Adalimumab Side Effects

Not all side effects for adalimumab may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to adalimumab: subcutaneous solution

In addition to its needed effects, some unwanted effects may be caused by adalimumab. In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking adalimumab:

More common
  • Abdominal or stomach fullness
  • body aches or pain
  • cough or hoarseness
  • ear congestion
  • gas with abdominal or stomach pain
  • lightheadedness
  • loss of voice
  • lower back or side pain
  • muscle aches and pains
  • nasal congestion
  • pain or tenderness around the eyes or cheekbones
  • rapid and sometimes shallow breathing
  • shivering
  • sunken eyes
  • thirst
  • trouble sleeping
  • warmth on the skin
  • wrinkled skin
Less common
  • A sore on the skin of the breast that does not heal
  • abdominal or stomach pain
  • abnormal vaginal bleeding or discharge
  • agitation
  • arm, back, or jaw pain
  • back pain
  • black, tarry stools
  • bleeding from the gums or nose
  • blindness
  • bloating or swelling of the face, arms, hands, lower legs, or feet
  • blood in the stool or change in bowel habits
  • bloody or cloudy urine
  • blurred vision
  • broken bones
  • change in size, shape, or color of an existing mole
  • change in skin color
  • chest pain
  • chest tightness or heaviness
  • chills
  • clear or bloody discharge from the nipple
  • cold hands and feet
  • confusion
  • constipation
  • cough
  • coughing or spitting up blood
  • decreased urination
  • decreased vision
  • depression
  • difficult or frequent urination
  • difficulty with breathing
  • difficulty, burning, or painful urination
  • dimpling of the breast skin
  • dizziness
  • drowsiness
  • eye pain
  • fainting
  • fast, slow, or irregular heartbeat
  • fever
  • forgetfulness
  • frequent urge to urinate
  • general feeling of illness
  • hair loss
  • hallucinations
  • headache
  • increased thirst
  • inverted nipple
  • irregular breathing
  • irregular pulse
  • irritability
  • itching
  • light colored stools
  • loss of appetite
  • lump in the breast or under your arm
  • lump or swelling in the abdomen or stomach
  • mole that leaks fluid or bleeds
  • muscle cramps or spasms
  • nausea
  • new mole
  • night sweats
  • no blood pressure or pulse
  • noisy breathing
  • numbness or tingling in your arms, legs, or face
  • pain, redness, or swelling in the arms or legs without any injury present
  • pale skin
  • persistent non-healing sore on your skin
  • pink growth
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • raised, firm, or bright red patch
  • rash
  • redness or swelling of the breast
  • seizures
  • sharp back pain just below your ribs
  • shiny bump on your skin
  • skin rash
  • slurred speech or problems with swallowing
  • sneezing
  • sore throat
  • sores, ulcers, or white spots on the lips or mouth
  • spitting up blood
  • stiff neck
  • stopping of the heart
  • sudden high fever or low grade fever for months
  • sweating
  • swelling of the face, fingers, feet, or lower legs
  • swollen glands
  • swollen neck veins
  • tightness in the chest
  • tiredness
  • trouble breathing with activity
  • trouble thinking
  • unconsciousness
  • unexplained bruising or bleeding
  • unpleasant breath odor
  • unusual tiredness or weakness
  • unusual weight gain or loss
  • visual disturbances
  • vomiting
  • vomiting of blood or material that looks like coffee grounds
  • yellow skin or eyes
Incidence not known
  • Blistering, peeling, or loosening of the skin
  • diarrhea
  • joint or muscle pain
  • pinpoint red spots on the skin
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • red, scaling, or crusted skin
  • unusual bleeding or bruising

Some of the side effects that can occur with adalimumab may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common
  • Bladder pain
  • bleeding
  • burning
  • coldness
  • discoloration of the skin
  • feeling of pressure
  • general feeling of discomfort or illness
  • hives
  • lumps
  • numbness
  • pounding in the ears
  • redness
  • scarring
  • soreness
  • stinging
  • swelling
  • tenderness
  • tingling
  • ulceration
  • warmth
Less common
  • Abnormal healing
  • decrease in height
  • difficulty with moving
  • difficulty with swallowing
  • difficulty with walking
  • dry mouth
  • heartburn
  • indigestion
  • loss of hearing
  • loss of strength or energy
  • menstrual changes
  • muscle or joint stiffness, tightness, or rigidity
  • muscle pain or weakness
  • pain in the back, ribs, arms, or legs
  • shakiness in the legs, arms, hands, and feet
  • sores
  • stomach pain, fullness, or discomfort
  • swelling or redness in the joints
  • weakness

