the hand made Esbriet Side Effects Generic Name: pirfenidone Overview Side Effects Dosage Professional Interactions More Pregnancy Warnings User Reviews Drug Images Support Group Q & A Compare Alternatives Pricing & Coupons Note: This document contains side effect information about pirfenidone. Some of the dosage forms listed on this page may not apply to the brand name Esbriet. For the Consumer Applies to pirfenidone: oral capsule, oral tablet Along with its needed effects, pirfenidone (the active ingredient contained in Esbriet) 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 pirfenidone: More common Diarrhea itching or skin rash nausea redness or other discoloration of the skin severe sunburn stomach discomfort, upset, or pain vomiting Incidence not known Cough or hoarseness fever with or without chills general feeling of tiredness or weakness large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs lower back or side pain painful or difficult urination sore throat sores, ulcers, or white spots on the lips or in the mouth unusual bleeding or bruising Some side effects of pirfenidone 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 Acid or sour stomach body aches or pain change in taste dizziness ear congestion headache heartburn or indigestion increased sensitivity of the skin to sunlight joint or muscle pain lack or loss of strength loss of appetite pain or tenderness around the eyes and cheekbones sneezing stuffy or runny nose trouble sleeping unusual tiredness or weakness weight loss For Healthcare Professionals Applies to pirfenidone: oral capsule, oral tablet Hepatic Common (1% to 10%): Increased ALT, increased AST, increased gamma glutamyl transferase Postmarketing reports: Increased bilirubin in combination with increased ALT and AST [ Ref ] Hypersensitivity Very common (10% or more): Photosensitivity reaction (up to 12.2%) Postmarketing reports: Angioedema [ Ref ] Dermatologic Very common (10% or more): Rash (up to 30%) Common (1% to 10%): Pruritus, erythema, dry skin, erythemous/macular/pruritic rash, sunburn [ Ref ] Gastrointestinal Very common (10% or more): Nausea (up to 36%), diarrhea (up to 26%), abdominal pain/distension/discomfort (up to 24%), dyspepsia (up to 19%), vomiting (up to 13%), gastroesophageal reflux disease (up to 11%) Common (1% to 10%): Gastritis, constipation, flatulence [ Ref ] Nervous system Very common (10% or more): Headache (up to 22%), dizziness (up to 18%) Common (1% to 10%): Somnolence, dysgeusia [ Ref ] Other Very common (10% or more): Fatigue (up to 26%) Common (1% to 10%): Asthenia, non-cardiac chest pain [ Ref ] Metabolic Very common (10% or more): Anorexia (up to 13%), decreased weight (up to 10%) Common (1% to 10%): Decreased appetite [ Ref ] Cardiovascular Common (1% to 10%): Hot flush [ Ref ] Genitourinary Common (1% to 10%): Urinary tract infection [ Ref ] Hematologic Postmarketing reports: Agranulocytosis [ Ref ] Musculoskeletal Very common (10% or more): Arthralgia (up to 10%) Common (1% to 10%): Myalgia [ Ref ] Psychiatric Very common (10% or more): Insomnia (up to 10%) [ Ref ] Respiratory Very common (10% or more): Upper respiratory tract infection (up to 27%), sinusitis (up to 11%) Common (1% to 10%): Cough [ Ref ] References 1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0 2. "Product Information. Esbriet (pirfenidone)." Intermune Inc, Brisbane, CA. Some side effects of Esbriet may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA . Next Dosage Print this page More about Esbriet (pirfenidone) Side Effects During Pregnancy Dosage Information Drug Images Drug Interactions Compare Alternatives Support Group Pricing & Coupons En Español 0 Reviews Add your own review/rating Drug class: miscellaneous uncategorized agents Consumer resources Esbriet Esbriet (Advanced Reading) Professional resources Esbriet (AHFS Monograph) Esbriet (FDA) Related treatment guides Idiopathic Pulmonary Fibrosis 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. Drug Status Rx Availability Prescription only C Pregnancy Category Risk cannot be ruled out N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Manufacturer Genentech, Inc. Drug Class Miscellaneous uncategorized agents Related Drugs Idiopathic Pulmonary Fibrosis Ofev , nintedanib , pirfenidone , Actimmune , interferon gamma-1b , More... Esbriet Rating No Reviews - Be the first! No Reviews - Be the first! Not Rated - Be the first! Esbriet Images Esbriet 267 mg (InterMune 267 mg ) View all images without borderlines
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