Humira Pen-cd/uc/hs Start

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.

Common side effects of Humira include: upper respiratory tract infection, headache, injection site reaction, skin rash, antibody development, sinusitis, and pain at injection site. Other side effects include: urinary tract infection, abdominal pain, and flu-like symptoms. See below for a comprehensive list of adverse effects.

Applies to adalimumab: subcutaneous solution

Along with its needed effects, adalimumab (the active ingredient contained in Humira) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking adalimumab:

More common

• Body aches or pain
• cough
• ear congestion
• gas with abdominal or stomach pain
• hoarseness
• 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
• stomach fullness
• sunken eyes
• thirst
• trouble sleeping
• warmth on the skin
• wrinkled skin

Less common

• Abnormal vaginal bleeding or discharge
• agitation
• arm, back, or jaw 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, 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
• 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
• headache
• hives, itching, skin rash
• increased thirst
• inverted nipple
• irregular breathing
• irregular pulse
• irritability
• 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
• redness or swelling of the breast
• seeing or hearing things that are not there
• seizures
• sharp back pain just below your ribs
• shiny bump on your skin
• slurred speech or problems with swallowing
• sneezing
• sore on the skin of the breast that does not heal
• sore throat
• sores, ulcers, or white spots on the lips or mouth
• spitting up blood
• stiff neck
• stomach pain
• 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
• tiredness
• troubled 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 side effects of adalimumab may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Bladder pain
• bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
• pounding in the ears

Less common

• Abnormal healing
• decrease in height
• difficulty with moving
• 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
• swelling or redness in the joints

Applies to adalimumab: subcutaneous kit, subcutaneous solution

Common (1% to 10%): Hypertension

Uncommon (0.1% to 1%): Arrhythmia, atrial fibrillation, chest pain, coronary artery disorder, heart arrest, hypertensive encephalopathy, myocardial infarct, palpitation, pericardial effusion, pericarditis, syncope, tachycardia, congestive heart failure, peripheral edema, systemic vasculitis, deep vein thrombosis

Rare (less than 0.1%): Vascular occlusion, aortic stenosis, thrombophlebitis, aortic aneurysm

Very common (10% or more): Rash (12%)

Common (1% to 10%): Dermatitis, eczema, pruritus, cellulitis, urticaria, psoriasis, ecchymosis, increased bruising, purpura, erysipelas, cutaneous vasculitis, herpes zoster

Postmarketing reports: Stevens Johnson Syndrome, cutaneous vasculitis, erythema multiforme, new or worsening psoriasis (all subtypes including pustular and palmoplantar), alopecia, erythema multiforme, panniculitis

Uncommon (0.1% to 1%): Parathyroid disorder

Common (1% to 10%): Diarrhea, nausea, abdominal pain, vomiting, stomatitis, mouth ulceration

Uncommon (0.1% to 1%): Cholecystitis, cholelithiasis, gastroenteritis, gastrointestinal hemorrhage, gastritis, dyspepsia, gastrointestinal disorder, gastrointestinal hemorrhage, rectal hemorrhage, abdominal bloating

Rare (less than 0.1%): Esophagitis, intestinal stenosis, colitis, enteritis

Frequency not reported: Diverticulitis, large bowel perforations including perforations associated with diverticulitis and appendiceal perforations associated with appendicitis, pancreatitis

Common (1% to 10%): Urinary tract infection, hematuria

Uncommon (0.1% to 1%): Cystitis, kidney calculus, menstrual disorder, pyelonephritis

Common (1% to 10%): Lymphopenia, agranulocytosis, granulocytopenia, leucopenia, thrombocytopenia, anemia, lymphadenopathy, leukocytosis

Rare (less than 0.1%): Pancytopenia, polycythemia, idiopathic thrombocytopenia purpura, lymphoma-like reaction, leg thrombosis, hypertriglyceridemia

Uncommon (0.1% to 1%): Liver failure, hepatitis

Rare (less than 0.1%): Hepatic enzymes increased, hepatic necrosis

Postmarketing reports: Hepatic failure

Frequency not reported: Anaphylaxis, angioneurotic edema

Common (1% to 10%): Flu syndrome

Uncommon (0.1% to 1%): Sarcoidosis

Frequency not reported: Development of autoantibodies

Very common (10% or more): Injection site pain (12%)

Common (1% to 10%): Injection site reaction

Common (1% to 10%): Hypercholesterolemia, hyperlipidemia

Uncommon (0.1% to 1%): Dehydration, ketosis, paraproteinemia, increased alkaline phosphatase

Common (1% to 10%): Back pain

Uncommon (0.1% to 1%): Arthritis, bone disorder, bone fracture (not spontaneous), bone necrosis, joint disorder, muscle cramps, myasthenia, pyogenic arthritis, synovitis, tendon disorder, pelvic pain

Rare (less than 0.1%): Rhabdomyolysis

Very common (10% or more): Headache (12%)

Uncommon (0.1% to 1%): Confusion, paraesthesia, subdural hematoma, tremor, demyelinating disorders (e.g., optic neuritis, Guillain-Barre syndrome), cerebrovascular accident, multiple sclerosis,

Very rare (less than 0.01%): Hypertrophic pachymeningitis

Uncommon (0.1% to 1%): Optic neuritis, cataract

Uncommon (0.1% to 1%): Adenoma, Merkel Cell Carcinoma (neuroendocrine carcinoma of the skin)

Rare (less than 0.1%): Skin papilloma, carcinomas (breast, gastrointestinal, skin, testicular), lymphoma, melanoma, cancer of the white blood cells (known as Hepatosplenic T-Cell Lymphoma or HSTCL), mostly in adolescents and young adults

Very common (10% or more): Accidental injury (10%)

Uncommon (0.1% to 1%): Pain in extremity, thorax pain

Rare (less than 0.1%): Pyrexia

Frequency not reported: Sepsis, pain in thorax, opportunistic infections, tuberculosis, histoplasmosis, abscess, joint infection, wound infection, superficial fungal infections

Frequency not reported: Renal pain, renal impairment

Very common (10% or more): Upper respiratory infection (17%), sinusitis (11%), pneumonia, pharyngitis, nasopharyngitis

Uncommon (0.1% to 1%): Asthma, bronchospasm, dyspnea, lung function decreased, pleural effusion, interstitial lung disease (including pulmonary fibrosis), pulmonary embolism

Frequency not reported: Cough, upper respiratory infection, pharyngeal edema, nasal congestion, pulmonary edema, pleural effusion, pleurisy

Common (1% to 10%): Mood alterations (including depression), anxiety, insomnia