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.
| 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) | |
| Jaundice | |
| 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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