Humira Side Effects
Generic name: adalimumab
Note: This document contains side effect information about adalimumab. Some of the dosage forms listed on this page may not apply to the brand name Humira.
Some side effects of Humira may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
For the Consumer
Applies to adalimumab: subcutaneous kit
Get emergency medical help if you have any of these signs of an allergic reaction while taking adalimumab (the active ingredient contained in Humira) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using adalimumab and call your doctor right away if you have any of these symptoms of lymphoma:
fever, night sweats, weight loss, tiredness;
feeling full after eating only a small amount;
pain in your upper stomach that may spread to your shoulder;
easy bruising or bleeding, pale skin, feeling light-headed, rapid heart rate; or
liver problems--nausea, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Stop using adalimumab and call your doctor at once if you have any of these other serious side effects:
signs of infection (fever, chills, sore throat, vomiting, diarrhea, flu symptoms);
shortness of breath with swelling of your ankles or feet;
confusion, neck stiffness, seizure (convulsions);
pain or burning when you urinate;
sudden numbness or weakness, sudden severe headache, problems with vision or balance;
chest pain, sudden or ongoing cough, wheezing, rapid breathing, coughing up mucus or blood;
tingly feeling, weakness or prickly feeling in your fingers or toes;
problems with balance or eye movement, trouble speaking or swallowing;
severe lower back pain, loss of bladder or bowel control;
pain, swelling, warmth, or redness in one or both legs;
red, purple, or scaly skin rash, hair loss, muscle pain, mouth sores;
joint pain or swelling, swollen glands, muscle aches, unusual thoughts or behavior; or
patchy skin color, red spots, or a butterfly-shaped skin rash over your cheeks and nose (worsens in sunlight).
Other common side effects may include:
stuffy nose, sinus pain;
mild stomach pain; or
pain, redness, itching, swelling, or bleeding where you injected the medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.
For Healthcare Professionals
Applies to adalimumab: subcutaneous kit
The most serious adverse reactions associated with adalimumab (the active ingredient contained in Humira) have been serious infections, neurologic events, and malignancies. The most common adverse reactions have been injection site reactions. In clinical trials, 7% of patients discontinued treatment due to adverse events (vs 4% with placebo).
The incidence of infection was 1 per patient year (vs. 0.9 with placebo). The most common infections were upper respiratory tract infections (17%), bronchitis, and urinary tract infections (8%). The incidence of serious infections was 0.04 per patient year (vs. 0.02 with placebo). Serious infections included pneumonia, septic arthritis, prosthetic and postsurgical infections, erysipelas, cellulitis, diverticulitis, pyelonephritis, tuberculosis (13 cases), and invasive opportunistic infections (6 cases). One fatality due to herpes zoster with secondary streptococcal necrotizing fasciitis was reported during a clinical trial (n=636). A leprosy reaction has been reported following discontinuation of adalimumab (the active ingredient contained in Humira)
Most of the tuberculosis cases occurred within the first 8 months of therapy and included miliary, lymphatic, peritoneal, and pulmonary types. Opportunistic infections were due to histoplasma, aspergillus, and nocardia.
Nervous system side effects have included headache (12%). Confusion, multiple sclerosis, paresthesia, subdural hematoma, and tremor have been reported in less than 5% of patients. A case of hypertrophic pachymeningitis has also been reported. Adalimumab (the active ingredient contained in Humira) and other TNF blockers have been associated with symptoms or evidence suggestive of demyelinating disease. Postmarketing reports have included demyelinating disorders (optic neuritis, Guillain-Barré syndrome) and cerebrovascular accident.
During the controlled portions of adalimumab (the active ingredient contained in Humira) trials in patients with moderately to severely active rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis, malignancies (other than lymphoma and non-melanoma skin cancer) were observed at a rate of 0.7 per 100 patient-years among adalimumab-treated patients versus a rate of 0.3 per 100 patient-years among control patients. The median duration of treatment was 5.7 months for adalimumab-treated patients and 5.5 months for control-treated patients.
During the controlled portions of adalimumab rheumatoid arthritis trials, the rate of non-melanoma skin cancers was 0.9 per 100 patient-years among adalimumab-treated patients and 0.2 per 100 patient-years among control patients.
More cases of malignancies have been observed among patients receiving TNF blockers, including adalimumab, compared to controls. Patients with rheumatoid arthritis, particularly those with highly active disease, are at a higher risk for the development of lymphoma.
A meta-analysis has reported that there is dose-dependent increased risk of malignancies in patients with rheumatoid arthritis treated with anti-TNF antibody therapy.
