Ritlecitinib Side Effects

Medically reviewed by Drugs.com. Last updated on Dec 8, 2024.

Applies to ritlecitinib: oral capsule.

Precautions

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if this medicine is working properly and to decide whether you should continue to use it. Blood tests are needed to check for unwanted effects.

You will need to have a skin test for tuberculosis before you start using this medicine. Tell your doctor if you or anyone in your home has ever had a positive reaction to a tuberculosis skin test.

Your body's ability to fight infections may be reduced while you are using ritlecitinib. It is very important that you call your doctor at the first sign of an infection. Check with your doctor right away if you have a fever, chills, cough, flu-like symptoms, or unusual tiredness or weakness.

This medicine may increase your risk of serious heart or blood vessel problems (eg, heart attack, stroke), especially in patients with rheumatoid arthritis who are 50 years of age and older and with a heart or blood vessel disease. Call your doctor right away if you have chest pain or discomfort, confusion, difficulty in speaking, double vision, headache, inability to move arms, legs, or facial muscles, nausea, pain or discomfort in the arms, jaw, back, or neck, sweating, trouble breathing, or vomiting.

This medicine may increase your risk of cancer (eg, lymphoma, lung cancer, non-melanoma skin cancer). Tell your doctor right away if you have black, tarry stools, general feeling of illness, swollen glands, weight loss, yellow skin and eyes, persistent non-healing sore, reddish patch or irritated area, shiny bump, pink growth, or white, yellow or waxy scar-like area on the skin.

This medicine may increase your risk of developing blood clots (eg, arterial thrombosis, deep vein thrombosis, pulmonary embolism), especially in patients with rheumatoid arthritis who are 50 years of age and older and with a heart or blood vessel disease. Check with your doctor right away if you have anxiety, chest pain, cough, dizziness, lightheadedness, or fainting, fast heartbeat, pain, redness, or swelling in the arm or leg, pains in the chest, groin, or legs, especially calves of the legs, severe headaches, sudden loss of coordination, sudden onset of slurred speech, sudden vision changes, or trouble breathing.

While you are being treated with ritlecitinib, and after you stop treatment with it, do not have any immunizations (vaccines) without your doctor's approval. Ritlecitinib may lower your body's resistance and there is a chance you might get the infection the vaccine is meant to prevent. In addition, you should not be around other persons living in your household who receive live virus vaccines because there is a chance they could pass the virus on to you. Some examples of live vaccines include measles, mumps, influenza (nasal flu vaccine), poliovirus (oral form), rotavirus, and rubella. Do not get close to them and do not stay in the same room with them for very long. If you have questions about this, talk to your doctor.

This medicine can cause serious allergic reaction, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Check with your doctor right away if you have chest tightness, cough, difficulty swallowing, dizziness, fast heartbeat, hives, itching, skin rash, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue, or unusual tiredness or weakness.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Common side effects of ritlecitinib

Some side effects of ritlecitinib 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:

Serious side effects of ritlecitinib

Along with its needed effects, ritlecitinib 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 ritlecitinib:

For healthcare professionals

Applies to ritlecitinib: oral capsule.

General adverse events

The most frequently reported adverse reactions included headache, diarrhea, acne, rash, urticaria, folliculitis, pyrexia, atopic dermatitis, dizziness, increased blood creatine phosphokinase, herpes zoster, decreased RBC count, stomatitis, and upper respiratory tract infections.^[Ref]

Cardiovascular

• Frequency not reported: Acute myocardial infarction, thromboembolic events

Dermatologic

• Common (1% to 10%): Acne, atopic dermatitis, folliculitis, rash, urticaria
• Frequency not reported: Multidermatomal herpes zoster^[Ref]

Acne included acne and pustular acne.

Rash included rash and allergic dermatitis.^[Ref]

Gastrointestinal

• Very common (10% or more): Diarrhea (up to 10%)
• Common (1% to 10%): Stomatitis, upper abdominal pain
• Frequency not reported: Appendicitis^[Ref]

Diarrhea included diarrhea and frequent bowel movements.^[Ref]

Hematologic

• Common (1% to 10%): Decreased RBC count
• Uncommon (0.1% to 1%): Decreased platelet count, decreased lymphocyte counts^[Ref]

Hepatic

• Uncommon (0.1% to 1%): Increased ALT, increased AST
• Frequency not reported: Liver enzyme elevations^[Ref]

Musculoskeletal

• Common (1% to 10%): Increased blood creatine phosphokinase, ligament sprain

Nervous system

• Very common (10% or more): Headache (up to 10.8%)
• Common (1% to 10%): Dizziness^[Ref]

Headache included headache and migraine.^[Ref]

Ocular

• Frequency not reported: Retinal artery occlusion

Oncologic

• Frequency not reported: Malignancy/breast cancer^[Ref]

Other

• Very common (10% or more): Infections (up to 51%)
• Common (1% to 10%): Fatigue, herpes zoster, pyrexia, severe acute respiratory syndrome coronavirus 2 test positive
• Frequency not reported: Sepsis^[Ref]

Respiratory

• Very common (10% or more): Nasopharyngitis (10%)
• Common (1% to 10%): COVID-19 infection, oropharyngeal pain, upper respiratory tract infections
• Frequency not reported: Pulmonary embolism

COVID-19 infection included pneumonia.

See also:

Further information

Ritlecitinib side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer