In the US, autoimmune diseases affect approximately 50 million individuals, ranking as the third most prevalent disease category after cancer and heart disease. Among the medications used in managing these conditions, Humira stands out as one of the top-selling drugs globally, with peak sales of $21.2 billion in 2022.

Humira, whose generic name is adalimumab, belongs to a class of medications known as tumor necrosis factor (TNF) inhibitors. It’s indicated for various autoimmune diseases, including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa, and uveitis.

The mechanism of action of TNF inhibitors such as Humira involves targeting and inhibiting the activity of TNF-alpha, a key protein involved in inflammatory processes. By doing so, these drugs effectively mitigate inflammation and relieve symptoms associated with autoimmune disorders.

Despite its therapeutic efficacy, Humira is not without its share of side effects that demand careful consideration. In this article, we aim to comprehensively examine the side effects of Humira to help patients make informed decisions, safeguard their well-being, and take an active role in their healthcare.

Key Findings

  • Reactivation of latent viral infections, such as varicella-zoster virus (causing shingles) and cytomegalovirus, is possible with Humira treatment.
  • Humira has been linked to an increased risk of certain cancers, including lymphoma and non-melanoma skin cancer, particularly in patients with specific conditions or demographics.
  • Hepatitis B virus (HBV) reactivation can occur in individuals receiving Humira, potentially leading to severe liver complications.
  • Neurological reactions, hematological reactions, heart failure, autoimmunity, and liver and gallbladder complications are among the other serious side effects associated with Humira.

What are the Side Effects of Humira?

Like any medication, Humira can have side effects, although not everyone will experience them. Below is the range of potential side effects associated with its use.

Common Side Effects of Humira

The following is a comprehensive list of Humira’s common side effects based on data from four placebo-controlled trials.

  • Upper respiratory infection
  • Sinusitis
  • Flu syndrome
  • Nausea
  • Abdominal pain
  • Headache
  • Rash
  • Accidental injury
  • Injection site reaction
  • Back pain
  • Urinary tract infection
  • Hypertension

Serious Side Effects of Humira

Doctor speaking with senior patient

Serious side effects of Humira (adalimumab) are rare but can occur. It’s important to be aware of these potential risks and to report any concerning symptoms to your healthcare provider promptly. These side effects can include:

1. Serious Infections

Patients receiving treatment with Humira face an elevated risk of developing severe infections affecting various organ systems and sites, potentially resulting in hospitalization or death. Infections that have been reported with the use of TNF blockers include:

  • Aspergillosis: A fungal infection resulting from exposure to the Aspergillus fungus, a prevalent mold found both indoors and outdoors. Potential complications include allergic responses, respiratory infections (pulmonary aspergillosis), and infections in other bodily organs. Common symptoms may include shortness of breath, cough, fever, and fatigue.
  • Blastomycosis: An infection caused by Blastomyces dermatitidis, a fungus commonly found in moist soil, decaying organic matter, and wooded areas, particularly around bodies of water. Symptoms may include fever, cough, muscle aches, and skin lesions.
  • Candidiasis: An infection caused by various species of Candida yeast, including Candida albicans. Candida organisms are common in the environment and are part of the body’s normal flora. However, the overgrowth of Candida, often due to factors like weakened immunity or antibiotic use, can lead to infections. Candidiasis can affect various parts of the body, causing symptoms such as itching, redness, and discharge.

Soil-disturbing activities like construction can release fungal spores into the air, potentially causing infection. Lung symptoms include cough and chest pain, while spread beyond the lungs can manifest as joint pain, neck stiffness, and headaches.

  • Histoplasmosis: An infection caused by inhaling spores of the fungus Histoplasma capsulatum, commonly found in soil enriched with bird or bat droppings. Histoplasma species thrive in humid environments with high nitrogen content, both indoors and outdoors. Symptoms include fever, chills, headache, muscle aches, dry cough, and chest discomfort.
  • Legionellosis: An infection caused by Legionella bacteria, primarily Legionella pneumophila, commonly found in water sources such as lakes, rivers, and plumbing systems. Inhalation or aspiration of contaminated water droplets, particularly in aerosolized form, can result in Legionellosis, leading to severe pneumonia (Legionnaires’ disease) or a milder flu-like illness (Pontiac fever).
  • Listeriosis: An infection caused by the bacterium Listeria monocytogenes, commonly found in soil, water, and various foods. Listeria bacteria can survive and grow in various conditions, including both indoor and outdoor environments.

