- Abnormal behavior
- Nervousness
- Memory impairment
-Sleep disorder
- Suicide
- Suicide attempt
- Suicidal ideation
Nervous system disorders
- Headache
- Dysgeusia
- Neuropathy
- Dizziness
- Hypoasthesia
- Parasthesia
- Tremor
- Somnolence
- Coma
- Cerebrovascular accident
- Convulsions
- Transient erectile dysfunction
-Encephalopathy
Eye disorders
- Visual disturbance
- Conjunctivitis
- Ischemic retinopathy
- Retinal artery thrombosis
- Optic neuropathy
- Retinal hemorrhage
- Retinal vein thrombosis
- Retinal exudates
- Retinopathy
- Papilledema
Ear and labyrinth disorders
- Vertigo
Cardiac disorders
- Arrhythmias4
- Palpitations
-Cyanosis
- Cardiorespiratory arrest
- Myocardial infarction
- Congestive heart failure
- Pulmonary edema
Vascular disorders
- Hypertension
- Hypotension
- Vasculitis
Respiratory, thoracic and mediastinal disorders
- Dyspnea
- Cough
Gastrointestinal disorders
- Diarrhea
- Vomiting
-Abdominal pain
- Nausea
-Dry mouth
- Pancreatitis
- Intestinal hypermotility
- Constipation
- Dyspepsia
- Flatulence
- Reactivation of peptic ulcer
-gastrointestinal bleeding (non life threatening)
Hepato-biliary disorders
- Hepatic failure
- Hepatitis
- Hepatic dysfunction
Skin and subcutaneous tissue disorders
- Alopecia5
- Sweating increased
- Psoriasis6
- Pruritus
- Rash
- Dry skin
- Epistaxis
- Mucosal dryness
- Rhinorrhea
Musculoskeletal, connective tissue and bone disorders
- Myalgia
- Arthralgia
- Systemic lupus
erythematosus
- Arthritis
Renal and urinary disorders
- Proteinuria
- Increased cell count in urine
- Acute renal failure7
- Renal impairment
General disorders and administration site conditions
-Flu like illness
-Appetite decreased
-Pyrexia
-Rigors
-Fatigue
- Chest pain
- Edema
-Injection site necrosis
-Injection site reaction
Investigations
- weight loss
-Increased ALT
-Increased transaminase
-Increased blood alkaline phosphatase
- Increased blood creatinine
-Increased blood urea
- Increased blood bilirubin
- Increased blood uric acid
-Increased blood LDH
1(including exacerbations of herpes labialis)
2In myelosuppressed patients, thrombocytopenia and decreased haemoglobin occurred more frequently. Recovery of severe haematological deviations to pre-treatment levels usually occurred within seven to ten days after discontinuing Roferon-A treatment.
3(e.g. urticaria, angioedema, bronchospasm and anaphylaxis)
4including atrioventricular block
5(reversible upon discontinuation; increased hair loss may continue for several weeks after end of treatment)
6exacerbation of, or provocation of psoriasis
7(mainly in cancer patients with renal dis