NIKP-Levofloxacin Adverse Reactions

Approximately 10% of patients can be expected to experience adverse reactions. The reactions are usually graded as mild or moderate, are transient, and are generally restricted to the eye.
As the product contains benzalkonium chloride, contact eczema and/or irritation may be due to the active component or to this preservative.
The following undesirable effects assessed as definitely, probably or possibly related to treatment were reported during clinical trials and post-marketing experience with levofloxacin eye drops: Frequency categories are expressed as: Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000); Very rare(<1/10,000).
Immune system disorders: Rare: Extra-ocular allergic reactions, including skin rash.
Very rare: Anaphylaxis.
Nervous system disorders: Uncommon: Headache.
Eye disorders: Common: Ocular burning, decreased vision and mucous strand.
Uncommon: Lid matting, chemosis, conjunctival papillary reaction, lid oedema, ocular discomfort, ocular itching, ocular pain, conjunctival injection, conjunctival follicles, ocular dryness, lid erythema, and photophobia.
No corneal precipitates were observed in clinical studies.
Respiratory thoracic and mediastinal disorders: Uncommon: Rhinitis.
Very rare: Laryngeal oedema.
Ruptures of the shoulder, hand, Achilles, or other tendons that required surgical repair or resulted in prolonged disability have been reported in patients receiving systemic fluoroquinolones. Studies and post marketing experience with systemic quinolones indicate that a risk of these ruptures may be increased in patients receiving corticosteroids, especially geriatric patients and in tendons under high stress, including Achilles tendon (see Precautions).
Paediatric population: Frequency, type and severity of adverse reactions in children are expected to be the same as in adults.