Levofloxacin (Page 7 of 17)

6.2 Postmarketing Experience


Table 6 lists adverse reactions that have been identified during post-approval use of levofloxacin. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Table 6: Postmarketing Reports Of Adverse Drug Reactions

System/Organ ClassSystem/Organ Class Adverse ReactionAdverse Reaction
System/Organ Class Adverse Reaction
Blood and Lymphatic System Disorders pancytopenia aplastic anemia leukopenia hemolytic anemia [see Warnings and Precautions ( 5.6) ] eosinophilia
Immune System Disorders hypersensitivity reactions, sometimes fatal including: anaphylactic/anaphylactoid reactions anaphylactic shock angioneurotic edema serum sickness [see Warnings and Precautions ( 5.6, 5.7) ]
Psychiatric Disorders psychosis paranoia isolated reports of suicidal ideation, suicide attempt and completed suicide [see Warnings and Precautions ( 5.4) ]
Nervous System Disorders Exacerbation of myasthenia gravis [see Warnings and Precautions ( 5.5) ]anosmia ageusia parosmia dysgeusia peripheral neuropathy (may be irreversible) [see Warnings and Precautions ( 5.3) ] isolated reports of encephalopathy abnormal electroencephalogram (EEG) dysphonia pseudotumor cerebri [see Warning and Precautions ( 5.4) ]
Eye Disorders Uveitis vision disturbance, including diplopia visual acuity reduced vision blurred scotoma
Ear and Labyrinth Disorders hypoacusis tinnitus
Cardiac Disorders isolated reports of torsade de pointes electrocardiogram QT prolonged [see Warnings and Precautions ( 5.11) ] tachycardia
Vascular Disorders vasodilatation
Respiratory, Thoracic and Mediastinal Disorders isolated reports of allergic pneumonitis [see Warnings and Precautions ( 5.6) ]
Hepatobiliary Disorders hepatic failure (including fatal cases) hepatitis jaundice [see Warnings and Precautions 5. 6, 5.8) ]
Skin and Subcutaneous Tissue Disorders bullous eruptions to include: Stevens-Johnson Syndrome toxic epidermal necrolysis Acute Generalized Exathematous Pustulosis (AGEP) fixed drug eruptions erythema multiforme [see Warnings and Precautions ( 5.6) ] photosensitivity/photoxicity reaction [see Warnings and Precautions ( 5.14) ] leukocytoclastic vasculitis
Musculoskeletal and Connective Tissue Disorders tendon rupture [see Warnings and Precautions ( 5.2) ] muscle injury, including rupture rhabdomyolysis
Renal and Urinary Disorders interstitial nephritis [see Warnings and Precautions ( 5.6) ]
General Disorders and Administration Site Conditions multi-organ failure pyrexia
Investigations prothrombin time prolonged international normalized ratio prolonged muscle enzymes increased

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