Oncologic side effects have included adenoma, carcinomas (breast, gastrointestinal, skin, urogenital), lymphoma, and melanoma in less than 5% of patients. A case of acute myelogenic leukemia has also been reported. A rare cancer of the white blood cells (known as Hepatosplenic T-Cell Lymphoma or HSTCL), mostly in adolescents and young adults being treated with tumor necrosis factors (TNF) blockers, continues to be reported to FDA.
Immunologic side effects have included development of autoantibodies. Postmarketing reports have included sarcoidosis.
Positive ANA titers were observed at week 24 in 12% of patients (vs 7% with placebo). One patient (0.04%) developed symptoms of new-onset lupus-like syndrome and recovered after discontinuation of adalimumab.
Low-titer antibodies to adalimumab have been observed at least once during treatment in 5% of patients (n=1062). Antibodies developed in 12% of patients on adalimumab monotherapy and in 1% of patients on concurrent methotrexate. During monotherapy, the ACR20 (American College of Rheumatology criteria) response was lower in antibody-positive patients.
A meta-analysis has reported that there is evidence of an increased risk of serious infections in patients with rheumatoid arthritis treated with anti-TNF antibody therapy.
Musculoskeletal side effects have included back pain in 6% of patients; and arthritis, bone disorder, nonspontaneous bone fracture, bone necrosis, joint disorder, muscle cramps, myasthenia, pyogenic arthritis, synovitis, and tendon disorder in less than 5% of patients. A case of severe myalgia has also been reported.
Respiratory side effects have included upper respiratory infection (17%), sinusitis (11%), and flu syndrome (7%). Asthma, bronchospasm, dyspnea, lung disorder, decrease lung function, pleural effusion, pneumonia, and interstitial lung disease including pulmonary fibrosis have been reported in less than 5% of patients. Postmarketing reports have included interstitial lung disease (including pulmonary fibrosis) and pulmonary embolism.
Gastrointestinal side effects have included nausea (9%) and abdominal pain (7%). Cholecystitis, cholelithiasis, esophagitis, gastroenteritis, gastrointestinal disorder, gastrointestinal hemorrhage, hepatic necrosis, and vomiting have been reported in less than 5% of patients. Postmarketing reports have included diverticulitis, large bowel perforations including perforations associated with diverticulitis and appendiceal perforations associated with appendicitis, and pancreatitis.
Metabolic side effects have included hypercholesterolemia (6%), hyperlipidemia (7%), increased alkaline phosphatase (5%), and unspecified abnormal laboratory tests (8%). Dehydration, abnormal healing, ketosis, paraproteinemia, and peripheral edema have been reported in less than 5% of patients.
Genitourinary side effects have included urinary tract infection (8%) and hematuria (5%). Cystitis, kidney calculus, menstrual disorder and pyelonephritis have been reported in less than 5% of patients.
Local side effects have included injection site pain (12%) and injection site reaction (8%).
Dermatologic side effects have included rash (12%). Cellulitis, erysipelas, cutaneous vasculitis, and herpes zoster have been reported in less than 5% of patients. There have been postmarketing reports of Stevens Johnson Syndrome, cutaneous vasculitis, erythema multiforme, new or worsening psoriasis (all subtypes including pustular and palmoplantar) and alopecia.
Cardiovascular side effects have included hypertension (5%). Arrhythmia, atrial fibrillation, cardiovascular disorder, chest pain, congestive heart failure, coronary artery disorder, heart arrest, hypertensive encephalopathy, myocardial infarct, palpitation, pericardial effusion, pericarditis, syncope, tachycardia, and vascular disorder have been reported in less than 5% of patients. There have been postmarketing reports of systemic vasculitis and deep vein thrombosis.
Cases of worsening congestive heart failure (CHF) and new onset CHF have been reported with TNF blockers, including adalimumab. In clinical studies of another TNF blocker, a higher rate of serious CHF-related adverse events was observed.
Endocrine side effects have included parathyroid disorder in less than 5% of patients.
Hematologic side effects have included agranulocytosis, granulocytopenia, leukopenia, thrombocytopenia, lymphoma-like reaction, pancytopenia, polycythemia, and leg thrombosis in less than 5% of patients. A case of hypertriglyceridemia has also been reported.
Side effects affecting the body as a whole have included fever, infection, extremity pain, pelvic pain, sepsis, surgery, thorax pain, and reactivated tuberculosis in less than 5% of patients.
Accidental injury has been reported in 10% of patients.
Ocular side effects have included cataract (<5%).
Hypersensitivity side effects including anaphylaxis and angioneurotic edema have been reported.
Hepatic side effects have included postmarketing reports of liver failure.
More Humira resources
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