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

What to Know About Hadlima Side Effects

Starting a new biologic medication like Hadlima (adalimumab-bwwd) comes with questions — and worrying about side effects is completely normal. The good news is that most people tolerate Hadlima well, and many side effects are mild and manageable. But because Hadlima affects your immune system, there are some serious risks you should understand before starting treatment.

This guide covers both the common and serious side effects of Hadlima based on FDA-approved labeling, so you know exactly what to watch for.

What Is Hadlima?

Hadlima is a biosimilar to Humira (adalimumab) made by Organon. It's a TNF blocker — a type of biologic that reduces inflammation by targeting a protein called tumor necrosis factor-alpha (TNF-alpha). It's used to treat autoimmune conditions like rheumatoid arthritis, Crohn's disease, ulcerative colitis, psoriasis, and several others.

Because Hadlima is a biosimilar, its safety profile is essentially the same as Humira's. The side effects listed here are based on clinical trials and post-marketing data for adalimumab products.

Common Side Effects

These side effects are reported frequently in clinical trials and are generally mild to moderate:

• Injection site reactions — Redness, pain, swelling, itching, or bruising where you inject. This is the most common side effect and usually improves after the first few injections.
• Upper respiratory infections — Cold-like symptoms including sore throat, stuffy nose, and sinus pressure
• Sinusitis — Sinus infections may occur more often while on Hadlima
• Headache — Usually mild and temporary
• Rash — Skin reactions that are typically not severe
• Nausea — Mild stomach discomfort, especially early in treatment
• Back pain — Reported in clinical trials at higher rates than placebo
• Urinary tract infections — More common due to immune suppression

Most of these side effects don't require you to stop treatment. If they're bothersome, talk to your doctor about management strategies.

Serious Side Effects

Hadlima carries a boxed warning — the most serious type of FDA warning — for two major risks:

Serious Infections

Because Hadlima suppresses part of your immune system, it increases your risk of serious infections. These can include:

• Tuberculosis (TB) — Including reactivation of latent TB. You must be tested before starting Hadlima.
• Bacterial sepsis — Bloodstream infections that can be life-threatening
• Invasive fungal infections — Including histoplasmosis and aspergillosis
• Opportunistic infections — Infections that take advantage of a weakened immune system

When to call your doctor: Contact your doctor immediately if you develop a fever, chills, persistent cough, night sweats, unexplained weight loss, or any signs of infection while taking Hadlima.

Malignancy Risk

TNF blockers have been associated with an increased risk of certain cancers:

• Lymphoma — Reported at higher rates in patients on TNF blockers than the general population
• Hepatosplenic T-cell lymphoma (HSTCL) — A rare but often fatal cancer reported mainly in adolescents and young adults taking TNF blockers with Azathioprine or 6-Mercaptopurine
• Other malignancies — Including skin cancers (melanoma and non-melanoma)

Other Serious Side Effects

• Hepatitis B reactivation — If you carry the hepatitis B virus, Hadlima can cause it to become active again. Testing is done before treatment starts.
• Anaphylaxis and severe allergic reactions — Rare but possible. Symptoms include difficulty breathing, swelling, and hives.
• Demyelinating diseases — New or worsening conditions affecting the nervous system, similar to multiple sclerosis
• Cytopenias — Abnormally low blood cell counts, including severe cases (pancytopenia)
• Heart failure — New onset or worsening of existing heart failure
• Lupus-like syndrome — Symptoms including joint pain, rash, and sensitivity to sunlight
• Autoimmune hepatitis — Liver inflammation caused by the immune system

Specific Populations

Pregnancy and Breastfeeding

Hadlima is not recommended during pregnancy because it may affect the immune response of the developing baby. If you become pregnant while taking Hadlima, contact your doctor right away. Hadlima is present in breast milk at low levels — discuss the risks and benefits with your doctor if you plan to breastfeed.

Children

Hadlima is approved for juvenile idiopathic arthritis in children 2 years and older and Crohn's disease in children 6 years and older. The boxed warning about malignancy is particularly important in pediatric patients.

Older Adults

Patients over 65 have a higher risk of infections while on Hadlima. Closer monitoring may be needed.

How to Manage Common Side Effects

Here are practical tips for dealing with the most frequent side effects:

• Injection site reactions: Let the medication reach room temperature before injecting. Use the citrate-free formulation (40 mg/0.4 mL) if available — it tends to sting less. Apply an ice pack before and after injection. Rotate injection sites between your thigh and abdomen.
• Upper respiratory infections: Practice good hand hygiene, avoid close contact with sick people, and stay up to date on recommended vaccines (but avoid live vaccines while on Hadlima).
• Headache and nausea: Usually resolve on their own. Over-the-counter remedies like Acetaminophen (Tylenol) can help with headaches — check with your doctor first.

For a fuller picture of how Hadlima works in your body, see our mechanism of action guide. And if cost is a concern, check our savings guide — because side effects are easier to manage when you can actually afford your medication.

Final Thoughts

Hadlima is an effective treatment for many autoimmune conditions, and most patients tolerate it well. The common side effects — injection site reactions, headaches, and minor infections — are manageable for most people. The serious risks, while real, are relatively rare and are monitored through regular check-ups and lab work.

The key is to stay informed and stay in contact with your doctor. Report any unusual symptoms promptly, keep up with your scheduled blood tests, and don't skip your TB screening. With the right monitoring, many people take Hadlima safely for years.

Looking for Hadlima near you? Check availability on Medfinder.