Like all medicines, this medicine can cause side effects, although not everybody gets them.
Most side effects are likely to be minor and temporary. However, some may be serious and need medical attention.
Serious side effects: Voratex intake should be stopped and immediate medical attention is necessary in case of: Rash; Jaundice; Changes in blood tests of liver function; Pancreatitis.
Other side effects: Very common (may affect more than 1 in 10 people): Visual impairment (change in vision including blurred vision, visual colour alterations, abnormal intolerance to visual perception of light, colour blindness, eye disorder, halo vision, night blindness, swinging vision, seeing sparks, visual aura, visual acuity reduced, visual brightness, loss of part of the usual field of vision, spots before the eyes); Fever; Rash; Nausea, vomiting, diarrhoea; Headache; Swelling of the extremities; Stomach pains; Breathing difficulties; Elevated liver enzymes.
Common (may affect up to 1 in 10 people): Inflammation of the sinuses, inflammation of the gums, chills, weakness; Low numbers of some types, including severe, of red (sometimes immune-related) and/or white blood cells (sometimes with fever), low numbers of platelets; Low blood sugar, low blood potassium, low blood sodium; Anxiety, depression, confusion, agitation, inability to sleep, hallucinations; Seizures, tremors or uncontrolled muscle movements, tingling or abnormal skin sensations, increase in muscle tone, sleepiness, dizziness; Bleeding in the eye; Heart rhythm problems including very fast heartbeat, very slow heartbeat, fainting; Low blood pressure, inflammation of a vein (which may be associated with the formation of a blood clot); Acute breathing difficulty, chest pain, swelling of the face (mouth, lips and around eyes), fluid accumulation in the lungs; Constipation, indigestion, inflammation of the lips; Jaundice, inflammation of the liver and liver injury; Skin rashes which may lead to severe blistering and peeling of the skin characterized by a flat, red area on the skin that is covered with small confluent bumps, redness of the skin; Itchiness; Hair loss; Back pain; Kidney failure, blood in the urine, changes in kidney function tests.
Uncommon (may affect up to 1 in 100 people): Flu-like symptoms, irritation and inflammation of the gastrointestinal tract, inflammation of the gastrointestinal tract causing antibiotic-associated diarrhoea, inflammation of the lymphatic vessels; Inflammation of the thin tissue that lines the inner wall of the abdomen and covers the abdominal organ; Enlarged lymph glands (sometimes painful), failure of blood marrow, increased eosinophil; Depressed function of the adrenal gland, underactive thyroid gland; Abnormal brain function, Parkinson-like symptoms, nerve injury resulting in numbness, pain, tingling or burning in the hands or feet; Problems with balance or coordination; Swelling of the brain; Double vision, serious conditions of the eye including pain and inflammation of the eyes and eyelids, abnormal eye movement, damage to the optic nerve resulting in vision impairment, optic disc swelling; Decreased sensitivity to touch; Abnormal sense of taste; Hearing difficulties, ringing in the ears, vertigo; Inflammation of certain internal organs (pancreas and duodenum), swelling and inflammation of the tongue; Enlarged liver, liver failure, gallbladder disease, gallstones; Joint inflammation, inflammation of the veins under the skin (which may be associated with the formation of a blood clot); Inflammation of the kidney, proteins in the urine, damage to the kidney; Very fast heart rate or skipped heartbeats, sometimes with erratic electrical impulses; Abnormal electrocardiogram (ECG); Blood cholesterol increased, blood urea increased; Allergic skin reactions (sometimes severe), including life-threatening skin condition that causes painful blisters and sores of the skin and mucous membranes, especially in the mouth, inflammation of the skin, hives, sunburn or severe skin reaction following exposure to light or sun, skin redness and irritation, red or purple discoloration of the skin which may be caused by low platelet count, eczema; Infusion site reaction; Allergic reaction or exaggerated immune response.
Rare (may affect up to 1 in 1000 people): Overactive thyroid gland; Deterioration of brain function that is a serious complication of liver disease; Loss of most fibres in the optic nerve, clouding of the cornea, involuntary movement of the eye; Bullous photosensitivity; Disorder in which the body's immune system attacks part of the peripheral nervous system; Heart rhythm or conduction problems (sometimes life-threatening); Life-threatening allergic reaction; Disorder of blood clotting system; Allergic skin reactions (sometimes severe), including rapid swelling (oedema) of the dermis, subcutaneous tissue, mucosa and submucosal tissues, itchy or sore patches of thick, red skin with silvery scales of skin, irritation of the skin and mucous membranes, life-threatening skin condition that causes large portions of the epidermis to detach from the layers of skin below; Small dry scaly skin patches, sometimes thick with spikes or 'horns'.
Side effects with frequency not known: Freckles and pigmented spots.
Other significant side effects whose frequency is not known, but should be reported immediately: Skin cancer; Inflammation of the tissue surrounding the bone; Red, scaly patches or ring-shaped skin lesions that may be a symptom of cutaneous lupus erythematosus.
As Voratex has been known to affect the liver and the kidney, liver and kidney function should be monitored. Any stomach pains or stools with different consistency should be reported.
There have been reports of skin cancer in patients treated with Voratex for long periods of time.
Sunburn or severe skin reaction following exposure to light or sun was experienced more frequently in children. If skin disorders develop, patients may be referred to a dermatologist. Elevated liver enzymes were also observed more frequently in children.
Reporting of side effects: Side effects should be reported. This includes any possible side effects not previously listed.