Like all medicines, Pegasys can cause side effects, although not eveybody gets them.
Some people get depressed when taking Pegasys alone or in combination treatment with ribavirin, and in some cases people have had suicidal thoughts or aggressive behaviour (sometimes directed against others such as thoughts about threatening the life of the others). Some patients have actually committed suicide. Be sure to seek emergency care if you notice that you are becoming depressed or have suicidal thoughts or change in your behaviour. You may want to consider asking a family member or close friend to help you stay alert to signs of depression or changes in your behaviour.
During treatment your doctor will take blood samples regularly to check for changes in your white blood cells (cells that fight infection), red blood cells (cells that carry oxygen), platelets (blood clotting cells), liver function or changes in other laboratory values.
Tell your doctor immediately if you notice any of the following side effects: severe chest pain; persistent cough; irregular heartbeat; trouble breathing; confusion; depression; severe stomach pain; blood in stool (or black, tarry stools); severe nosebleed; fever or chills; problems with your eyesight. These side effects can be serious and you may need urgent medical attention.
Very common side effects with the combination of Pegasys and ribavirin (occurring in more than 10 out of 100 patients) are:
Metabolic disorders: Loss of appetite
Psychiatric disorders: feeling depressed (feeling low, feeling bad about yourself or feeling hopeless), anxiety, inability to sleep
Nervous system disorders: Headache, difficulty concentrating and dizziness
Respiratory disorders: cough, shortness of breath
Gastrointestinal disorders: diarrhoea, nausea, abdominal pain
Skin disorders: loss of hair, and skin reactions (including itching, dermatitis and dry skin). Musculoskeletal disorders: pain in joints and muscles
General disorders: fever, weakness, tiredness, shaking, chills, pain, injection site irritation and irritability (getting easily upset)
Common side effects with the combination of Pegasys and ribavirin occurring in more than 1 out of 100 patients:
Infections: Fungal, viral and bacterial infections. Upper respiratory infection, bronchitis, fungal infection of the mouth and herpes (a common recurring viral infection affecting the lips, mouth) Blood disorders: Low platelet count (affecting the clotting ability), anaemia (low red cell count) and enlarged lymph glands.
Endocrine disorders: overactive and underactive thyroid gland
Psychiatric disorders: Mood /emotion changes, aggression, nervousness, decreased sexual desire Nervous system disorders: Poor memory, fainting, decreased muscle strength, migraine, numbness, tingling, burning sensation, tremor, changes in the sense of taste, nightmares, sleepiness Eye Disorders: Blurry vision, eye pain, eye inflammation and dry eyes.
Ear disorders: Sensation of room spinning, ear pain
Cardiac disorders: Rapid heart rate, pulsation of the heart beats, swelling in the extremities. Vascular disorders: Flushing
Respiratory disorders: shortness of breath with activity, nose bleeds, nose and throat inflammation, infections of the nose and sinuses (air-filled spaces found in the bones of the head and face), runny nose, sore throat.
Gastrointestinal disorders: Vomiting, indigestion, difficulty swallowing, mouth ulceration, bleeding gums, inflammation of tongue and mouth, flatulence (excess amount of air or gases), dry mouth and loss of weight
Skin disorders: Rash, increased sweating, psoriasis, hives, eczema, sensitivity to sunlight, night sweats Musculoskeletal disorders: Back pain, joint inflammation, muscle weakness, bone pain, neck pain, muscle pain, muscle cramps
Reproductive system disorders: Impotence (inability to maintain an erection)
General disorders: Chest pain, flu-like illness, malaise (not feeling well), lethargy, hot flushes, thirst
Uncommon side effects with the combination of Pegasys and ribavirin occurring in more than 1 out of 1000 patients:
Infections: Lung infection, skin infections
Neoplasms benign and malignant disorders: Liver tumour
Immune disorders: sarcoidosis (areas of inflamed tissue occurring throughout the body), inflammation of the thyroid
Endocrine disorders: Diabetes (high blood sugar)
Metabolic disorders: Dehydration
Psychiatric disorders: Thoughts of suicide, hallucinations (severe problems with personality and deterioration in normal social functioning)
Nervous system disorders: Peripheral neuropathy (disorder of the nerves affecting the extremities) Eye disorders: Bleeding in the retina (back of the eye)
Ear disorders: Hearing loss
Vascular disorder: High blood pressure
Respiratory diosorders: Wheezing
Gastrointestinal disorders: gastrointestinal bleeding
Liver disorders: Poor functioning of the liver
Rare side effects with the combination of Pegasys and ribavirin occurring in more than 1 in 10,000 patients:
Infections: Infection of the heart, infection of the external ear
Blood disorders: severe reduction in red blood cells, white blood cells and platelet
Immune system disorders: Severe allergic reaction, systemic lupus erythematosus (an illness where the body attacks its own cells), rheumatoid arthritis (an autoimmune disease)
Endocrine disorders: Diabetic ketoacidosis, a complication of uncontrolled diabetes Psychiatric disorders: Suicide, psychotic disorders (severe problems with personality and deterioration in normal social functioning)
Nervous system disorders: Coma (a deep prolonged unconsciousness), seizures, facial palsy (weakness of the facial muscle)
Eye disorders: Inflammation and swelling of the optic nerve, inflammation of the retina, ulceration of the cornea
Cardiac disorders: Heart attack, heart failure, heart pain, rapid heart rhythm, rhythm disorders or inflammation of the lining of the heart and cardiac muscle.
Vascular disorders: Bleeding in the brain and inflammation in the vessels.
Respiratory disorders: Interstitial pneumonia (inflammation of the lungs including fatal outcome), blood clots in the lung
Gastrointestinal disorders: stomach ulcer, inflammation of the pancreas
Liver disorders: Liver failure, bile duct inflammation, fatty liver
Musculoskeletal disorders: Inflammation of the muscles
Renal disorders: renal failure
Injury or poisoning: Substance overdose
Very rare side effects with the combination of Pegasys and ribavirin occurring in less than 1 in 10,000 patients:
Blood disorders: aplastic anaemia (failure of the bone marrow to produce red blood cells, white blood cells and platelets). Pure red cell aplasia (a severe form of anemia where red blood cell production is decreased or stopped) has been very rarely reported; it can result in symptoms such as feeling very tired with no energy.
Immune System disorders: Idiopathic (or thrombotic) thrombocytopenic purpura (increased bruising, bleeding, decreased platelets, anaemia and extreme weakness)
Eye disorders: Loss of vision
Skin disorders: Toxic epidermal necrolysis/Stevens Johnson Syndrome/ erythema multiforme (a spectrum of rashes with varying degrees of severity including death which may be associated with blisters in the mouth, nose, eyes and other mucosal membranes and sloughing of the affected area of the skin), angioedema (swelling in the skin and mucosa).
Adverse events with unknown frequency:
Nervous system: Stroke
Eye disorders: Rare form of retinal detachment with fluid in the retina.
Gastrointestinal disorders: Ischaemic colitis (insufficient blood supply to the bowels). Musculoskeletal disorders: Serious muscle damage and pain.
When Pegasys is used alone in hepatitis B or C patients, some of these effects are less likely to occur. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.