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.

Summary

Common side effects include:

headache is a common Stelera side effect. Below is a complete list of side effects.

Consumer Relations

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.

Patients suffering from ulcerative colitis, nasopharyngitis abdominal pain, headaches and fever. sinusitis, diarrhea, fatigue nausea and vomiting in maintenance treatment.¶

How to manage adverse negative effects (general information)

For Healthcare Professionals

Ustekinumab is a Subcutaneous solution, intravenous solution

Respiratory

The most common (1 to 10% Nasopharyngitis and upper respiratory tract infections and oropharyngeal pain

Uncommon (0.1 to 1 %) Congestion of the nose ¶

Nervous system

Common (1% to 10%): Headache, dizziness

Non-common (0.1 percent to 1.1%) Facial palsy

Other

Common (1% to 10%): Fatigue

Gastrointestinal

The most common (1 -10%) Diarrhea, vomiting

Musculoskeletal

The most common (1 10% ) back pain, myalgia and arthralgia, chest pain

Local

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)

Dermatologic

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

Psychiatric

Common (1% to 10%): Depression

Oncologic

Common (1% to 10%): Malignancies (1.7%)

Reports on postmarketing Rapidly appearing multiple skin Squamous Cell Carcinomas

Hypersensitivity

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)

Immunologic

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.

	Placebo	STELARA®
	Placebo	45 mg	90 mg
Subjects treated	665	664	666
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).

More details

Always consult your doctor to confirm that the information provided on this site is appropriate to your particular situation.

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