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Abrocitinib Side Effects

Medically reviewed by Drugs.com. Last updated on Apr 4, 2023.

Applies to abrocitinib: oral tablet.

Warning

Oral route (Tablet)

Serious InfectionsPatients treated with abrocitinib may be at increased risk for developing serious infections that may lead to hospitalization or death. The most frequent serious infection reported with abrocitinib were herpes simplex, herpes zoster, and pneumonia.If a serious or opportunistic infection develops, discontinue abrocitinib and control the infection.Reported infections from Janus kinase (JAK) inhibitors used to treat inflammatory conditions:Active tuberculosis, which may present with pulmonary or extrapulmonary disease. 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.Invasive fungal infections, including cryptococcosis and pneumocystosis. Patients with invasive fungal infections may present with disseminated, rather than localized disease.Bacterial, viral, including herpes zoster, and other infections due to opportunistic pathogens.Avoid use of abrocitinib in patients with an active, serious infection including localized infections. The risks and benefits of treatment with abrocitinib should be carefully considered prior to initiating therapy in patients with chronic or recurrent infections.Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with abrocitinib, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy.MortalityIn a large, randomized, postmarketing safety study in rheumatoid arthritis (RA) patients 50 years of age and older with at least one cardiovascular risk factor comparing another JAK inhibitor to TNF blocker treatment, a higher rate of all-cause mortality, including sudden cardiovascular death, was observed with the JAK inhibitor. Abrocitinib is not approved for use in RA patients.MalignanciesMalignancies were reported in patients treated with abrocitinib. Lymphoma and other malignancies have been observed in patients receiving JAK inhibitors used to treat inflammatory conditions. In RA patients treated with another JAK inhibitor, a higher rate of malignancies (excluding non-melanoma skin cancer [NMSC]) was observed when compared with TNF blockers. Patients who are current or past smokers are at additional increased risks.Major Adverse Cardiovascular EventsMajor adverse cardiovascular events were reported in patients treated with abrocitinib. In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with another JAK inhibitor, a higher rate of major adverse cardiovascular events (MACE) (defined as cardiovascular death, myocardial infarction, and stroke), was observed when compared with TNF blockers. Patients who are current or past smokers are at additional increased risk. Discontinue abrocitinib in patients that have experience a myocardial infarction or stroke.ThrombosisDeep vein thrombosis (DVT) and pulmonary embolism (PE) have been reported in patients treated with abrocitinib. Thrombosis, including PE, DVT, and arterial thrombosis have been reported in patients receiving JAK inhibitors used to treat inflammatory conditions. Many of these adverse reactions were serious and some resulted in death. In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with another JAK inhibitor, a higher rate of thrombosis was observed when compared with TNF blockers. Avoid abrocitinib in patients at risk. If symptoms of thrombosis occur, discontinue abrocitinib and treat appropriately.

Serious side effects of Abrocitinib

Along with its needed effects, abrocitinib 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 abrocitinib:

Less common

Rare

Incidence not known

Other side effects of Abrocitinib

Some side effects of abrocitinib 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

For Healthcare Professionals

Applies to abrocitinib: oral tablet.

General

The most common adverse reactions were headache, dizziness, fatigue, nausea, vomiting, oropharyngeal pain, upper abdominal pain, abdominal discomfort, nasopharyngitis, gastroenteritis, impetigo, influenza, hypertension, acne, contact dermatitis, herpes simplex infection, herpes zoster infection, increased blood creatine phosphokinase, urinary tract infection, and thrombocytopenia.[Ref]

Cardiovascular

Common (1% to 10%): Hypertension

Uncommon (0.1% to 1%): Pulmonary embolism, deep venous thrombosis, major adverse cardiovascular events[Ref]

Other

Very common (10% or more): Overall infection (up to 26%)

Common (1% to 10%): Fatigue, serious infection, herpes simplex, herpes zoster, influenza, creatinine phosphokinase elevations[Ref]

Herpes simplex also included oral herpes, ophthalmic herpes, herpes dermatitis, genital herpes.[Ref]

Oncologic

Uncommon (0.1% to 1%): Malignancies[Ref]

Hematologic

Common (1% to 10%): Lymphopenia

Uncommon (0.1% to 1%): Thrombocytopenia[Ref]

Gastrointestinal

Very common (10% or more): Nausea (up to 14.5%)

Common (1% to 10%): Abdominal discomfort, abdominal pain upper, gastroenteritis, vomiting[Ref]

Dermatologic

Common (1% to 10%): Acne, impetigo, contact dermatitis[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infections[Ref]

Ocular

Uncommon (0.1% to 1%): Retinal detachment[Ref]

Metabolic

Common (1% to 10%): Lipid elevations[Ref]

Respiratory

Very common (10% or more): Nasopharyngitis (up to 13%)

Common (1% to 10%): Oropharyngeal pain

Uncommon (0.1% to 1%): Pneumonia[Ref]

Nervous system

Common (1% to 10%): Headache, dizziness[Ref]

Frequently asked questions

References

1. Product Information. Cibinqo (abrocitinib). Pfizer U.S. Pharmaceuticals Group. 2022.

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.

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