Side Effects

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The side effects listed below were observed in arthritis patients who took Celebrex. Side effects marked with an asterisk (*) are listed below at the higher frequencies that occurred in patients who took Celebrex to prevent colon polyps. Patients in these studies took Celebrex at high doses and for a long duration. If any of the following happen, stop taking Celebrex and tell your doctor immediately: If you have: – an allergic reaction such as skin rash, swelling of the face, wheezing or difficulty breathing – heart problems such as pain in the chest Page 6 of 10 – severe stomach pain or any sign of bleeding in the stomach or intestines, such as passing black or bloodstained stools, or vomiting blood – a skin reaction such as rash, blistering or peeling of the skin – liver failure (symptoms may include nausea (feeling sick), diarrhoea, jaundice (your skin or the whites of your eyes look yellow)). Very common: may affect more than 1 in 10 people • High blood pressure, including worsening of existing high blood pressure * Common: may affect up to 1 in 10 people • Heart attack* • Fluid build up with swollen ankles, legs and/or hands • Urinary infections • Shortness of breath*, sinusitis (sinus inflammation, sinus infection, blocked or painful sinuses), blocked or runny nose, sore throat, coughs, colds, flu-like symptoms • Dizziness, difficulty sleeping • Vomiting*, stomach ache, diarrhoea, indigestion, wind • Rash, itching • Muscle stiffness • Difficulty swallowing* • Headache • Nausea (feeling sick) • Painful joints • Worsening of existing allergies • Accidental injury Uncommon: may affect up to 1 in 100 people • Stroke* • Heart failure, palpitations (awareness of heart beat), fast heart rate • Abnormalities in liver-related blood tests • Abnormalities in kidney-related blood tests • Anaemia (changes in red blood cells that can cause fatigue and breathlessness) • Anxiety, depression, tiredness, drowsiness, tingling sensations (pins and needles) • High levels of potassium in blood test results(can cause nausea (feeling sick), fatigue, muscle weakness or palpitations) • Impaired or blurred vision, ringing in the ears, mouth pain and sores, difficulty hearing* • Constipation, burping, stomach inflammation (indigestion, stomach ache or vomiting), worsening of inflammation of the stomach or intestine • Leg cramps • Raised itchy rash (hives) • Eye inflammation • Difficulty breathing • Skin discolouration (bruising) • Chest pain (generalised pain not related to the heart) • Face swelling Page 7 of 10 Rare: may affect up to 1 in 1,000 people • Ulcers (bleeding) in the stomach, gullet or intestines; or rupture of the intestine (can cause stomach ache, fever, nausea, vomiting, intestinal blockage), dark or black stools, inflammation of the pancreas (can lead to stomach pain), inflammation of the gullet (oesophagus) • Low levels of sodium in the blood (a condition known as hyponatraemia) • Reduced number of white blood cells (which help to protect the body from infection) or blood platelets (increased chance of bleeding or bruising) • Difficulty coordinating muscular movements • Feeling confused, changes in the way things taste • Increased sensitivity to light • Loss of hair • Hallucinations • Bleeding in the eye • Acute reaction that may lead to lung inflammation • Irregular heartbeat • Flushing • Blood clot in the blood vessels in the lungs. Symptoms may include sudden breathlessness, sharp pains when you breathe or collapse • Bleeding of the stomach or intestines (can lead to bloody stools or vomiting), inflammation of the intestine or colon • Severe liver inflammation (hepatitis). Symptoms may include nausea (feeling sick), diarrhoea, jaundice (yellow discolouration of the skin or eyes), dark urine, pale stools, bleeding easily, itching or chills • Acute kidney failure • Menstrual disturbances • Swelling of the face, lips, mouth, tongue or throat, or difficulty swallowing Very rare: may affect up to 1 in 10,000 people • Serious allergic reactions (including potentially fatal anaphylactic shock) • Serious skin conditions such as Stevens-Johnson syndrome, exfoliative dermatitis and toxic epidermal necrolysis (can cause rash, blistering or peeling of the skin) and acute generalised exanthematous pustulosis (symptoms include the skin becoming red with swollen areas covered in numerous small pustules) • A delayed allergic reaction with possible symptoms such as rash, swelling of the face, fever, swollen glands, and abnormal test results (e.g., liver, blood cell (eosinophilia, a type of raised white blood cell count)) • Bleeding within the brain causing death • Meningitis (inflammation of the membrane around the brain and spinal cord) • Liver failure, liver damage and severe liver inflammation (fulminant hepatitis) (sometimes fatal or requiring liver transplant). Symptoms may include nausea (feeling sick), diarrhoea, jaundice (yellow discolouration of the skin or eyes), dark urine, pale stools, bleeding easily, itching or chills • Liver problems (such as cholestasis and cholestatic hepatitis, which may be accompanied by symptoms such as discoloured stools, nausea and yellowing of the skin or eyes) Page 8 of 10 • Inflammation of the kidneys and other kidney problems (such as nephrotic syndrome and minimal change disease, which may be accompanied by symptoms such as water retention (oedema), foamy urine, fatigue and a loss of appetite) • Worsening of epilepsy (possible more frequent and/or severe seizures) • Blockage of an artery or vein in the eye leading to partial or complete loss of vision • Inflamed blood vessels (can cause fever, aches, purple blotches on the skin) • A reduction in the number of red and white blood cells and platelets (may cause tiredness, easy bruising, frequent nose bleeds and increased risk of infections) • Muscle pain and weakness • Impaired sense of smell • Loss of taste Not known: frequency cannot be estimated from the available data • Decreased fertility in females, which is usually reversible on discontinuation of the medicine In clinical studies not associated with arthritis or other arthritic conditions, where Celebrex was taken at doses of 400 mg per day for up to 3 years, the following additional side effects have been observed: Common: may affect up to 1 in 10 people • Heart problems: angina (chest pain) • Stomach problems: irritable bowel syndrome (can include stomach ache, diarrhoea, indigestion, wind) • Kidney stones (which may lead to stomach or back pain, blood in urine), difficulty passing urine • Weight gain Uncommon: may affect up to 1 in 100 people • Deep vein thrombosis (blood clot usually in the leg, which may cause pain, swelling or redness of the calf or breathing problems) • Stomach problems: stomach infection (which can cause irritation and ulcers of the stomach and intestines) • Lower limb fracture • Shingles, skin infection, eczema (dry itchy rash), pneumonia (chest infection (possible cough, fever, difficulty breathing)) • Floaters in the eye causing blurred or impaired vision, vertigo due to inner ear troubles, sore, inflamed or bleeding gums, mouth sores • Excessive urination at night, bleeding from piles/ haemorrhoids, frequent bowel movements • Fatty lumps in skin or elsewhere, ganglion cyst (harmless swellings on or around joints and tendons in the hand or foot), difficulty speaking, abnormal or very heavy bleeding from the vagina, breast pain • High levels of sodium in blood test results Reporting of side effects Page 9 of 10 If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine. United Kingdom Yellow Card Scheme website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.