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: subcutaneous solution

Along with its needed effects, ustekinumab 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 ustekinumab:

More common
  • Cough or hoarseness
  • fever or chills
  • lower back or side pain
  • painful or difficult urination
Less common
  • Body aches or pain
  • difficulty with breathing
  • ear congestion
  • headache
  • loss of voice
  • nasal congestion
  • runny nose
  • sneezing
  • sore throat
  • unusual tiredness or weakness
  • Blurred or loss of vision
  • clear or bloody discharge from the nipple
  • confusion
  • difficult or frequent urination
  • dimpling of the breast skin
  • disturbed color perception
  • double vision
  • halos around lights
  • inverted nipple
  • itching, pain, redness, swelling, tenderness, or warmth on the skin
  • lump in the breast or under the arm
  • night blindness
  • overbright appearance of lights
  • persistent crusting or scaling of the nipple
  • redness or swelling of the breast
  • seizures
  • sore on the skin of the breast that does not heal
  • tunnel vision
Incidence not known
  • Difficulty with swallowing
  • dizziness
  • fast heartbeat
  • hives or welts
  • itching
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • rash
  • redness of the skin
  • tightness in the chest

Some side effects of ustekinumab 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
  • Muscle aches
Less common
  • Back pain
  • bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
  • depression
  • diarrhea
  • difficulty with moving
  • joint pain
  • muscle cramps
  • muscle pain or stiffness
  • swollen joints

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

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, 72.3% of ustekinumab-treated subjects reported infections. Serious infections were reported in 2.8% 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. Postmarketing reports have included pustular and erythrodermic psoriasis.


Psychiatric side effects have included depression (1%).


In the controlled and non-controlled portions of psoriasis clinical trials 1.7% of ustekinumab treated subjects reported malignancies (excluding non-melanoma skin cancers). Other than non-melanoma skin cancers (1.5%), the most frequently observed malignancies were prostate, colorectal, melanoma in situ, and breast.

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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