4.8 Undesirable effects
Adverse reactions observed in clinical trials with moxifloxacin 400 mg daily administered by the intravenous or oral route (intravenous only, sequential [IV/oral] and oral administration) sorted by frequencies are listed below:

Apart from nausea and diarrhoea all adverse reactions were observed at frequencies below 3%.

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. Frequencies are defined 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)

System Organ Class (MedDRA)
 Common
 Uncommon
 Rare
 Very Rare
 
Infections and infestations
 Superinfections due to resistant bacteria or fungi e.g. oral and vaginal candidiasis
      
Blood and lymphatic system disorders
   Anaemia

Leucopenia(s)

Neutropenia

Thrombocytopenia

Thrombocythemia

Blood eosinophilia

Prothrombin time prolonged/ INR increased
   Prothrombin level increased/ INR decreased

Agranulocytosis
 
Immune system disorders
   Allergic reaction (see section 4.4)
 Anaphylaxis incl. very rarely life-threatening shock (see section 4.4)

Allergic oedema/ angiooedema (incl. laryngeal oedema, potentially life-threatening, see section 4.4)
  
Metabolism and nutrition disorders
   Hyperlipidemia
 Hyperglycemia

Hyperuricemia
  
Psychiatric disorders
   Anxiety reactions

Psychomotor hyperactivity/ agitation
 Emotional lability

Depression (in very rare cases potentially culminating in self-injurious behaviour, such as suicidal ideations/ thoughts, or suicide attempts, see section 4.4)

Hallucination
 Depersonalization

Psychotic reactions (potentially culminating in self-injurious behaviour, such as suicidal ideations/ thoughts, or suicide attempts, see section 4.4)
 
Nervous system disorders
 Headache

Dizziness
 Par- and Dysaesthesia

Taste disorders (incl. ageusia in very rare cases)

Confusion and disorientation

Sleep disorders (predominantly insomnia)

Tremor

Vertigo

Somnolence
 Hypoaesthesia

Smell disorders (incl. anosmia)

Abnormal dreams

Disturbed coordination (incl. gait disturbances, esp. due to dizziness or vertigo)

Seizures incl. grand mal convulsions (see section 4.4)

Disturbed attention

Speech disorders

Amnesia

Peripheral neuropathy and polyneuropathy
 Hyperaesthesia
 
Eye disorders
   Visual disturbances incl. diplopia and blurred vision (especially in the course of CNS reactions, see section 4.4)
   Transient loss of vision (especially in the course of CNS reactions, see sections 4.4 and 4.7)
 
Ear and labyrinth disorders
     Tinnitus

Hearing impairment incl. deafness (usually reversible)
  
Cardiac disorders
 QT prolongation in patients with hypokalaemia (see sections 4.3 and 4.4)
 QT prolongation (see section 4