Patient information: uses, side effects, how to take - Rifapentine
What is the most important information I should know about rifapentine tablets?
Rifapentine tablets may cause serious side effects, including:
•Liver problems. Rifapentine tablets may cause serious liver problems. Your doctor may do a blood test to check your liver function before and while you take rifapentine tablets. Stop taking rifapentine tablets and call your doctor right away if you have any of the following signs and symptoms of liver problems:
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•Allergic reactions and flu-like symptoms. Allergic reactions and flu-like symptoms have happened in some people taking rifapentine tablets. Signs and symptoms of an allergic reaction may include:
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Signs and symptoms of a flu-like reaction may include:
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•Severe skin reactions. Serious skin reactions such as Stevens-Johnson syndrome (SJS) and drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome have happened in some people taking rifapentine tablets.
Stop taking rifapentine tablets right away and call your doctor or get emergency help if you have any of the following symptoms:
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What are rifapentine tablets?
Rifapentine tablets are a prescription medicine used with other anti-tuberculosis (TB) medicines to:
•treat active tuberculosis disease of the lung in people age 12 years and older.
•prevent progression of inactive (latent) tuberculosis infection to active tuberculosis disease in people age 2 years and older.
Rifapentine tablets should not be used:
•alone to treat people with active or latent TB
•in people with active TB who had taken the medicines rifampin or isoniazid in the past and did not respond (resistant)
•in people who had been exposed to patients with TB that cannot be treated with isoniazid or rifampin
Rifapentine tablets are safe and effective in children older than 2 years of age who have inactive (latent TB), but it is not known if rifapentine tablets are safe and effective for use in the treatment of active TB in children under 12 years of age.
Who should not take rifapentine tablets?
•Do not take rifapentine tablets if you are allergic to a group of medicines called rifamycins.
What should I tell my doctor before taking rifapentine tablets?
Before taking rifapentine tablets, tell your doctor about all of your medical conditions, including if you:
•have active TB disease.
•know that you have TB that is resistant to treatment with some medicines.
•have HIV infection or taking medicines to treat HIV infection.
- have liver problems.
•have a condition called porphyria.
•are pregnant or planning to become pregnant. It is not known if rifapentine tablets will harm your unborn baby.
•are breastfeeding or plan to breastfeed. It is not known if rifapentine passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby while taking rifapentine tablets.
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Using rifapentine tablets with other medicines may affect each other causing serious side effects. Rifapentine tablets may affect the way other medicines work, and other medicines may affect how rifapentine tablets works. Especially tell your doctor if you take medicines to treat HIV infection or oral contraceptives.
Ask your doctor or pharmacist for a list of these medicines if you are not sure.
Know the medicines you take. Keep a list of them to show your doctor or pharmacist when you get a new medicine.
How should I take rifapentine tablets?
•Take rifapentine tablets exactly as your doctor tells you to take it.
It is important to take all of your rifapentine tablets and your other TB medicines. Do not skip doses. Skipping doses may cause rifapentine tablets to not work as well and may increase the chance that your TB will not be treatable by rifapentine tablets or other medicines.
•Take rifapentine tablets with food.
If you cannot swallow rifapentine tablets whole, they can be crushed and mixed with small amount of semisolid food. Be sure to take all of the semisolid food with rifapentine tablets in it right away.
What are possible side effects of rifapentine tablets?
Rifapentine tablets may cause serious side effects, including:
•see "What is the most important information I should know about rifapentine tablets?"
•relapse of your TB symptoms. Active TB disease may return after improvement (relapse) in some people, especially people who do not take rifapentine tablets exactly as their doctor tells them to. It is important that you take rifapentine tablets exactly as your doctor tells you to. Your doctor should check you for worsening signs and symptoms of your TB while you take rifapentine tablets.
•change in the normal color of your skin, mouth and body fluids. Rifapentine tablets may cause your skin, teeth, tongue, urine, feces, saliva, sputum, tears, sweat, and breast milk to turn a red-orange color. Contact lenses or dentures may become permanently stained.
•diarrhea. A type of diarrhea called Clostridioides difficile–associated diarrhea (CDAD) may occur during or after taking antibiotics, including rifapentine tablets. The severity of CDAD can range from mild diarrhea to severe diarrhea that may cause death (fatal colitis). Tell your doctor right away if you have diarrhea while you take or after you stop taking rifapentine tablets.
•worsening of a condition called porphyria.
The most common side effects of rifapentine tablets include: allergic reactions and flu-like symptoms; abnormalities such as low red blood cells, low white blood cells, coughing up blood, cough, excessive number of platelets in the blood, increased sweating, high liver function tests, back pain, rash, decreased appetite, joint pain, increased blood urea, and headache.
Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of rifapentine tablets. 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 rifapentine tablets?
•Store rifapentine tablets at room temperature between 68°F to 77°F (20°C to 25°C).
•Keep rifapentine tablets dry and away from heat.
•Keep rifapentine tablets and all medicines out of reach of children.
General information about the safe and effective use of rifapentine tablets.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use rifapentine tablets for a condition for which it was not prescribed. Do not give rifapentine tablets to other people, even if they have the same symptoms you have. It may harm them.
This Medication Guide summarizes the most important information about rifapentine tablets. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about rifapentine tablets that is written for healthcare professionals.
What are the ingredients in rifapentine tablets?
Active ingredient: rifapentine
Inactive ingredients: calcium stearate, colloidal silicon dioxide, disodium EDTA, hydroxypropyl cellulose, iron oxide red, low substituted hydroxy propyl cellulose, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, sodium ascorbate, sodium lauryl sulfate, sodium starch glycolate, talc, titanium dioxide and polyvinyl alcohol - part. hydrolyzed.
Manufactured for:
Macleods Pharma USA, Inc.
Princeton, NJ 08540
Manufacturer:
Macleods Pharmaceuticals Limited
At Oxalis Labs
Baddi, Himachal Pradesh-174101, India
For more information, call 1-888-943-3210 or 1-855-926-3384.
All trademarks are the property of their respective owners.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Revised: June 2026