From the Guidelines
Approximately 0.9% of patients experience opportunistic infections with Humira (adalimumab), and the overall risk of negative side effects is relatively low. The most common side effects associated with anti-TNF therapies, including Humira, are opportunistic infections, which occur in about 0.9% of patients, compared to 0.3% of patients receiving placebo 1. More serious but less common side effects include serious infections, allergic reactions, nervous system problems, blood disorders, heart failure, and rarely, certain types of cancer.
Key Side Effects
- Opportunistic infections, such as Mycobacterium tuberculosis, herpes simplex infection, oral or esophageal candidiasis, herpes zoster infection, varicella-zoster virus infection, cytomegalovirus or Epstein–Barr virus infection, and Nocardia infection, occur in about 0.9% of patients 1
- Malignancies, including lymphoma, are not significantly increased with anti-TNF therapy, with a reported rate of 0.39% in patients receiving anti-TNF therapies compared to 0.45% in patients receiving placebo 1
Important Considerations
- The risk of developing tuberculosis is increased in patients taking Humira, which is why TB screening is required before starting treatment 1
- Side effect risk varies based on individual factors such as age, overall health, and concurrent medications
- Regular monitoring by a healthcare provider is essential to identify and manage any potential problems early
- The evidence grading is higher for golimumab, but the consensus group determined that there was no evidence to suggest clinical differences among the agents, and therapy should continue with the agent used to induce remission 1
From the FDA Drug Label
ADVERSE REACTIONS Most common adverse reactions (>10%) are: infections (e.g. upper respiratory, sinusitis), injection site reactions, headache and rash. (6.1) The FDA drug label does not provide a specific percentage of patients who experience problems or negative side effects with Humira. However, it does list the most common adverse reactions, which include infections, injection site reactions, headache, and rash, occurring in more than 10% of patients.
- Common adverse reactions include:
- Infections (e.g. upper respiratory, sinusitis)
- Injection site reactions
- Headache
- Rash It is also mentioned that serious adverse reactions can occur, such as serious infections, malignancies, anaphylaxis or serious hypersensitivity reactions, hepatitis B virus reactivation, demyelinating disease, cytopenias, pancytopenia, heart failure, and lupus-like syndrome 2.
From the Research
Adalimumab Side Effects
- The most common side effects of adalimumab are injection site reactions 3
- Adalimumab increases the risk of rare serious infections, with a two-fold risk of serious infections as reported in the Premier trial 3
- Other side effects include:
- Skin rashes 3
- Worsening or initiation of congestive heart failure 3
- Lupus-like syndrome 3
- Promotion of lymphoma 3
- Medically significant cytopenias 3
- Worsening or initiation of a multiple sclerosis/neurological disease 3, 4, 5
- Pancytopenia and elevated transamines 3
- Central Nervous System (CNS) demyelination 4, 5
Incidence of Adverse Drug Reactions
- The incidence of adverse drug reactions was 16.2% in a study of hospitalized patients 6
- For each medication introduced during hospitalization, there was a 10% increase in the rate of adverse drug reaction 6
- However, the specific percentage of patients who experience problems or negative side effects with Humira (adalimumab) is not directly stated in the provided studies