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Stelara Side Effects

Generic Name: ustekinumab

Note: This page contains side effects data for the generic drug ustekinumab. It is possible that some of the dosage forms included below may not apply to the brand name Stelara.

For the Consumer

Applies to ustekinumab: subcutaneous solution

As well as its needed effects, ustekinumab (the active ingredient contained in Stelara) may cause unwanted side effects that require medical attention.

Major Side Effects

If any of the following side effects occur while taking ustekinumab, check with your doctor immediately:

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
Rare
  • 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

Minor Side Effects

Some ustekinumab side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned 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

Common (1% to 10%): Nasopharyngitis, upper respiratory tract infection, oropharyngeal pain
Uncommon (0.1% to 1%): Nasal congestion[Ref]

Nervous system

Common (1% to 10%): Headache, dizziness
Uncommon (0.1% to 1%): Facial palsy[Ref]

Other

Common (1% to 10%): Fatigue[Ref]

Gastrointestinal

Common (1% to 10%): Diarrhea, nausea[Ref]

Musculoskeletal

Common (1% to 10%): Back pain, myalgia, arthralgia[Ref]

Local

Common (1% to 10%): Injection site erythema, pain, bruising, irritation
Uncommon (0.1% to 1%): Injection site reactions (including hemorrhage, hematoma, induration, swelling, and pruritus)[Ref]

Dermatologic

Common (1% to 10%): Pruritus
Uncommon (0.1% to 1%): Pustular psoriasis, skin exfoliation
Rare (less than 0.1%): Exfoliative dermatitis
Postmarketing reports: Erythrodermic psoriasis[Ref]

Psychiatric

Common (1% to 10%): Depression[Ref]

Oncologic

Common (1% to 10%): Malignancies (1.7%)
Postmarketing reports: Rapidly appearing, multiple cutaneous squamous cell carcinomas[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Hypersensitivity reactions (including rash, urticaria)
Rare (less than 0.1%): Serious hypersensitivity reactions (including anaphylaxis and angioedema)[Ref]

Immunologic

Very common (10% or more): Infections (up to 27%)
Common (1% to 10%): About 6% of patients developed antibodies to this drug, dental infections
Uncommon (0.1% to 1%): Cellulitis, herpes zoster, viral upper respiratory tract infection[Ref]

References

1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

2. Cerner Multum, Inc. "Australian Product Information." O 0

3. "Product Information. Stelara (ustekinumab)." Centocor Inc, Malvern, PA.

It is possible that some side effects of Stelara may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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