Febuxostat Accord
Febuxostat Accord tablets contain febuxostat and are used to treat gout by lowering uric acid levels in the body.
Form
tabletti, kalvopäällysteinen
Strength
120 mg
Active Ingredient
Febuxostat
Manufacturer
Accord Healthcare B.V.
How to Use
Dosage
The usual dose is one tablet daily.
Method
The tablets are taken orally, with or without food.
Important
The maximum daily dose is one tablet.
Possible Side Effects
COMMON
- •Abnormal liver test results
- •Diarrhea
- •Headache
- •Rash (including different types of rashes)
- •Nausea
- •Increased gout symptoms
- •Local swelling due to fluid retention (edema)
- •Dizziness
- •Shortness of breath
- •Itching
- •Limb pain, muscle or joint pain/ache
- •Fatigue
RARE
- •Decreased appetite
- •Changes in blood sugar values (diabetes), intense thirst, increased blood fat levels, weight gain
- •Decreased libido
- •Sleep difficulties, drowsiness
- •Numbness, tingling, decreased or altered sense of touch (hypoesthesia, hemiparesis or paresthesias)
- •Altered taste, impaired sense of smell (hyposmia)
- •Abnormal EKG findings, irregular or rapid heartbeat, feeling your heart beat (palpitations)
- •Hot flashes or flushing (e.g., redness of the face or neck), increased blood pressure
- •Bleeding (observed only in patients receiving chemotherapy for blood cancer)
- •Cough, uncomfortable feeling or pain in the chest, inflammation of the nasal passages and/or throat (upper respiratory tract infection), bronchitis, lower respiratory tract infection
- •Dry mouth, pain/discomfort in the abdomen or flatulence, upper abdominal pain, heartburn/indigestion, constipation, increased urge to defecate, vomiting, uncomfortable feeling in stomach
- •Itchy rash, hives, skin inflammation or discoloration, small red or purple spots on the skin, small flat red spots on the skin, flat red areas covered with small raised bumps, rash, red areas and spots on the skin, increased sweating, night sweats, hair loss, redness of the skin (erythema), psoriasis, eczema, other skin symptoms
- •Muscle cramps, muscle weakness, inflammation of the joint bursa or joint inflammation (usually associated with pain, swelling and/or stiffness), back pain, muscle spasms, stiffness of muscles and/or joints
- •Blood in urine, unusually frequent urination, abnormal urine tests (more protein in urine than usual), impaired kidney function, urinary tract infection
- •Chest pain, uncomfortable feeling in chest
- •Gallbladder or bile duct stones (cholelithiasis)
- •Increased TSH levels
- •Changes in blood chemistry or blood cell counts or platelet counts
- •Kidney stones
- •Erectile dysfunction
- •Underactive thyroid, blurred vision, changes in vision
- •Tinnitus (ringing in the ears)
- •Runny nose
- •Mouth ulcers, pancreatitis (common symptoms: abdominal pain, nausea, vomiting)
- •Urgent need to urinate
- •Pain, malaise
- •Increased INR, bruising, lip swelling
- •Muscle damage, which can be severe in rare cases, potentially causing muscle problems, especially if accompanied by a feeling of illness or high fever, due to abnormal muscle breakdown.
- •Severe swelling of deep skin layers, especially around the eyes, genitals, hands, feet, or tongue, which may be accompanied by sudden breathing difficulties.
- •High fever with measles-like rash, enlarged lymph nodes, liver enlargement, liver inflammation (including liver damage), increased white blood cell count (Drug Reaction with Eosinophilia and Systemic Symptoms, DRESS).
- •Various types of rashes (e.g., papular, bullous, pustular, exfoliative, measles-like), widespread redness of the skin, necrosis and blistering detachment of the epidermis and mucous membranes, causing peeling and possibly sepsis (Stevens-Johnson syndrome/toxic epidermal necrolysis).
- •Nervousness
- •Thirst
- •Weight loss, increased appetite, uncontrolled loss of appetite (anorexia)
- •Abnormally low blood cell count (white or red blood cells or platelets)
- •Changes in urine volume or decreased urine volume due to kidney inflammation (tubulointerstitial nephritis)
- •Hepatitis
- •Yellowing of the skin (jaundice)
- •Bladder infection
- •Liver damage
- •Increased blood creatine phosphokinase levels (sign of muscle damage)
- •Sudden cardiac death
- •Low red blood cell count (anemia)
- •Depression
- •Sleep disturbances
- •Loss of taste
- •Burning sensation
- •Vertigo (sensation of spinning), circulatory collapse
- •Lung infection (pneumonia)
- •Mouth ulcers, inflammation of the mouth
- •Gastrointestinal perforation
- •Rotator cuff syndrome
- •Polymyalgia rheumatica
- •Feeling hot
- •Sudden vision loss due to retinal artery occlusion
Important Warnings
- Do not use Febuxostat Accord if you are allergic to febuxostat or any other ingredient in this medicine.
- Talk to your doctor if you have or have had heart failure, heart problems, or a stroke.
- Talk to your doctor if you have or have had kidney disease and/or a severe allergic reaction to allopurinol.
- Talk to your doctor if you have or have had liver disease or abnormal liver function test results.
- Talk to your doctor if you are being treated for high uric acid levels due to Lesch-Nyhan syndrome.
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- Talk to your doctor if you have thyroid problems.
- If you develop an allergic reaction to Febuxostat Accord, stop using it and seek immediate medical attention.
- Febuxostat use has rarely been associated with life-threatening rashes, such as Stevens-Johnson syndrome; if you develop a rash or other skin symptoms, contact your doctor immediately.
- If you are currently having a gout attack, wait for it to subside before starting Febuxostat Accord.
- This medicine should not be given to children under 18 years of age.
- Do not use Febuxostat Accord during pregnancy.
- Do not use Febuxostat Accord while breastfeeding.
- Do not drive or operate machinery if you experience dizziness, drowsiness, blurred vision, or numbness.