Uloric Side Effects
Generic Name: febuxostat
Note: This document contains side effect information about febuxostat. Some of the dosage forms listed on this page may not apply to the brand name Uloric.
Some side effects of Uloric may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
For the Consumer
Applies to febuxostat: oral tablet
Along with its needed effects, febuxostat (the active ingredient contained in Uloric) 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 febuxostat:Rare
- Abdominal or stomach fullness or pain
- arm, back, or jaw pain
- black, tarry stools
- bloody nose
- blurred vision
- chest pain or discomfort
- cloudy urine
- dark urine
- decreased frequency or amount of urine
- difficult or labored breathing
- difficulty with moving
- dry mouth
- fast, irregular, pounding, or racing heartbeat or pulse
- feeling of fullness
- gaseous abdominal or stomach pain
- general tiredness and weakness
- heavier menstrual periods
- inability to speak
- increase in heart rate
- increased thirst
- joint pain, stiffness, or swelling
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- loss of appetite
- loss of bladder control
- muscle aching or cramping
- nausea and vomiting
- pain, swelling, or redness in the joints
- painful or difficult urination
- pale skin
- pinpoint red spots on the skin
- pounding in the ears
- rapid breathing
- redness of the skin
- right upper abdominal or stomach pain and fullness
- runny nose
- severe or sudden headache
- shortness of breath
- slow or fast heartbeat
- slurred speech
- sore throat
- sores, ulcers, or white spots on the lips or in the mouth
- sunken eyes
- temporary blindness
- tightness in the chest
- trouble sleeping
- troubled breathing or swallowing
- unusual bleeding or bruising
- unusual tiredness or weakness
- vomiting of blood or material that looks like coffee grounds
- weakness in the arm or leg on one side of the body, sudden and severe
- weight gain
- wrinkled skin
- yellow eyes and skin
- Blistering, peeling, or loosening of the skin
- difficulty with swallowing
- muscle cramps or spasms
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- red skin lesions, often with a purple center
- red, irritated eyes
Some side effects of febuxostat 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:Rare
- Acid or sour stomach
- bad, unusual, or unpleasant (after) taste
- blistering, crusting, irritation, itching, or reddening of the skin
- body aches or pain
- breast pain
- burning feeling in the chest or stomach
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- change in taste
- changes in hair color
- continuing ringing or buzzing or other unexplained noise in the ears
- cough producing mucus
- cracked, dry, or scaly skin
- decrease in smell
- decreased interest in sexual intercourse
- ear congestion
- excess air or gas in the stomach or intestines
- feeling of constant movement of self or surroundings
- fruit-like breath odor
- gum pain
- hair loss or thinning of the hair
- hearing loss
- inability to have or keep an erection
- inability to move the arms and legs
- increased or decreased appetite
- increased sensitivity of the skin to sunlight
- increased sweating
- increased urination
- large, flat, blue, or purplish patches in the skin
- loss in sexual ability, desire, drive, or performance
- loss of appetite
- loss of consciousness
- loss of voice
- muscle or bone pain or stiffness
- muscle spasm, tightness, or weakness
- muscle twitching
- nasal congestion
- painful blisters on the trunk of the body
- pains in the stomach, side, or abdomen, possibly radiating to the back
- sensation of spinning
- severe or continuing stomach pain
- severe sunburn
- shakiness in the legs, arms, hands, or feet
- skin rash, encrusted, scaly, and oozing
- sleepiness or unusual drowsiness
- small red or purple spots on the skin
- stomach discomfort, upset, or pain
- sudden numbness and weakness in the arms and legs
- swelling of the breasts or breast soreness in both females and males
- throat irritation
- trembling or shaking of the hands or feet
- trouble sleeping
- unexplained weight loss
- unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
- weight loss
- Aggressive thoughts
For Healthcare Professionals
Applies to febuxostat: oral tablet
Hepatic side effects have included liver function abnormalities (4.6% to 6.6%). Hepatic side effects occurring in less than 1% of patients have included cholelithiasis/cholecystitis, hepatic steatosis, hepatitis, and hepatomegaly.
Postmarketing side effects have included hepatic failure (some fatal), jaundice, serious cases of abnormal liver function test results, and liver disorder.
Liver function abnormality in 1.2% to 1.8% of patients was the most common adverse reaction leading to discontinuation of febuxostat therapy. Liver function tests (e.g., AST, ALT) should be performed at 2 and 4 months following initiation of therapy and periodically thereafter.