The primary route of transmission is the consumption of contaminated food, particularly unpasteurized dairy products, raw vegetables, deli meats, and soft cheeses. Listeriosis can cause flu-like symptoms, meningitis, or bloodstream infections, particularly in vulnerable populations.

  • Pneumocystosis: Also known as Pneumocystis pneumonia (PCP), is an infection caused by the yeast-like fungus Pneumocystis jirovecii. Pneumocystis species are opportunistic pathogens commonly found in indoor and outdoor environments, particularly in dust, soil, and air. PCP primarily affects individuals with weakened immune systems and can cause severe pneumonia and respiratory failure if left untreated.
  • Tuberculosis (TB): An infection caused by the bacterium Mycobacterium tuberculosis, commonly found in the environment. TB transmission typically occurs indoors, particularly in crowded or poorly ventilated spaces.

Inhaling bacteria-containing droplets released into the air when an infected person coughs or sneezes can lead to TB infection. TB primarily affects the lungs but can also involve other organs, causing symptoms such as cough, fever, weight loss, and fatigue.

Tuberculosis cases, in particular, have been observed in patients treated with Humira, including those with previous tuberculosis treatment.

In a comprehensive analysis of 52 clinical trials conducted globally, the reported active tuberculosis incidence rate was 0.20 per 100 patient-years. This means that for every 100 patients treated with Humira for one year, approximately 0.20 of them developed active tuberculosis during that time.

The incidence rate of positive purified protein derivative (PPD) conversion is 0.09 per 100 patient-years. PPD conversion is an indicator of exposure to tuberculosis bacteria.

2. Latent Viral Infections

Studies suggest an association between TNF-alpha inhibitors and an increased risk of viral infections, particularly the reactivation of varicella zoster virus (VZV) and cytomegalovirus (CMV).

VZV infection in children leads to chickenpox, which can later become latent and reactivated in adults, causing herpes zoster (shingles). Shingles usually present as a painful rash with blisters, often occurring in a single stripe or band on one side of the body, along a nerve pathway.

CMV is a common virus belonging to the herpesvirus family. It can infect people of all ages and is typically harmless to healthy individuals. However, CMV can cause serious health problems in people with weakened immune systems.

Research on patients with rheumatoid arthritis (RA) found that TNF-alpha inhibitors like infliximab and adalimumab (Humira) may significantly increase the risk of herpes zoster. However, recent studies have found conflicting results. Given the mixed evidence, it’s important to exercise caution regarding the potential elevated risk of herpes zoster.

3. Increased Risk of Certain Cancers 

Humira has been associated with specific types of cancers, notably lymphoma, which affects the lymphatic system, and non-melanoma skin cancer. Additionally, observed malignancies include breast, colon, prostate, lung, and melanoma.

Patients with certain conditions, such as chronic obstructive pulmonary disease (COPD) with a significant smoking history and those treated with cyclophosphamide for Wegener’s granulomatosis, have shown a higher risk of malignancies.

Furthermore, reports of malignancies, some of which were fatal, have emerged among children, adolescents, and young adults treated with TNF-blockers. Approximately half of these cases were lymphomas, including Hodgkin’s and non-Hodgkin’s.

The remaining cases included a variety of other malignancies, including rare ones typically associated with immunosuppression, as well as those uncommon in younger age groups. Humira presently carries a black box warning regarding its impact on cancer risk.

