Adalimumab Side Effects

Medically reviewed by Philip Thornton, DipPharm. Last updated on Aug 31, 2023.

Summary

Commonly reported side effects of adalimumab 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. Continue reading for a comprehensive list of adverse effects.

Applies to adalimumab: subcutaneous solution.

Warning

Subcutaneous route (Solution)

Serious InfectionsIncreased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections due to other opportunistic pathogens.Discontinue adalimumab-bwwd if a patient develops a serious infection or sepsis during treatment.Perform test for latent TB; if positive, start treatment for TB prior to starting adalimumab-bwwd.Monitor all patients for active TB during treatment, even if initial latent TB test is negative.MalignancyLymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF-blockers including adalimumab products.Post-marketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have occurred in adolescent and young adults with inflammatory bowel disease treated with TNF-blockers including adalimumab products.

Serious side effects of Adalimumab

Along with its needed effects, adalimumab 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 Adalimumab

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]