Ustekinumab Side Effects
Some side effects of ustekinumab 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: 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;
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 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 side effects including headache (5%) and dizziness (2%) have been reported.
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 side effects including fatigue (3%) have been reported.
Gastrointestinal side effects including diarrhea (2%) have been reported.
Musculoskeletal side effects including back pain (up to 2%) and myalgia (1%) have been reported.
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 side effects including pruritus (up to 2%) have been reported.
Psychiatric side effects have included depression (1%).
In the controlled and non-controlled portions of psoriasis clinical trials 1.3% of ustekinumab 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 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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