Stelara Side Effects
Generic name: ustekinumab
Medically evaluated by MDtodate.com
NOTES: This document contains information on the side effects of ustekinumab. Certain of the dosage forms here might not be applicable to the Stelara brand name.
Infections that are serious can occur in the course of treatment with Stelara. Consult your physician right now if you are showing symptoms of infection, such as fever, chills muscles or shortness of breath. loss of weight, diarrhea or abdominal pain or burning after you urinate, feeling extremely fatigued, skin heat or redness, pain in the skin sores or a coughing up of blood.
Common side effects include:
- headache is a common Stelera side effect. Below is a complete list of side effects.
Applies to ustekinumab: parenteral injection, parenteral injection concentrate
Stelara Side Effects:
Patients suffering from psoriasis: Nasopharyngitis, upper respiratory tract illness as well as fatigue, headache and headache.
Patients with psoriatic arthritis Acute and negative effects that are similar to those experienced by patients suffering from psoriasis.
Patients suffering from Crohn’s disease experience vomiting during treatment induction; nasopharyngitis; injection site erythema, vulvovaginal candidiasis/ inflammation, bronchitis, urinary tract infection, pruritus sinusitis while on maintenance treatment.
How to manage adverse negative effects (general information)
For Healthcare Professionals
Ustekinumab is a Subcutaneous solution, intravenous solution
The most common (1 to 10% Nasopharyngitis and upper respiratory tract infections and oropharyngeal pain
Uncommon (0.1 to 1 %) Congestion of the nose ¶
Common (1% to 10%): Headache, dizziness
Non-common (0.1 percent to 1.1%) Facial palsy
Common (1% to 10%): Fatigue
The most common (1 -10%) Diarrhea, vomiting
The most common (1 10% ) back pain, myalgia and arthralgia, chest pain
Common (1% to 10%): Injection site erythema, pain, bruising, irritation
Rare (0.1 to 1 %) Reactions at the injection site (including hemorrhage and hematoma, swelling, induration, as well as inflammation)
Common (1% to 10%): Pruritus
Uncommon (0.1% to 1%): Pustular psoriasis, skin exfoliation
Seldom (less than 0.1 %) Exfoliative dermatitis
Marketing reports after the postmarketing period: Erythrodermic psoriasis
Common (1% to 10%): Depression
Common (1% to 10%): Malignancies (1.7%)
Reports on postmarketing Rapidly appearing multiple skin Squamous Cell Carcinomas
Uncommon (0.1 percent to 1.1%) Hypersensitivity reactions (including Urticaria, rash)
Seldom (less tthan <1%) hypersensitivity reactions serious (including anaphylaxis as well as angioedema)
Very frequent (10 10% or more) Diseases (up to 27 %)
The most common (1 -10%) approximately 6 % of patients develop antibodies to this medication, dental infections
Common (0.1 to 0.1% to) Herpes Zoster, viral upper respiratory tract infections
Clinical Trials Experience
Since the clinical trials take place under different conditions, the rate of adverse reactions found in clinical trials of a particular drug can’t be directly compared with rates observed in clinical trials of a different drug.
Adult Subjects With Plaque Psoriasis
The safety data are based on the exposure of STELARA(r) at 3117 subjects with psoriasis in adulthood which includes 2414 who were exposed for at least six months 1855 exposed for at most one year 1653 exposed for a minimum of two years 1569 exposed for at most three years 1482 exposed for at most four years, and 838 exposed for a minimum of five years.
The table lists all adverse reactions which were observed in a frequency of at less than 1%, as well as at a greater frequency within STELARA(r) STELARA(r) categories than in the placebo group during the placebo-controlled time for Ps STUDY1. Ps STUDY 2, [Ref].
Table: Negative Reactions Reported by >1 Percent of Subjects during Week 12 of Ps STUDY 1, and Ps STUDY 2.
|45 mg||90 mg|
|Nasopharyngitis||51 (8%)||56 (8%)||49 (7%)|
|Upper respiratory tract infection||30 (5%)||36 (5%)||28 (4%)|
|Headache||23 (3%)||33 (5%)||32 (5%)|
|Fatigue||14 (2%)||18 (3%)||17 (3%)|
|Diarrhea||12 (2%)||13 (2%)||13 (2%)|
|Back pain||8 (1%)||9 (1%)||14 (2%)|
|Dizziness||8 (1%)||8 (1%)||14 (2%)|
|Pharyngolaryngeal pain||7 (1%)||9 (1%)||12 (2%)|
|Pruritus||9 (1%)||10 (2%)||9 (1%)|
|Injection site erythema||3 (<1%)||6 (1%)||13 (2%)|
|Myalgia||4 (1%)||7 (1%)||8 (1%)|
|Depression||3 (<1%)||8 (1%)||4 (1%)|
The adverse reactions that were observed at a rate of less than percent in the control timeframe of the Ps STUDIES 1 & 2 up to week 12 were cellulitis, herpes zoster as well as certain reactions at the injection site (pain and swelling, pruritus bleeding, induration, inflammation, and bruising).
Always consult your doctor to confirm that the information provided on this site is appropriate to your particular situation.