4. Hepatitis B Virus (HBV) Reactivation

HBV reactivation, sometimes fatal, has been reported in patients undergoing TNF blocker therapy, particularly when combined with other immune-suppressing medications. It is primarily transmitted through contact with infectious blood or body fluids of an infected person. Symptoms may involve:

  • muscle pain
  • extreme fatigue
  • darkened urine
  • yellowish skin or eyes
  • reduced appetite
  • nausea
  • pale bowel movements
  • fever
  • shivering
  • abdominal discomfort
  • skin eruption

5. Allergic Reactions

Anaphylaxis and angioneurotic edema have been documented after administering Humira. Throughout clinical trials, a range of allergic reactions, including allergic rash, anaphylactoid reaction, fixed drug reaction, unspecified drug reaction, and urticaria, were observed. Symptoms of a severe allergic response may include hives, difficulty breathing, and swelling of the face, eyes, lips, or mouth.

6. Neurologic Reactions

Humira and other TNF-blocking agents have been linked to rare occurrences of new onset or worsening clinical symptoms, along with radiographic signs, of central nervous system demyelinating diseases. These conditions involve damage to the protective covering of nerve fibers in either the central nervous system (comprising the brain and spinal cord) or the peripheral nervous system (comprising nerves outside the brain and spinal cord).

Neurological side effects of Humira include conditions like multiple sclerosis (MS), optic neuritis, and Guillain-Barré syndrome. While all three conditions can have serious consequences, Guillain-Barré syndrome is potentially life-threatening, especially if not promptly diagnosed and treated. It can lead to severe muscle weakness, paralysis, respiratory failure, and even death in some cases.

In a study involving 77 participants, three subjects developed neurological adverse events. Specifically, a 45-year-old woman with rheumatoid arthritis developed optic neuritis after 6 months of adalimumab (Humira) therapy. Overall, the estimated rate of neurological adverse events among patients receiving anti-TNF therapy was 4%.

Symptoms like numbness or tingling, vision changes, muscle weakness, or unexplained dizziness may indicate nervous system problems.

7. Hematological Reactions

Pancytopenia, which involves a significant reduction in all types of blood cells (red blood cells, white blood cells, and platelets), including aplastic anemia (a condition where the bone marrow fails to produce enough blood cells), has been reported in rare cases with TNF blockers.

While adverse reactions affecting the blood system, such as thrombocytopenia (low platelet count) and leukopenia (low white blood cell count), have infrequently been reported with Humira, the direct cause-and-effect relationship with the medication remains unclear. Symptoms include a fever that does not go away, bruising or bleeding easily, or looking very pale.

8. Heart Failure

Some cases have been reported where TNF blockers have either worsened pre-existing congestive heart failure (CHF) or led to new onset CHF. CHF is a condition where the heart is unable to pump blood effectively, leading to symptoms such as shortness of breath, fatigue, and fluid retention.

Humira has not undergone formal studies specifically focusing on patients with CHF. However, in clinical trials involving another TNF blocker, a higher rate of serious adverse reactions related to CHF was observed. Signs or symptoms of worsening CHF include increased shortness of breath, swelling of ankles or feet, fatigue, and sudden weight gain.

9. Autoimmunity

Treatment with Humira can lead to the production of autoantibodies, which are antibodies that mistakenly target the body’s own tissues. In controlled trials involving patients with rheumatoid arthritis, 12% of patients treated with Humira developed positive titers for antinuclear antibodies (ANA), a marker often elevated in autoimmune diseases like lupus.

In rare cases, this may result in the development of a lupus-like syndrome, which shares some similarities with systemic lupus erythematosus (SLE), commonly known as lupus. Symptoms of a lupus-like syndrome may include joint pain, skin rash, fever, and fatigue.

The long-term side effects of Humira treatment on the development of autoimmune diseases, including lupus-like syndrome, are uncertain and require further investigation.

10. Liver and Gallbladder Complications

Studies indicate that adalimumab, the active ingredient in Humira, can cause an increase in several liver enzymes, including aspartate aminotransferase (AST), alanine aminotransferase (ALT), and gamma-glutamyltransferase (GGT). Elevated levels of these enzymes often signify inflammation and damage to liver cells. In clinical trials involving different conditions treated with Humira, ALT levels that are three times or more above the upper limit of normal ranged from 0.3% to 4.4% in Humira-treated patients. 

