The information given below is based on data from clinical studies in more than 8300 patients and on extensive post marketing experience.
Frequencies below are defined using the following convention: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1000 to <1/100), Rare (≥1/10000 to <1/1000), Very rare: (< 1/10000), Not known (Cannot be estimated from the available data).
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Infection and Infestation:
Uncommon: Fungal infection (and proliferation of other resistant microorganism).
Blood and lymphatic system disorders:
Uncommon: Leukopenia, Eosinophilia. Rare: Thrombocytopenia, Neutropenia. Very rare: Agranulocytosis. Not known: Pancytopenia, Agranulocytosis, Haemolytic anaemia.
Immune system disorders:
Very rare: Anaphylactic shock: Anaphylactic and anaphylactoid reactions may sometimes occur even after the first dose. Not known: Hypersensitivity.
Metabolism and nutrition disorders:
Uncommon: Anorexia. Very rare: Hypoglycemia, particularly in diabetic patients.
Uncommon: Insomnia, nervousness. Rare: Psychotic disorder, depression, confusional state, agitation, anxiety. Very rare: Psychotic reactions with self-endangering behaviour including suicidal ideation or acts, hallucination period.
Nervous system disorders:
Uncommon: Dizziness, headache, somnolence. Rare: Convulsion, tremor, paraesthesia. Very rare: sensory or sensorimotor peripheral neuropathy, dysgeusia including ageusia, parosmia including anosmia.
Very rare: Visual disturbance.
Ear and Labyrinth disorders:
Uncommon: Vertigo. Very rare: Hearing impaired. Not known: Tinnitus.
Rare: Tachycardia. Not Known: ventricular arrhythmia and torsades de pointes (reported predominantly in patients with risk factors for QT prolongation), ECG QT prolonged.
Common: Phlebitis. Rare: Hypotension.
Respiratory, thoracic and mediastinal disorders:
Rare: Bronchospasm, dyspnoea. Very rare: Pneumonitis allergic.
Common: Diarrhoea, nausea. Uncommon: Vomiting, abdominal pain, dyspepsia, flatulence, constipation. Rare: Diarrhoea - haemorrhagic which in very rare cases may be indicative of enterocolitis, including pseudomembranous colitis.
Common: Hepatic enzyme increased (ALT/AST, alkaline phosphatase, GGT). Uncommon: Blood bilirubin increased. Very rare: Hepatitis. Not known: Jaundice and severe liver injury, including cases with acute liver failure, have been reported with levofloxacin, primarily in patients with severe underlying diseases.
Skin and subcutaneous tissue disorders:
Uncommon: Rash, pruritus. Rare: Urticaria. Very rare: Angioneurotic oedema, photosensitivity reaction. Not Known: Toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, hyperhidrosis Mucocutaneous reactions may sometimes occur even after the first dose.
Musculoskeletal and Connective tissue disorders:
Rare: Tendon disorder, including tendinitis (e.g. Achilles tendon), arthralgia, myalgia. Very rare: Tendon rupture. This undesirable effect may occur within 48 hours of starting treatment and may be bilateral, muscular weakness which may be of special importance in patients with myasthenia gravis. Not Known: Rhabdomyolysis.
Renal and urinary disorders:
Uncommon: Blood creatinine increased. Very rare: Renal failure acute (e.g. due to nephritis interstitial).
General disorders and administration site conditions:
Common: Infusion site reaction. Uncommon: Asthenia. Very rare: Pyrexia. Not known: Pain (including pain in back, chest, and extremities).
Other undesirable effects which have been associated with fluoroquinolone administration include: extrapyramidal symptoms and other disorders of muscular coordination, hypersensitivity vasculitis, attacks of porphyria in patients with porphyria.