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

Understanding the side effects of Hyrimoz (adalimumab-adaz) before you start treatment helps you recognize warning signs early and know when to seek medical attention. Hyrimoz is an effective medication for serious inflammatory diseases — but as a TNF inhibitor that works by modifying your immune system, it carries real risks that every patient and caregiver should understand.

The Boxed Warning: What You Must Know First

Hyrimoz carries the FDA's most serious warning — a "Boxed Warning" (sometimes called a Black Box Warning) — for two categories of serious risks:

Serious infections: Hyrimoz lowers your immune system's ability to fight infections. Serious infections — including tuberculosis (TB), bacterial sepsis, invasive fungal infections (histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, pneumocystosis), and other opportunistic infections — have occurred in patients taking adalimumab products. Some of these infections have been fatal.

Malignancies: Lymphoma and other cancers, some fatal, have been reported in children, adolescents, and young adults treated with TNF blockers. A rare and often fatal type of T-cell lymphoma called hepatosplenic T-cell lymphoma (HSTCL) has been reported — primarily in young males with Crohn's disease or ulcerative colitis who were also taking azathioprine or 6-mercaptopurine.

Common Side Effects (More Than 10% of Patients)

These side effects occur in more than 10% of patients taking Hyrimoz. They are generally manageable and may improve over time:

Injection site reactions: Pain, redness, swelling, or itching at the injection site. These are the most commonly reported side effect. The high-concentration citrate-free formulation of Hyrimoz is associated with less injection site pain than older, citrate-containing formulations.

Upper respiratory tract infections: Common colds, sore throats, and similar infections occur more frequently on Hyrimoz. Most are mild and resolve on their own.

Sinusitis: Sinus congestion and infection are reported in over 10% of patients.

Headache: A common reported side effect, usually mild.

Rash: Various rashes can occur. Most are mild, but report any rash to your doctor to rule out serious allergic reactions.

Serious Side Effects — Call Your Doctor Right Away

Contact your doctor immediately if you experience any of the following:

Signs of infection: Fever, chills, cough (that won't go away), shortness of breath, muscle aches, weight loss, warm/red/painful skin wounds, diarrhea/stomach pain, burning on urination, or feeling very tired

Signs of low blood cell counts: A fever that does not go away, easy bruising or bleeding, pale skin

Signs of serious allergic reaction (anaphylaxis — CALL 911): Hives, rash, swelling of face/eyes/lips/mouth, trouble breathing or swallowing, feeling faint or dizzy

Signs of liver problems: Yellowing of skin or eyes (jaundice), dark urine, stomach pain on the right side

Signs of nerve problems: Numbness/tingling/pain in arms or legs, vision changes, dizziness, weakness in the legs (could indicate demyelinating disease, including MS)

Signs of heart failure (new or worsening): Swelling of your ankles or feet, sudden weight gain, shortness of breath

Signs of lupus-like syndrome: Chest discomfort or pain that does not go away, shortness of breath, joint pain, rash on cheeks or arms that gets worse in the sun

Tuberculosis (TB) — A Special Risk to Know

Your doctor must test you for latent TB before starting Hyrimoz. If you have latent TB, it must be treated before starting Hyrimoz. Even if your TB test was negative before starting, watch for TB symptoms during treatment: persistent cough, coughing up blood, night sweats, fever, weight loss, or fatigue. TB can present in unusual ways (outside the lungs) in patients on immune-suppressing medications.

Hepatitis B Reactivation

If you are a chronic carrier of hepatitis B virus (HBV), Hyrimoz can reactivate the virus, potentially causing serious liver damage. Your doctor will screen you for HBV before starting treatment and will monitor you closely during and for several months after therapy. Tell your doctor if you have ever had hepatitis B.

Managing Injection Site Reactions

Injection site reactions are the most common side effect but are usually manageable. Tips to reduce discomfort:

Allow the medication to come to room temperature (30 minutes out of the refrigerator) before injecting

Rotate injection sites between abdomen and thigh (at least 1 inch from the previous site)

Apply a cold pack to the injection site before and after injecting

The high-concentration citrate-free Hyrimoz formulation (100 mg/mL) tends to cause less injection site pain than the older low-concentration citrate-containing formulation

For information on medications that interact with Hyrimoz and increase your risk of side effects, see our guide: Hyrimoz Drug Interactions: What to Avoid and What to Tell Your Doctor.

If side effect concerns are affecting your ability to stay on treatment, and you're having trouble filling your prescription, medfinder can help you quickly locate a pharmacy with Hyrimoz in stock.