Moxifloxacin Hydrochloride (Page 6 of 14)

6.2 Postmarketing Experience

Table 4 below lists adverse reactions that have been identified during post-approval use of moxifloxacin. 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 4: Postmarketing Reports of Adverse Drug Reactions
System Organ Class Adverse Reactions
Blood and Lymphatic System Disorders Agranulocytosis
Pancytopenia [see Warnings and Precautions (5.7)]
Cardiac Disorders Ventricular tachyarrhythmias (including in very rare cases cardiac arrest and torsade de pointes, and usually in patients with concurrent severe underlying proarrhythmic conditions)
Ear and Labyrinth Disorders Hearing impairment, including deafness (reversible in majority of cases)
Eye Disorders Vision loss (especially in the course of CNS reactions, transient in majority of cases)
Hepatobiliary Disorders Hepatitis (predominantly cholestatic)
Hepatic failure (including fatal cases)
Acute hepatic necrosis [see Warnings and Precautions (5.7)]
Immune System Disorders Anaphylactic reaction
Anaphylactic shock
Angioedema (including laryngeal edema) [see Warnings and Precautions (5.7, 5.8)]
Musculoskeletal and Connective Tissue Disorders Tendon rupture [see Warnings and Precautions (5.2)]
Nervous System Disorders Altered coordination
Abnormal gait [see Warnings and Precautions (5.3)]
Myasthenia gravis (exacerbation of) [see Warnings and Precautions (5.5)]
Muscle weakness
Peripheral neuropathy (that may be irreversible), polyneuropathy [see Warnings and Precautions (5.3)]
Psychiatric Disorders Psychotic reaction (very rarely culminating in self-injurious behavior, such as suicidal ideation/thoughts or suicide attempts) [see Warnings and Precautions (5.4)]
Renal and Urinary Disorders Interstitial nephritis [see Warnings and Precautions (5.7)]
Respiratory, Thoracic and Mediastinal Disorders Allergic pneumonitis [see Warnings and Precautions (5.7)]
Skin and Subcutaneous Tissue Disorders Photosensitivity/phototoxicity reaction [see Warnings and Precautions (5.13)]
Stevens-Johnson syndrome
Toxic epidermal necrolysis [see Warnings and Precautions (5.7)]

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