Skyrizi Side Effects: What to Expect and When to Call Your Doctor

Like all biologic medications, Skyrizi (risankizumab) can cause side effects. Most people tolerate Skyrizi well—clinical trial data show it has a favorable safety profile compared to many older biologics. But there are specific side effects to watch for, and some require prompt medical attention. Here's a plain-English guide to what to expect when you start Skyrizi.

How Safe Is Skyrizi? An Overview

Skyrizi does not have a boxed warning (Black Box Warning) from the FDA—the most serious type of safety alert. This distinguishes it from some other biologic classes. However, it does have important Warnings and Precautions related to infections, hypersensitivity reactions, and liver effects (in IBD patients). Clinical trials across multiple indications have generally shown low rates of serious adverse events.

Common Side Effects of Skyrizi

These side effects occur in a notable portion of Skyrizi patients, particularly during the induction phase. They are generally manageable and often resolve on their own:

Upper respiratory infections (URIs): The most frequently reported side effect—includes common cold, sinus infections, and pharyngitis. These are more common during induction. Most are mild and self-limited.

Headache: Reported particularly during induction doses. Usually mild.

Arthralgia (joint pain): Reported during both induction and maintenance. Contact your doctor if joint pain worsens significantly.

Injection site reactions: Bruising, redness, pain, itching, swelling, or warmth at the injection site. Usually mild and resolve quickly. Using proper injection technique (rotating sites, allowing the pen to reach room temperature before injecting) minimizes these.

Tinea infections: Fungal skin infections such as ringworm, athlete's foot, and jock itch. These are more common with Skyrizi than with some other biologics. Contact your doctor for antifungal treatment if symptoms appear.

Fever and fatigue: Reported during maintenance treatment in some patients (especially in IBD patients). Mild fever or fatigue shortly after injection is generally not a concern but should be mentioned to your doctor.

Serious Side Effects: Call Your Doctor Right Away

These side effects are less common but require prompt medical attention:

Serious infections: Skyrizi suppresses part of your immune system. Serious infections—including bacterial, viral, and fungal infections—can occur. Seek immediate medical care if you have high fever, chills, persistent cough, shortness of breath, burning with urination, or signs of a skin infection that is spreading.

Tuberculosis (TB) reactivation: TB screening is required before starting Skyrizi for this reason. Symptoms of active TB include: persistent cough lasting 3+ weeks, coughing up blood, night sweats, unexplained weight loss, and fatigue. Contact your doctor immediately if these occur.

Serious allergic reactions (anaphylaxis): Rarely, Skyrizi can cause severe allergic reactions including anaphylaxis. Call 911 immediately if you experience sudden swelling of the face, lips, tongue, or throat; difficulty breathing; chest tightness; severe hives; fainting or dizziness.

Liver toxicity (IBD patients): Drug-induced liver injury has been reported in patients receiving Skyrizi for Crohn's disease and ulcerative colitis. Call your doctor if you develop yellowing of the skin or eyes (jaundice), dark urine, severe fatigue, or upper right abdominal pain. Your doctor will monitor your liver enzymes during induction.

Important Safety Precautions While on Skyrizi

Vaccines: Avoid live vaccines while taking Skyrizi (e.g., live shingles vaccine Zostavax, live flu mist, yellow fever vaccine). Inactivated/non-live vaccines (like standard flu shots, pneumococcal vaccine, and shingles Shingrix) are acceptable. Complete all age-appropriate vaccinations before starting Skyrizi if possible.

Pregnancy: Limited data exist on Skyrizi use in pregnancy. Discuss with your doctor if you are pregnant or planning to become pregnant. The Skyrizi GLOW Pregnancy Registry (1-877-302-2161 or glowpregnancyregistry.com) monitors pregnancy outcomes.

Other immunosuppressants: Combining Skyrizi with other immunosuppressant drugs increases infection risk. Notably, Skyrizi is contraindicated with upadacitinib (Rinvoq).

Managing Side Effects Day to Day

For most patients, Skyrizi is well-tolerated and dramatically improves quality of life with relatively few side effect interruptions. If you experience side effects that concern you—even if they seem minor—report them to your prescribing specialist. Never stop Skyrizi without talking to your doctor first, as stopping and restarting biologics can affect their effectiveness. See our guide on Skyrizi Drug Interactions for information on medications and vaccines to avoid while on Skyrizi.