Furthermore, Humira has been associated with the onset of cholecystitis, a painful inflammation of the gallbladder, as well as cholestasis, a condition characterized by reduced bile flow from the liver.

Symptoms indicating liver or gallbladder issues may include feeling tired, skin or eyes that look yellow (Jaundice), poor appetite or vomiting, and pain on the right side of your stomach (abdomen). These problems can lead to liver failure and death.

11. Psoriasis (New or Worsening)

TNF blockers have greatly improved treatments for diseases like psoriasis and psoriatic arthritis. Paradoxically, they can also cause or worsen skin problems like psoriatic skin lesions in about 0.6% to 5.3% of patients, mostly those with Crohn’s disease or rheumatoid arthritis.

Psoriasis can show up on the skin differently, like red patches with silvery scales or pus-filled bumps. Among these drugs, infliximab is most likely to cause skin issues, followed by etanercept, adalimumab (Humira), certolizumab pegol, and golimumab.

Others

Additional serious adverse reactions, occurring in less than 5% of Humira-treated patients in studies, include:

  • Pain in extremity
  • Pelvic pain
  • Surgery-related pain
  • Thorax pain
  • Arrhythmia
  • Atrial fibrillation
  • Chest pain
  • Coronary artery disorder
  • Heart arrest
  • Hypertensive encephalopathy
  • Myocardial infarct
  • Palpitation
  • Pericardial effusion
  • Pericarditis
  • Syncope
  • Tachycardia
  • Cholecystitis
  • Cholelithiasis
  • Esophagitis
  • Gastroenteritis
  • Gastrointestinal hemorrhage
  • Hepatic necrosis
  • Vomiting
  • Parathyroid disorder
  • Agranulocytosis
  • Polycythemia
  • Dehydration
  • Abnormal healing
  • Ketosis
  • Paraproteinemia
  • Peripheral edema
  • Arthritis
  • Bone disorder
  • Non-spontaneous bone fracture
  • Bone necrosis
  • Joint disorder
  • Muscle cramps
  • Myasthenia
  • Pyogenic arthritis
  • Synovitis
  • Tendon disorder
  • Adenoma
  • Confusion
  • Paresthesia
  • Subdural hematoma
  • Tremor
  • Asthma
  • Bronchospasm
  • Dyspnea
  • Decreased lung function
  • Pleural effusion
  • Cataract
  • Leg thrombosis
  • Cystitis
  • Kidney calculus
  • Menstrual disorder

These serious side effects highlight how vital it is for patients and healthcare providers to stay vigilant and communicate openly during Humira treatment. If any worrying symptoms arise, promptly reach out to a healthcare professional for further assessment and support.

How to Minimize Humira Side Effects

Female doctor examining senior male patient

Everyone’s experience with medication side effects can vary, so it’s important to communicate openly with your healthcare provider about any concerns or issues you may have. They can provide personalized advice and support to help you manage your symptoms effectively.

In the case of Humira treatment, there are general strategies that can be used to ease potential discomfort associated with its use. These may include:

1. Skin-related Side Effects

Managing the skin-related side effects of Humira (adalimumab) involves several strategies, but it’s essential to consult with your healthcare provider for personalized advice. Here are some general tips:

  • Moisturize: Keep your skin well moisturized to prevent dryness and irritation. Use fragrance-free moisturizers and apply them regularly, especially after bathing or showering.
  • Sun Protection: Use sunscreen with a high SPF to protect your skin from the sun. Humira can increase your sensitivity to sunlight, so wearing protective clothing and avoiding prolonged sun exposure is also important.
  • Avoid Irritants: Try to avoid harsh soaps, detergents, and skincare products that may irritate your skin. Opt for gentle, hypoallergenic products instead.
  • Cool Compresses: If you experience itching or irritation, applying cool compresses to the affected areas can help soothe the skin.
  • Stay Hydrated: Drink plenty of water to keep your skin hydrated from the inside out.

Look for any signs of infection, such as increased redness, swelling, or pus. If you notice any signs of infection, contact your healthcare provider immediately.

