Doxorubicin Hydrochloride Injection

Possible side effects
Doxorubicin can cause side effects, although not everybody gets them.

Please contact your doctor or nurse immediately in case:

• you feel dizzy
• feverish
• short of breath with a tight chest or throat or have an itchy rash
• This may be a type of allergic reaction which can be very serious
  you feel tired and lethargic. This may be sign of anemia (a low red blood cell count)
• you have fever or other symptoms of infection. This may be sign of low white blood cell counts you bruise or bleed more easily. This may be sign of low platelet count in your blood.

Very common side effects (more than 1 in 10 patients)

• feeling sick
• being sick
• abdominal pain
• digestive disorders
• diarrhoea
• inflammation of the mucous membranes e.g. in the mouth or esophagus
• hair loss (normally reversible)
• skin redness
• sensitivity of skin to artificial or natural light (photosensitivity)
• red colouration of the urine, for one or two days after administration.
• This is normal and nothing to worry about
  bone-marrow suppression (deficiency in blood cells) including reduction in number of white blood cells (causing infection), blood platelets (causing bleeding and bruises) and red blood cells (anaemia; so the skin can be pale and weakness may occur, or shortness of breath)
  severe heart complications (cardiotoxicity), like damage to the heart muscle or fast, slow or irregular pulse.
• Effects can appear shortly after the treatment is started or be observed several years later fever.

Common side effects (more than 1 in 100 patients, but less than 1 in 10 patients)

• bacterial infection
• bacterial infection in the blood
• cardiac arrhythmias (irregular heart beat, rapid heart rate, decreased heart rate)
• reduced amount of blood pumped through the heart
• deterioration of the function of the heart muscle (cardiomyopathy) that can be life threatening
• bleeding (haemorrhage)
• eating disorder (anorexia)
• local allergic reaction of the field of radiation itching
• difficult or painful urination
• bladder inflammation following instillation in the bladder
• sometimes with irritation in the bladder
• blood in the urine
• painful urination
• more frequent urination or decreased urine

Uncommon side effects (more than 1 in 1,000 patients, but less than 1 in 100 patients)

• acute blood cancer (certain types of leukaemia)
• inflammation of a vein
• bleeding in the stomach or intestines
• ulcers in the mucous membranes of the mouth, pharynx, esophagus, stomach and the intestines
• ulcers and possible death of cells/tissues of the colon when Doxorubicin is given in combination with the medicinal product cytarabine
  dehydration.

Rare side effects (more than 1 in 10,000 patients, but less than 1 in 1,000 patients)

• inflammation of the outermost layer of the eye (conjunctivitis)
  hives
• skin rash and redness
• darkened areas of skin and nails
• loosening of the nails (onycholysis)
• severe allergic reactions with or without shock, including skin rash, itching, fever and chills (anaphylactic reactions)
• shivering
• dizziness

Very rare side effects (less than 1 in 10,000 patients)

• flushing of the face
• changes in the heart function (unspecified ECG changes), isolated cases of life-threatening irregular heart beat (arrhythmias), heart failure, inflammation of the pericardium / myocardium, loss of nerve impulses in the heart
• clot formation in a blood vessel
• discoloration (pigmentation) of the oral mucosa
• swelling and numbness of the hands and feet (acral erythema)
• blistering
• tissue damage especially of the hands and feet
• causing redness
• swelling, blisters, tingling or burning sensation where leakage of
  abnormally high uric acid levels in the blood
• absence of menstrual period
• fertility problems in men (reduction or absence of active sperm)

Side effects where frequency is not known (cannot be estimated from the available data)

• increased tear production
• coughing or difficulty in breathing because of sudden narrowing of airways
• lung inflammation
• liver toxicity, which sometimes can progress to permanent damage of liver tissue (cirrhosis)
• transient increase of liver enzymes
  fat
• bald or crusty patches of skin (actinin keratosis)
  severe pain and swelling in the joints
• weakness
• radiation damage (on the skin, lungs, throat, esophagus, stomach and intestinal mucosa, heart) already healing, may reappear following administration of doxorubicin