Humira Side Effects & Safety Review
The safety of Humira has been tested in 2,468 patients with RA who took part in controlled studies of the drug, 1,497 of whom were exposed to the drug for more than one year and had moderately to severely active RA. The most common side effects and adverse reactions included infections, nausea and abdominal pain, headache, rash, injection site reaction, back pain, hypertension, and selected laboratory abnormalities, including elevated cholesterol and lipids and increased alkaline phosphatase (an indication of decreased liver function).1
Most common side effects and adverse reactions with Humira1*
|Side effect||HUMIRA 40 mg every two weeks (N=705)||Placebo (N=690)|
|Upper respiratory infection||17%||13%|
|Alkaline phosphatase increased (liver function abnormality)||5%||3%|
|Injection site reaction**||8%||1%|
|Urinary tract infection||8%||5%|
|* Occuring in at least 5% of patients in Phase 3 clinical trials in RA.
**Does not include injection site erythema, itching, hemorrhage, pain or swelling.
Warnings and precautions with Humira
There are several warnings and precautions you should know about before you start treatment with Humira.
There is an increased risk for developing serious infections with Humira, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (fungal infection inside the body) such as histoplasmosis, coccidioidomycosis, or blastomycosis (people who live in the Ohio or Mississippi River Valleys are at increased risk for these types of infections), and other opportunistic infections (infections that result from microorganisms that normally do not cause diseases in humans). The increased risk of infection with Humira occurs because the drug can decrease the ability of the immune system to fight infections. If you develop a serious infection while taking Humira, you should discontinue the treatment.1
Before starting treatment with Humira, you should be tested for latent TB, and, if positive, you should receive treatment for TB before starting Humira. All patients should be monitored for active TB during treatment with Humira.1
The signs of TB include a cough that persists, a low-grade fever, weight loss, and loss of body fat and muscle.
If you carry the hepatitis B virus (HBV), a virus that affects the liver, HBV may become active during treatment with Humira. Before you start treatment with Humira, as well as during treatment and for several months after you stop treatment, your doctor will give you a blood test to see if you have HBV infection. The signs of HBV infection include muscle aches, fatigue, yellow-looking skin or eyes, dark urine, clay-colored bowel movements, vomiting, fever, chills, stomach ache, skin rash, and loss of appetite. Tell your doctor if you have any of these symptoms.
Humira and other anti-TNF treatments have been shown to increase the risk of developing certain types of cancers. While this risk is small, it does exist. Cases of lymphoma have occurred in children and adolescents who received Humira and other anti-TNF treatments. Humira may increase the risk of developing two types of skin cancers, basal cell cancer and squamous cell cancer of the skin.1
Other health conditions. Humira can cause a worsening of congestive heart failure (signs include shortness of breath, swelling of feet or ankles, and sudden weight gain), demyelinating disease (such as MS), a Lupus-like autoimmune disorder, or cytopenia (a deficiency of cells that make up blood, with symptoms including bruising, bleeding, or persistent fever). If you experience any of these conditions, contact your doctor immediately.1 Patients diagnosed with multiple sclerosis or other demyelinating disease should not use Humira.
Pregnancy and nursing
Humira is a pregnancy category B drug. Results from animal studies indicated no harm to the fetus when Humira was taken during pregnancy. However, because there have been no well-controlled studies in pregnant women. Humira should be used during pregnancy only if it is clearly needed.1
It is not known whether Humira is excreted into human milk. Because of the risk of adverse effects, women who are taking Humira should either not breastfeed or discontinue the drug while breastfeeding.1
Because of the increased risk for developing infections, you should not take Orencia (abatacept), Kineret (anakinra), Remicade (infliximab), Enbrel (etanercept), Cimzia (certolizumab pegol), Rituxan (rituximab), or Simponi (golimumab) while you are taking Humira.1
Use of live vaccines should be avoided while taking Humira.1
Taking Humira may influence the way your body metabolizes other drugs. Therefore, the doses of these drugs may need to be changed. Drugs that are affected in this way include warfarin (Coumadin), cyclosporine, and theophylline.1