Stelara Side Effects

Generic name: ustekinumab

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

Some side effects of Stelara 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 ustekinumab: injectable injection

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

Serious infections may occur during treatment with ustekinumab. Call your doctor right away if you have signs of infection such as: fever, chills, muscle pain, shortness of breath, weight loss, diarrhea or stomach pain, burning when you urinate, feeling very tired, skin warmth or redness, painful skin sores, or coughing up blood.

Also call your doctor at once if you have:

• swelling, pain, tenderness, or redness anywhere on your body;

• stomach pain that is sudden and severe or comes on slowly, changes in bowel habits (diarrhea or constipation);

• stabbing chest pain, wheezing, cough with yellow or green mucus;

• blood in your urine; or

• severe headache, confusion, change in mental status, vision problems, and/or seizure (convulsions).

Common side effects may include:

• cold symptoms such as stuffy nose, sneezing, sore throat;

• headache; or

• mild tiredness.

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 ustekinumab: subcutaneous solution

Respiratory

Respiratory side effects including nasopharyngitis (up to 8%), upper respiratory tract infection (up to 5%), and pharyngolaryngeal pain (up to 2%) have been reported.

Nervous system

Nervous system side effects including headache (5%) and dizziness (2%) have been reported.

Other

Other side effects including cellulitis and other infections have been reported.

In the placebo-controlled period of clinical studies of psoriasis subjects, 27% of ustekinumab-treated subjects reported infections compared with 24% of placebo-treated subjects. Serious infections occurred in 0.3% of ustekinumab-treated subjects and in 0.4% of placebo-treated subjects.

In the controlled and non-controlled portions of psoriasis clinical trials, 61% of ustekinumab-treated subjects reported infections. Serious infections were reported in 0.9% of subjects.

General

General side effects including fatigue (3%) have been reported.

Gastrointestinal

Gastrointestinal side effects including diarrhea (2%) have been reported.

Musculoskeletal

Musculoskeletal side effects including back pain (up to 2%) and myalgia (1%) have been reported.

Local

Local side effects including injection site erythema (up to 2%) and other injection site reactions (pain, swelling, pruritus, induration, hemorrhage, bruising, and irritation) have been reported.

Dermatologic

Dermatologic side effects including pruritus (up to 2%) have been reported.

Psychiatric

Psychiatric side effects have included depression (1%).

Oncologic

In the controlled and non-controlled portions of psoriasis clinical trials 1.3% of ustekinumab (the active ingredient contained in Stelara) treated subjects reported malignancies (excluding non-melanoma skin cancers). Other than non-melanoma skin cancers, the most frequently observed malignancies were prostate, colorectal, melanoma in situ, and breast.

Non-melanoma skin cancer was reported in 1.3% of ustekinumab treated subjects.

Oncologic side effects including malignancies and postmarketing reports of rapidly appearing, multiple cutaneous squamous cell carcinoma have been reported.

Hypersensitivity

Hypersensitivity side effects have included postmarketing reports of serious hypersensitivity reactions (including anaphylaxis and angioedema, and other hypersensitivity reactions (including rash and urticaria).

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