2. Injection Site Reaction

Humira’s most common side effect is injection site reactions, affecting about 37% of users. Here are tips to ease injection discomfort:

  • Rotate injection sites: Avoid using the same injection site repeatedly. Rotate the injection site with each dose to minimize discomfort and reduce site reactions.
  • Apply ice or heat: Applying ice or a cold pack to the injection site before and after injection can help reduce pain and inflammation. Some people find that applying heat after the injection can help alleviate discomfort.
  • Use proper injection technique: Ensure that you are using the correct technique for administering the injection. Follow the instructions provided by your healthcare provider or the medication’s packaging carefully. Proper technique can help minimize tissue damage and reduce the likelihood of injection site reactions.
  • Allow the medication to reach room temperature: Before injecting Humira, allow the medication to reach room temperature for about 15 to 30 minutes. This can help reduce both reactions and pain, as colder injections are more painful.
  • Massage the injection site: Gently massaging the injection site after administering the medication can help disperse the medication and reduce the risk of developing lumps or irritation at the injection site.
  • Keep the injection area clean: Before administering the injection, clean the injection site with an alcohol swab to reduce the risk of infection.

3. Abdominal Pain

Here are some general tips on managing abdominal pain:

  • Keep a food diary to track your diet and identify triggers for abdominal pain.
  • Avoid spicy, fatty, dairy (if lactose intolerant), and high-fiber foods if you have digestive conditions like IBS.
  • Choose smaller, more frequent meals throughout the day.
  • Manage stress with techniques like deep breathing, meditation, yoga, or regular exercise to reduce abdominal pain.
  • Use a heating pad or warm compress on your abdomen to relax muscles and ease discomfort.

If abdominal pain persists, contact your doctor immediately for evaluation and appropriate management.

4. Headache

Make sure you drink enough water during the day to stay hydrated, as dehydration can sometimes cause headaches. You can also try over-the-counter pain relievers, but talk to your healthcare provider first.

5. Upper Respiratory Tract Infections

Practice good hygiene habits, such as frequent handwashing with soap and water, to reduce your risk of contracting upper respiratory tract infections. Avoid close contact with individuals who are sick, and consider wearing a mask in crowded or high-risk settings.

6. Sinusitis

A general tip for managing sinusitis is to maintain good sinus hygiene. This includes regularly rinsing your nasal passages with saline solution to help clear mucus and reduce inflammation. Additionally, staying hydrated and using a humidifier can help keep nasal passages moist and facilitate drainage.

7. Urinary Tract Infection

Drink plenty of water to help flush out bacteria from the urinary tract. Additionally, practicing good hygiene, such as wiping from front to back after using the restroom and urinating after sexual intercourse, can help prevent the spread of bacteria.

Wrap-Up

Humira, while often effective in managing autoimmune disorders, can lead to various side effects, both common and rare. Among the most frequently reported side effects are injection site reactions, headaches, and skin rashes. These side effects are generally mild and manageable for most individuals.

However, there are also serious side effects associated with Humira. These include severe infections like tuberculosis and reactivation of the hepatitis B virus, along with an elevated susceptibility to cancer. While these side effects are uncommon, they require careful consideration and monitoring.

Despite the possibility of side effects, many individuals living with autoimmune disorders find that the benefits of Humira treatment outweigh the associated risks.

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Frequently Asked Questions

What are the worst side effects of Humira?

The worst side effects of Humira include serious infections, increased risk of lymphoma and other cancers, neurological problems, heart failure, hepatitis B reactivation in people who carry the virus, lupus-like syndrome, and blood disorders. Before starting Humira, have a thorough discussion with your healthcare provider first to understand the risks and benefits fully. 

What are the most common side effects of Humira?

In clinical trials, more than 10% of patients treated with Humira experienced common side effects, primarily infections such as upper respiratory infections and sinusitis, injection site reactions, headaches, and rashes. Fortunately, these side effects are typically mild and manageable.

Are there specific Humira side effects after the first dose?