Gastrointestinal side effects have included nausea (1.1% to 1.3%). Other gastrointestinal side effects occurring in less than 1% of patients have included abdominal distention, abdominal pain, constipation, dry mouth, dyspepsia, flatulence, frequent stools, gastritis, gastroesophageal reflux disease, gastrointestinal discomfort, gingival pain, hematemesis, hyperchlorhydria, hematochezia, mouth ulceration, pancreatitis, peptic ulcer, and vomiting.
Dermatologic side effects have included rash (0.5% to 1.6%). Dermatologic side effects occurring in less than 1% of patients have included alopecia, angioedema, dermatitis, dermographism, ecchymosis, eczema, hair color changes, hair growth abnormal, hyperhidrosis, peeling skin, petechiae, photosensitivity, pruritus, purpura, skin discoloration/altered pigmentation, skin lesion, skin odor abnormal, and urticaria. Generalized rash, Stevens Johnson Syndrome, and hypersensitivity skin reactions have been reported postmarketing.
Musculoskeletal side effects have included arthralgia (0.7% to 1.1%). Musculoskeletal side effects occurring in less than 1% of patients have included arthritis, joint stiffness, joint swelling, muscle spasms/twitching/tightness/weakness, musculoskeletal pain/stiffness, and myalgia. Rhabdomyolysis has been reported postmarketing.
Hematologic side effects occurring in less than 1% of patients have included anemia, idiopathic thrombocytopenic purpura, leukocytosis/leucopenia, neutropenia, pancytopenia, splenomegaly, and thrombocytopenia.
Cardiovascular side effects occurring in less than 1% of patients have included angina pectoris, atrial fibrillation/flutter, cardiac murmur, ECG abnormal, palpitations, sinus bradycardia, tachycardia, chest pain/discomfort, hypertension, and hypotension.
Immunologic side effects occurring in less than 1% of patients have included herpes zoster.
Metabolic side effects occurring in less than 1% of patients have included anorexia, appetite decreased/increased, dehydration, diabetes mellitus, hypercholesterolemia, hyperlipidemia, hypertriglyceridemia, hypokalemia, and weight increased/decreased.
Ocular side effects have included blurred vision.
Nervous system side effects occurring in less than 1% of patients have included altered taste, balance disorder, cerebrovascular accident, Guillain-Barre syndrome, headache, hemiparesis, hypoesthesia, hyposmia, lacunar infarction, lethargy, mental impairment, migraine, paresthesia, somnolence, transient ischemic attack, and tremor.
Psychiatric side effects occurring in less than 1% of patients have included agitation, anxiety, depression, insomnia, irritability, decreased libido, nervousness, panic attack, and personality change. Psychotic behavior including aggressive thoughts has been reported postmarketing.
Renal side effects occurring in less than 1% of patients have included hematuria, tubulointerstitial nephrolithiasis, pollakiuria, proteinuria, renal failure, renal insufficiency, urgency, and incontinence.
Respiratory side effects occurring in less than 1% of patients have included bronchitis, cough, dyspnea, epistaxis, nasal dryness, paranasal sinus hypersecretion, pharyngeal edema, respiratory tract congestion, sneezing, throat irritation, and upper respiratory tract infection.
Genitourinary side effects occurring in less than 1% of patients have included erectile dysfunction.
Endocrine side effects occurring in less than 1% of patients have included flushing and hot flushes.
Other side effects occurring in less than 1% of patients have included deafness, tinnitus, thirst, asthenia, edema, fatigue, feeling abnormal, gait disturbance, influenza-like symptoms, pain, breast pain, and gynecomastia. Altered laboratory parameters occurring in less than 1% of patients have included activated partial thromboplastin time prolonged, creatine increased, bicarbonate decreased, sodium increased, EEG abnormal, glucose increased, cholesterol increased, triglycerides increased, amylase increased, potassium increased, TSH increased, platelet count decreased, hematocrit decreased, hemoglobin decreased, mean corpuscular volume (MCV) increased, red blood cells (RBCs) decreased, creatinine increased, blood urea increased, blood urea nitrogen (BUN)/creatinine ratio increased, creatine phosphokinase (CPK) increased, alkaline phosphatase increased, lactate dehydrogenase (LDH) increased, prostate specific antigen (PSA) increased, urine output increased/decreased, lymphocyte count decreased, neutrophil count decreased, white blood cells (WBCs) increased/decreased, coagulation test abnormal, low density lipoprotein (LDL) increased, prothrombin time prolonged, urinary casts, and urine positive for white blood cells and protein.
Postmarketing side effects have included anaphylaxis and anaphylactic reaction.
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