Adalimumab (Subcutaneous Route)

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Side Effects

Along with its needed effects, a medicine 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:

• 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
• Runny nose
• Shivering
• Stuffy nose
• Sunken eyes
• Thirst
• Trouble sleeping
• Warmth on the skin
• Wrinkled skin

• A sore on the skin of the breast that does not heal
• Abdominal or stomach pain
• Abnormal vaginal bleeding or discharge
• Agitation
• Anxiety
• 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
• Mood or mental changes
• 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
• Shortness of breath
• 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
• Wheezing

• 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 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:

• 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

• 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
• Pain or burning in the throat
• Passing of gas
• Shakiness in the legs, arms, hands, and feet
• Sores
• Stomach pain, fullness, or discomfort
• Swelling or redness in the joints
• Weakness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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