For Healthcare Professionals

Applies to adalimumab: subcutaneous kit

General

The most serious adverse reactions associated with adalimumab 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).[Ref]

Other

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.[Ref]

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.[Ref]

Nervous system

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 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.[Ref]

Oncologic

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.[Ref]

During the controlled portions of adalimumab 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.[Ref]

Immunologic

Immunologic side effects have included development of autoantibodies. Postmarketing reports have included sarcoidosis.[Ref]

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.[Ref]

Musculoskeletal

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.[Ref]

Respiratory

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.[Ref]

Gastrointestinal

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.[Ref]

Metabolic

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.[Ref]

Genitourinary

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.[Ref]

Local

Local side effects have included injection site pain (12%) and injection site reaction (8%).[Ref]

Dermatologic

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.[Ref]

Cardiovascular

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.[Ref]

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.[Ref]

Endocrine

Endocrine side effects have included parathyroid disorder in less than 5% of patients.[Ref]

Hematologic

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.[Ref]

Ocular

Ocular side effects have included cataract (<5%).[Ref]

Hypersensitivity

Hypersensitivity side effects including anaphylaxis and angioneurotic edema have been reported.[Ref]

Hepatic

Hepatic side effects have included postmarketing reports of liver failure.[Ref]

References

1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

2. von Mehren M, Schilder RJ, Cheng JD, et al. "A phase I study of the safety and pharmacokinetics of trabectedin in combination with pegylated liposomal doxorubicin in patients with advanced malignancies." Ann Oncol 19 (2008): 1802-9

3. "Product Information. Humira (adalimumab)." Abbott Pharmaceutical, Abbott Park, IL.

4. Camacho ID, Valencia I, Rivas MP, Burdick AE "Type 1 leprosy reaction manifesting after discontinuation of adalimumab therapy." Arch Dermatol 145 (2009): 349-51

5. Furst DE, Schiff MH, Fleischmann RM, et al. "Adalimumab, a fully human anti tumor necrosis factor-alpha monoclonal antibody, and concomitant standard antirheumatic therapy for the treatment of rheumatoid arthritis: results of STAR (Safety Trial of Adalimumab in Rheumatoid Arthritis)." J Rheumatol 30 (2003): 2563-71

6. Ahmed M, Luggen M, Herman JH, et al. "Hypertrophic pachymeningitis in rheumatoid arthritis after adalimumab administration." J Rheumatol 33 (2006): 2344-6

7. Bensouda-Grimaldi L, Mulleman D, Valat JP, Autret-Leca E "Adalimumab-associated multiple sclerosis." J Rheumatol 34 (2007): 239

8. Saba NS, Kosseifi SG, Charaf EA, Hammad AN "Adalimumab-induced acute myelogenic leukemia." South Med J 101 (2008): 1261-2

9. Bongartz T, Sutton AJ, Sweeting MJ, Buchan I, Matteson EL, Montori V "Anti-TNF antibody therapy in rheumatoid arthritis and the risk of serious infections and malignancies: systematic review and meta-analysis of rare harmful effects in randomized controlled trials." JAMA 295 (2006): 2275-85

10. Hinojosa J, Borras-Blasco J, Maroto N, Rosique-Robles JD, Alos R, Castera ME "Severe myalgia associated with adalimumab treatment in a patient with Crohn's disease." Ann Pharmacother 42 (2008): 1130-3

11. Garcia Bartels N, Lee HH, Worm M, Burmester GR, Sterry W, Blume-Peytavi U "Development of alopecia areata universalis in a patient receiving adalimumab." Arch Dermatol 142 (2006): 1654-3

12. Orpin SD, Majmudar VB, Soon C, Azam NA, Salim A "Adalimumab causing vasculitis." Br J Dermatol 154 (2006): 998-9

13. Stinco G, Piccirillo F, Patrone P "Hypertriglyceridaemia during treatment with adalimumab in psoriatic arthritis." Br J Dermatol 157 (2007): 1273-4

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