Note: This document contains side effect information about adalimumab. Some dosage forms listed on this page may not apply to the brand name Amjevita.

Applies to adalimumab: subcutaneous solution.

Serious side effects of Amjevita

Along with its needed effects, adalimumab (the active ingredient contained in Amjevita) 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

• Bladder pain
• bloody or cloudy urine
• blurred vision
• chest pain or tightness
• chills
• cough
• difficult, burning, or painful urination
• dizziness
• ear congestion or pain
• fever
• frequent urge to urinate
• head congestion
• headache
• hoarseness or other voice changes
• lower back or side pain
• nervousness
• pain or tenderness around the eyes and cheekbones
• pounding in the ears
• slow or fast heartbeat
• sneezing
• sore throat
• stuffy or runny nose
• trouble breathing

Less common

• Abnormal healing
• agitation
• anxiety
• arm, back, jaw pain
• bleeding from the gums or nose
• blindness
• bloating or swelling of the face, arms, hands, lower legs, or feet
• bloody or black, tarry stools
• bloody or cloudy urine
• blue or pale skin
• bone pain or fractures
• burning, crawling, itching, numbness, prickling, "pins and needles" , or tingling feelings
• chest pain, discomfort, tightness, or heaviness
• coma
• confusion
• cough or hoarseness
• dark urine
• decreased vision
• depression
• diarrhea
• difficulty in moving
• difficulty in swallowing
• drowsiness
• dry mouth
• dry skin
• eye pain
• fainting
• feeling of illness
• frequent urge to urinate
• gaseous stomach pain
• hair loss
• hallucinations
• heartburn
• increased thirst
• increased urination
• indigestion
• irritability
• itching, skin rash
• loss of appetite
• loss of strength or energy
• light-colored stools
• lower back or side pain
• mood or mental changes
• muscle pain, stiffness, cramps, tightness, rigidity, or spasms
• nausea
• no blood pressure or pulse
• pain, swelling, or redness in the joints
• pain in the arms or legs
• pain in the groin or genitals
• pain or burning in the throat
• painful or difficult urination
• pale skin
• pelvic pain
• rapid breathing
• rapid weight gain or loss
• recurrent fever
• redness or swelling of the lower leg
• ringing in the ears
• unconsciousness
• seizures
• shakiness in the legs, arms, hands, or feet
• sharp back pain just below ribs
• sore throat
• sores, ulcers, or white spots on the lips or tongue or inside the mouth
• stiff neck
• stomach pain
• stopping of the heart
• sunken eyes
• sweating
• tingling of the hands or feet
• trembling or shaking of the hands or feet
• trouble thinking
• unpleasant breath odor
• unusual bleeding or bruising
• unusual weight gain or loss
• visual disturbances
• vomiting
• vomiting of blood or material that looks like coffee grounds
• wrinkled skin
• yellow eyes or skin

Incidence not known

• Blindness
• blistering, peeling, or loosening of the skin
• decreased urine output
• decreased vision
• dilated neck veins
• irregular breathing
• irregular heartbeat
• red, irritated eyes
• red skin lesions, often with a purple center
• swelling of the face, fingers, feet, or lower legs
• unusual tiredness or weakness
• weight gain

Other side effects of Amjevita

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

• Bleeding, blistering, burning, coldness, discoloration of the 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

For Healthcare Professionals

Applies to adalimumab: subcutaneous kit, subcutaneous solution.

Cardiovascular

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^[Ref]

Dermatologic

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^[Ref]

Endocrine

Uncommon (0.1% to 1%): Parathyroid disorder^[Ref]

Gastrointestinal

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^[Ref]

Genitourinary

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

Uncommon (0.1% to 1%): Cystitis, kidney calculus, menstrual disorder, pyelonephritis^[Ref]

Hematologic

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^[Ref]

Hepatic

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

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

Postmarketing reports: Hepatic failure^[Ref]

Hypersensitivity

Frequency not reported: Anaphylaxis, angioneurotic edema^[Ref]

Immunologic

Common (1% to 10%): Flu syndrome

Uncommon (0.1% to 1%): Sarcoidosis

Frequency not reported: Development of autoantibodies^[Ref]

Local

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

Common (1% to 10%): Injection site reaction^[Ref]

Metabolic

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

Uncommon (0.1% to 1%): Dehydration, ketosis, paraproteinemia, increased alkaline phosphatase^[Ref]

Musculoskeletal

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^[Ref]

Nervous system

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^[Ref]

Ocular

Uncommon (0.1% to 1%): Optic neuritis, cataract^[Ref]

Oncologic

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^[Ref]

Other

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^[Ref]

Renal

Frequency not reported: Renal pain, renal impairment^[Ref]

Respiratory

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^[Ref]

Psychiatric

Common (1% to 10%): Mood alterations (including depression), anxiety, insomnia^[Ref]