known if nintedanib capsules are safe and effective in children.
What should I tell my doctor before taking nintedanib capsules?
Before you take nintedanib capsules, tell your doctor about all of your medical conditions, including if you:
• have liver problems.
• have heart problems.
• have a history of blood clots.
• have a bleeding problem or a family history of a bleeding problem.
• have had recent surgery in your stomach (abdominal) area.
• are a smoker.
• are pregnant or plan to become pregnant. Nintedanib capsules can harm your unborn baby. Nintedanib capsules can cause birth defects or death to an unborn baby. See “What is the most important information I should know about nintedanib capsules?”
• are breastfeeding or plan to breastfeed. It is not known if nintedanib passes into your breast milk. You should not breastfeed while taking nintedanib capsules.
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements such as St. John’s wort. Keep a list of the medicines you take and show it to your doctor and pharmacist when you get a new medicine.
How should I take nintedanib capsules?
• Take nintedanib capsules exactly as your doctor tells you to take it.
• Your doctor will tell you how much nintedanib capsules to take and when to take it.
• Take nintedanib capsules with food. Swallow the nintedanib capsules capsules whole with a liquid.
• Do not chew, crush, or open nintedanib capsules capsules. If you or your caregiver accidently comes in contact with the content of the capsule, wash hands well right away.
• If you miss a dose of nintedanib capsules, take your next dose at your regular time. Do not take the missed dose.
• Do not take more than 300 mg of nintedanib capsules in 1 day.
• If you take too much nintedanib capsules, call your doctor or go to the nearest hospital emergency room right away.
• Your doctor should do certain blood tests before you start taking nintedanib capsules.
What are the possible side effects of nintedanib capsules?
• liver problems. Call your doctor right away if you have unexplained symptoms such as yellowing of your skin or the white part of your eyes (jaundice), dark or brown (tea colored) urine, pain on the upper right side of your stomach area (abdomen), bleeding or bruising more easily than normal, feeling tired, or loss of appetite. Your doctor will do blood tests to check how well your liver is working before starting and during your treatment with nintedanib capsules.
• diarrhea, nausea, and vomiting. While you are taking nintedanib capsules, your doctor may recommend that you drink fluids or take medicine to treat these side effects. Tell your doctor if you have diarrhea, nausea, or vomiting or if these symptoms do not go away or become worse. Tell your doctor if you are taking over-the-counter laxatives, stool
softeners, and other medicines or dietary supplements that can cause diarrhea.
• heart attack. Tell your doctor right away if you have symptoms of a heart problem. These symptoms may include chest pain or pressure, pain in your arms, back, neck or jaw, or shortness of breath.
• stroke. Tell your doctor right away if you have symptoms of a stroke. These symptoms may include numbness or weakness on 1 side of your body, trouble talking, headache, or dizziness.
• bleeding problems. nintedanib capsules may increase your chances of having bleeding problems. Tell your doctor if you have unusual bleeding, bruising, or wounds that do not heal. Tell your doctor if you are taking a blood thinner, including prescription blood thinners and over-the-counter aspirin.
• tear in your stomach or intestinal wall (perforation). nintedanib capsules may increase your chances of having a tear in your stomach or intestinal wall. Tell your doctor if you have pain or swelling in your stomach area.
• increased protein in your urine (proteinuria). nintedanib capsules may increase your chances of having protein in your urine. Tell your doctor if you have any signs and symptoms of protein in the urine such as foamy urine, swelling, including in your hands, arms, legs, or feet, or sudden weight gain.
The most common side effects of nintedanib capsules are diarrhea, nausea, stomach pain, vomiting, liver problems, decreased appetite, headache, weight loss, and high blood pressure.
These are not all the possible side effects of nintedanib capsules. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store nintedanib capsules?
• Store nintedanib capsules at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep nintedanib capsules dry and protect from high heat.
Keep nintedanib capsules and all medicines out of the reach of children.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use nintedanib capsules for a condition for which it was not prescribed. Do not give nintedanib capsules to other people, even if they have the same symptoms you have. It may harm them. This Patient Information leaflet summarizes the most important information about nintedanib capsules. If you would like more information, talk to your doctor. You can ask your pharmacist or doctor for information about nintedanib capsules that is written for health professionals.
What are the ingredients in nintedanib capsules? nintedanib
Inactive ingredients: Fill Material: polyethylene glycol, caprylocaproyl polyoxyl-8 glycerides, triglycerides. Capsule Shell: gelatin, glycerin, titanium dioxide, red ferric oxide, yellow ferric oxide, Imprinting Ink: shellac glaze, ferrosoferric oxide/black iron oxide, propylene glycol, ammonium hydroxide.
Manufactured for:
Macleods Pharma USA, Inc.
Princeton, NJ 08540
Manufactured by:
Macleods Pharmaceuticals Ltd.
Plot no: M-50 to M-54A, SEZ,
Phase-II, Pithampur, MP 454774.
INDIA
This Patient Information has been approved by the U.S. Food and Drug Administration.
Revised: May 2026
9PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Nintedanib Capsules 100 mg
Nintedanib Capsules 150 mg
NDC 33342-551-09
