Xeljanz Side Effects

Generic name: tofacitinib

Note: This document contains side effect information about tofacitinib. Some of the dosage forms listed on this page may not apply to the brand name Xeljanz.

Some side effects of Xeljanz may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to tofacitinib: oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking tofacitinib (the active ingredient contained in Xeljanz) hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Serious and sometimes fatal infections may occur during treatment with tofacitinib. Stop using this medicine and call your doctor right away if you have signs of infection such as:

• fever, chills, tired feeling, night sweats;

• stomach pain, loss of appetite, diarrhea, weight loss, or a change in your bowel habits;

• pain or burning when you urinate;

• body aches, sore throat, flu symptoms, sores in your mouth and throat;

• stabbing chest pain, wheezing, feeling short of breath, cough with mucus or blood; or

• skin redness and swelling.

Tofacitinib may also cause severe liver symptoms. Call your doctor at once if you have any of these liver symptoms:

• low fever, itching;

• upper stomach pain, loss of appetite;

• dark urine, clay-colored stools; or

• jaundice (yellowing of the skin or eyes).

Common side effects may include:

• headache; or

• mild cold symptoms such as runny or stuffy nose.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to tofacitinib: oral tablet

General

The most common serious adverse reactions were serious infections.

Cardiovascular

Common (1% to 10%): Hypertension

Dermatologic

Frequency not reported: Rash, erythema, pruritus

Gastrointestinal

Common (1% to 10%): Diarrhea
Frequency not reported: Abdominal pain, dyspepsia, vomiting, gastritis, nausea

Hematologic

Frequency not reported: Anemia, neutropenia, lymphopenia

Hepatic

Common (1% to 10%): AST elevation, ALT elevation
Frequency not reported: Hepatic steatosis, elevated bilirubin

Immunologic

Very common (10% or more): Overall infections (up to 22%)
Frequency not reported: Serious infection (most commonly pneumonia, cellulitis, herpes zoster and urinary tract infection), other non-TB opportunistic infection

Metabolic

Frequency not reported: Dehydration, increased total cholesterol, increased LDL cholesterol, increased HDL cholesterol, increased triglycerides

Musculoskeletal

Frequency not reported: Musculoskeletal pain, arthralgia, tendonitis, joint swelling

Nervous system

Common (1% to 10%): Headache
Frequency not reported: Paresthesia

Oncologic

Frequency not reported: Lung cancer, breast cancer, gastric cancer, colorectal cancer, renal cell cancer, prostate cancer, lymphoma, malignant melanoma, non-melanoma skin cancer

Other

Frequency not reported: Pyrexia, fatigue, peripheral edema

Psychiatric

Frequency not reported: Insomnia

Renal

Common (1% to 10%): Increased serum creatinine

Respiratory

Common (1% to 10%): Nasopharyngitis, upper respiratory tract infection
Frequency not reported: Dyspnea, cough, sinus congestion, tuberculosis (TB)

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