Side Effects

Side Effects of Febuxostat Tablets

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Stop taking this medicine and contact your doctor immediately or go to an emergency department nearby if the following rare (may affect up to 1 in 1,000 people) side effects occur, because a serious allergic reaction might follow: · anaphylactic reactions, drug hypersensitivity (see also section 2 “Warnings and precautions”) · potentially life-threatening skin rashes characterised by formation of blisters and shedding of the skin and inner surfaces of body cavities, e.g. mouth and genitals, painful ulcers in the mouth and/or genital areas, accompanied by fever, sore throat and fatigue (StevensJohnson Syndrome/ Toxic Epidermal Necrolysis), or by enlarged lymph nodes, liver enlargement, hepatitis (up to liver failure), raising of the white-cells count in the blood (drug reaction with eosinophilia and systemic symptoms-DRESS) (see section 2) · generalised skin rashes The common side effects (may affect up to 1 in 10 people) are: Page 5 of 7 · abnormal liver test results · diarrhoea · headache · rash (including various types of rash, please see below under “uncommon” and “rare” sections) · nausea · increase in gout symptoms · localised swelling due to retention of fluids in tissues (oedema) Other side effects which are not mentioned above are listed below. Uncommon side effects (may affect up to 1 in 100 people) are: · decreased appetite, change in blood sugar levels (diabetes) of which a symptom may be excessive thirst, increased blood fat levels, weight increase · loss of sex drive · difficulty in sleeping, sleepiness · dizziness, numbness, tingling, reduced or altered sensation (hypoesthesia, hemiparesis or paraesthesia), altered sense of taste, diminished sense of smell (hyposmia) · abnormal ECG heart tracing, irregular or rapid heartbeats, feeling your heart beat (palpitation) · hot flushes or flushing (e.g. redness of the face or neck), increased blood pressure, bleeding (hemorrhage, seen only in patients taking chemotherapy for blood disorders) · cough, shortness of breath, chest discomfort or pain, inflammation of nasal passage and/or throat (upper respiratory tract infection), bronchitis · dry mouth, abdominal pain/discomfort or wind, heartburn/indigestion, constipation, more frequent passing of stools, vomiting, stomach discomfort · itching, hives, skin inflammation, skin discoloration, small red or purple spots on the skin, small, flat red spots on the skin, flat, red area on the skin that is covered with small confluent bumps, rash, areas of redness and spots on the skin, other type of skin conditions · muscle cramp, muscle weakness, pain/ache in muscles/joints, bursitis or arthritis (inflammation of joints usually accompanied by pain, swelling and/or stiffness), pain in extremity, back pain, muscle spasm · blood in the urine, abnormal frequent urination, abnormal urine tests (increased level of proteins in the urine), a reduction in the ability of the kidneys to function properly · fatigue, chest pain, chest discomfort · stones in the gallbladder or in bile ducts (cholelithiasis) · increase in blood thyroid stimulating hormone (TSH) level · changes in blood chemistry or amount of blood cells or platelets (abnormal blood test results) · kidney stones · erectile difficulties Rare side effects (may affect up to 1 in 1,000 people) are: · muscle damage, a condition which on rare occasions can be serious. It may cause muscle problems and particularly, if at the same time, you feel unwell or have a high temperature it may be caused by an abnormal muscle breakdown. Contact your doctor immediately if you experience muscle pain, tenderness or weakness · severe swelling of the deeper layers of the skin, especially around the lips, eyes, genitals, hands, feet or tongue, with possible sudden difficult breathing · high fever in combination with measles-like skin rash, enlarged lymph nodes, liver enlargement, hepatitis (up to liver failure), raising of the white-cells count in the blood Page 6 of 7 (leukocytosis, with or without eosinophilia) · reddening of the skin (erythema), rash in various types (e.g. itchy, with white spots, with blisters, with blisters containing pus, with shedding of the skin, measles-like rash), widespread erythema, necrosis, and bullous detachment of the epidermis and mucous membranes, resulting in exfoliation and possible sepsis (Stevens-Johnson Syndrome/Toxic epidermal necrolysis) · nervousness · feeling thirsty · ringing in the ears · blurred vision, change in vision · hair loss · mouth ulceration · inflammation of the pancreas: common symptoms are abdominal pain, nausea and vomiting · increased sweating · weight decrease, increased appetite, uncontrolled loss of appetite (anorexia) · muscle and/or joint stiffness · abnormally low blood cell counts (white or red blood cells or platelets) · urgent need to urinate · changes or decrease in urine amount due to inflammation in the kidneys (tubulointerstitial nephritis) · inflammation of the liver (hepatitis) · yellowing of the skin (jaundice) · liver damage · increased level of creatine phosphokinase in blood (an indicator of muscle damage) Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet