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Ritlecitinib Side Effects

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

Applies to ritlecitinib: oral capsule.

Important warnings This medicine can cause some serious health issues

Oral route (capsule)

Warning: Serious Infections, Mortality, Malignancy, Major Adverse Cardiovascular Events (MACE) and Thrombosis. Increased risk of serious bacterial, fungal, viral and opportunistic infections leading to hospitalization or death, including tuberculosis (TB).

Interrupt treatment if serious infection occurs until the infection is controlled.

Ritlecitinib should not be given to patients with active tuberculosis.

Test for latent TB before and during therapy; treat latent TB prior to use.

Monitor all patients for active TB during treatment, even patients with initial negative, latent TB test.Higher rate of all-cause mortality, including sudden cardiovascular death with another Janus kinase inhibitor (JAK) vs.

TNF blockers in rheumatoid arthritis (RA) patients.

Ritlecitinib is not approved for use in RA patients.Malignancies have occurred in patients treated with ritlecitinib.

Higher rate of lymphomas and lung cancers with another JAK inhibitor vs.

TNF blockers in RA patients.Higher rate of MACE (defined as cardiovascular death, myocardial infarction, and stroke) with another JAK inhibitor vs.

TNF blockers in RA patients.Thrombosis has occurred in patients treated with ritlecitinib.

Increased incidence of pulmonary embolism, venous and arterial thrombosis with another JAK inhibitor vs.

TNF blockers.

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:

More common side effects

Less common side effects

  • blemishes on the skin
  • pimples
  • swelling or inflammation of the mouth

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:

Less common side effects

  • burning, itching, and pain in hairy areas, pus at the root of hair
  • painful blisters on the trunk of the body

Incidence not known

  • anxiety
  • black, tarry stools
  • chest pain, discomfort, or tightness
  • confusion
  • cough or hoarseness
  • coughing or spitting up blood
  • difficulty breathing
  • difficulty in speaking
  • dizziness or lightheadedness
  • double vision
  • fainting
  • fast heartbeat
  • fever or chills
  • general feeling of illness
  • headache
  • hives, itching, skin rash
  • inability to move the arms, legs, or facial muscles
  • inability to speak
  • lower back or side pain
  • muscle aches
  • nausea
  • night sweats
  • pain, redness, or swelling in the arm or leg
  • pain or discomfort in the arms, jaw, back, or neck
  • painful or difficult urination
  • persistent non-healing sore
  • pink growth
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • reddish patch or irritated area
  • shiny bump
  • slow speech
  • sore throat
  • sudden high fever or low grade fever for months
  • sweating
  • swollen glands
  • tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over the affected area
  • unusual tiredness or weakness
  • vomiting
  • weight loss
  • white, yellow, or waxy scar-like area
  • yellow skin and eyes
Managing side effects (general information)

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

Dermatologic

Acne included acne and pustular acne.

Rash included rash and allergic dermatitis.[Ref]

Gastrointestinal

Diarrhea included diarrhea and frequent bowel movements.[Ref]

Hematologic

Hepatic

Musculoskeletal

Nervous system

Headache included headache and migraine.[Ref]

Ocular

Oncologic

Other

Respiratory

COVID-19 infection included pneumonia.

References

1. Cerner Multum, Inc. "Australian Product Information."

2. (2023) "Product Information. Litfulo (ritlecitinib)." Pfizer U.S. Pharmaceuticals Group

3. (2024) "Product Information. Litfulo (ritlecitinib)." Pfizer Ltd

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