Litfulo Side Effects
Generic name: ritlecitinib
Medically reviewed by Drugs.com. Last updated on Oct 12, 2023.
Note: This document contains side effect information about ritlecitinib. Some dosage forms listed on this page may not apply to the brand name Litfulo.
Applies to ritlecitinib: oral capsule.
Warning
Oral route (Capsule)
Warning: Serious Infections, Mortality, Malignancy, Major Adverse Cardiovascular Events (MACE) and ThrombosisIncreased 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.
Serious side effects of Litfulo
Along with its needed effects, ritlecitinib (the active ingredient contained in Litfulo) 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
- 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
Other side effects of Litfulo
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
Less common
- Blemishes on the skin
- pimples
- swelling or inflammation of the mouth
For Healthcare Professionals
Applies to ritlecitinib: oral capsule.
General
The most frequently reported adverse reactions (with an incidence of 1% or greater) include headache, diarrhea, acne, rash, urticaria, folliculitis, pyrexia, atopic dermatitis, dizziness, increased blood creatine phosphokinase, herpes zoster, decreased red blood cell count, and stomatitis.[Ref]
Dermatologic
Common (1% to 10%): Acne (acne and acne pustular), dermatitis atopic, folliculitis, rash (rash and dermatitis allergic), urticaria[Ref]
Gastrointestinal
Very common (10% or more): Diarrhea (diarrhea and frequent bowel movements) (10%)
Common (1% to 10%): Stomatitis[Ref]
Hematologic
Common (1% to 10%): Decreased red blood cell count
Rare (0.01% to 0.1%): Decreased platelet count, decreased lymphocyte counts, thromboembolic events[Ref]
Hepatic
Frequency not reported: Liver enzyme elevations[Ref]
Oncologic
Common (1% to 10%): Malignancy[Ref]
Other
Common (1% to 10%): Increased blood creatine phosphokinase, herpes zoster, pyrexia[Ref]
Nervous system
Very common (10% or more): Headache (headache and migraine) (10.8%)
Common (1% to 10%): Dizziness[Ref]
Frequently asked questions
More about Litfulo (ritlecitinib)
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- Drug class: multikinase inhibitors
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References
1. Product Information. Litfulo (ritlecitinib). Pfizer U.S. Pharmaceuticals Group. 2023.
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Some side effects may not be reported. You may report them to the FDA.