Spedifen Side Effects

Blood and lymphatic system disorders: Rare: Haematological effects such as agranulocytosis, thrombocytopenia, neutropenia, aplastic anaemia, haemolytic anaemia.
Isolated cases: Anaemia.
Immune system disorders: Uncommon: Allergic reaction.
Rare: Lupus erythematosus syndrome, meningitis aseptic in patients suffering from an autoimmune disease, such as Lupus erythematosus, autoimmune haemolytic anaemia, anaphylaxis.
Isolated cases: Anaphylactic shock.
Psychiatric disorders: Uncommon to common: Depression, anxiety, confusional state.
Very rare: Psychotic state.
Nervous system disorders: Common: Headache, dizziness.
Uncommon to common: Central nervous system side effects such as impaired responsiveness (especially in association with alcohol), sleepiness.
Rare: Paraesthesia.
Eye disorders: Uncommon to common: Visual disturbance.
Visual disturbances are usually reversible when treatment is discontinued.
Rare: Toxic amblyopia, optic neuritis.
Isolated cases: Papilloedema.
Ear and labyrinth disorders: Uncommon to common: Ear disorder, hardness of hearing.
Cardiac disorders: Isolated cases: Cardiac failure.
Vascular disorders: Isolated cases: Arterial thrombosis, hypertension, hypotension.
Respiratory, thoracic and mediastinal disorders: Uncommon: Bronchospasm, asthma, aggravated asthma, dyspnoea.
Rare: Risk of acute pulmonary oedema in patients with cardiac insufficiency.
Isolated cases: Throat irritation.
Gastrointestinal disorders: Very common: Dyspepsia, diarrhoea.
Common: Gastrointestinal side effects such as nausea, abdominal fullness, heartburn, abdominal pain, anorexia, constipation, flatulence, vomiting, gastritis erosive, rectal blood loss (resulting in anaemia).
Uncommon: Peptic ulcer, gastrointestinal haemorrhage, melaena, gastritis.
Rare: Ulcerations or perforations in the gastrointestinal tract with haemorrhage, haematemesis, ulcerative stomatitis, colitis aggravated, Crohn's aggravated.
Hepatobiliary disorders: Rare: Liver disorder, liver failure.
Isolated cases: Liver injury, hepatitis, jaundice.
Skin and sub-cutaneous tissue disorders: Common: Hypersensitivity reactions such as urticaria, purpura, pruritus, exanthem.
Uncommon: Angioedema.
Very rare: Bullous reaction, erythema multiforme, dermatitis exfoliative, Stevens-Johnson syndrome, toxic epidermal necrolysis, photosensitivity reaction.
Isolated cases: Aggravation of skin reactions, Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), acute generalised exanthematous pustulosis (AGEP).
Renal and urinary disorders: Rare: Haematuria, renal papillary necrosis, nephritis interstitial, kidney dysfunction with oedema.
Very rare: Acute renal failure.
General disorders and administration site conditions: Isolated cases: Oedema.
Investigations: Rare: Liver function test abnormal.
Isolated cases: Renal function test abnormal.