It’s not guaranteed that side effects will occur at any specific stage of Humira treatment, such as after the first dose. However, there is a heightened likelihood of experiencing an allergic reaction following the initial dose of Humira compared to subsequent doses.

Are there any side effects if I miss a dose of Humira?

Missing a dose of Humira shouldn’t typically result in immediate side effects, but it’s essential to maintain a consistent dosing schedule as prescribed by your healthcare provider. If you realize you’ve missed a dose, contact your healthcare provider for guidance on what to do next. They may advise you to administer the missed dose immediately or adjust your dosing schedule accordingly. Avoid doubling doses unless your healthcare provider advises, as this could raise the risk of side effects.

How long does Humira stay in your system?

The rate at which individuals metabolize medication varies. In healthy adults, it typically takes around 12 weeks (3 months) for most of the adalimumab to exit the body.

Is Humira worth the risks?

You and your doctor will collaboratively determine if Humira is appropriate for your condition. Humira will only be prescribed if its potential benefits outweigh the risks of side effects.

Can you overdose on Humira?

The potential toxicity of adalimumab in cases of overdose or prolonged exposure isn’t well understood due to the absence of long-term studies. However, you should not take more than the prescribed dose as it can lead to serious side effects. In case of an overdose, immediate medical attention is necessary. Although accidental overdose is possible, reported cases of hepatotoxicity associated with adalimumab have been typically mild and self-limiting.

How often is Humira injected?

The dosing regimen for Humira varies according to the specific medical condition being treated. Some conditions require weekly dosing, while others necessitate dosing every other week.

Will humira cause weight gain?

Clinical studies of Humira did not report weight gain as a side effect. Nevertheless, weight gain has been associated with the use of other TNF blockers. Additionally, weight gain may be indicative of heart failure, another potential side effect of Humira.

Does Humira cause hair loss?

During the clinical trials for Humira, participants did not report hair loss (alopecia) as a side effect. However, after the FDA approved the drug, some individuals reported experiencing hair loss following its use.

How long until the side effects of Humira go away?

The duration can vary, but common side effects may be resolved within a few days to a couple of weeks.

What medications interact with Humira?

Medications that interact with Humira (adalimumab) include other TNF blockers like etanercept (Enbrel) and methotrexate, which is frequently used in rheumatoid arthritis management. Moreover, drugs that suppress the immune system, such as abatacept and anakinra, may also interact with Humira. Humira is also known to have interactions with over 480 medications, including commonly used ones like amlodipine, atorvastatin, and prednisone. It’s important to disclose all ongoing treatments and medications to your healthcare provider before initiating Humira to ensure safe and effective therapy.

Is fatigue a side effect of Humira?

Fatigue hasn’t been documented as a known side effect of Humira. However, experiencing tiredness could signal other adverse effects, such as an infection or liver issues.

Is Humira safe?

Overall, Humira has been found to be safe and effective. However, as with any medication, there are potential side effects and risks to consider.

Are there specific side effects of Humira for rheumatoid arthritis?

The side effects of Humira listed on its prescribing information were drawn from clinical trials primarily focused on rheumatoid arthritis. This is because findings from trials for other conditions reveal similar side effects occurring at comparable rates across both adult and pediatric patients. Therefore, the common side effects associated with Humira are also the specific side effects observed in its use for rheumatoid arthritis. These include upper respiratory infection, sinusitis, flu syndrome, nausea, abdominal pain, headache, rash, accidental injury, injection site reaction, back pain, urinary tract infection, and hypertension.

Can Humira cause withdrawal symptoms?

It’s unlikely to experience withdrawal symptoms upon discontinuing Humira. However, stopping the treatment may lead to a resurgence or worsening of your condition.

Can Humira cause anxiety?

Psychiatric manifestations in patients with autoimmune diseases can stem from various factors, including the disease itself, its treatment, and the psychosocial impact of managing a chronic illness. Humira effectively treats conditions such as inflammatory bowel disease (IBD) and rheumatoid arthritis, which are often associated with anxiety and depression. However, Humira itself is not known to directly cause anxiety.

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