.4)
Palpitations
Tachycardia
Atrial fibrillation
Angina pectoris
Ventricular tachyarrhythmias
Syncope (i.e., acute and short lasting loss of consciousness)
Unspecified arrhythmias
Torsade de Pointes (see section 4.4)
Cardiac arrest (see section 4.4)
Vascular disorders
Vasodilatation
Hypertension
Hypotension
Respiratory, thoracic and mediastinal disorders
Dyspnea (including asthmatic conditions)
Gastrointestinal disorders
Nausea
Vomiting
Gastrointestinal and abdominal pains
Diarrhoea
Decreased appetite and food intake
Constipation
Dyspepsia
Flatulence
Gastritis
Increased amylase
Dysphagia
Stomatitis
Antibiotic-associated colitis (incl. pseudo-membranous colitis, in very rare cases associated with life-threatening complications, see section 4.4)
Hepatobiliary disorders
Increase in transaminases
Hepatic impairment (incl. LDH increase)
Increased bilirubin
Increased gamma-glutamyl-transferase
Increase in blood alkaline phosphatase
Jaundice
Hepatitis (predominantly cholestatic)
Fulminant hepatitis potentially leading to life-threatening liver failure (incl. fatal cases, see section 4.4)
Skin and subcutaneous tissue disorders
Pruritus
Rash
Urticaria
Dry skin
Bullous skin reactions like Stevens-Johnson syndrome or toxic epidermal necrolysis (potentially life-threatening, see section 4.4)
Musculoskeletal andconnective tissue disorders
Arthralgia
Myalgia
Tendonitis (see section 4.4)
Muscle cramp
Muscle twitching
Muscle weakness
Tendon rupture (see section 4.4)
Arthritis
Muscle rigidity
Exacerbation of symptoms of myasthenia gravis (see section 4.4)
Renal and urinary disorders
Dehydration
Renal impairment (incl. increase in BUN and creatinine)
Renal failure (see section 4.4)
General disorders and administration site conditions
Injection and infusion site reactions
Feeling unwell (predominantly asthenia or fatigue)
Painful conditions (incl. pain in back, chest, pelvic and extremities)
Sweating
Infusion site (thrombo-) phlebitis
Oedema
The following undesirable effects have a higher frequency category in the subgroup of IV treated patients with or without subsequent oral therapy:
Common: Increased gamma-glutamyl-transferase
Uncommon: Ventricular tachyarrhythmias, hypotension, oedema, antibiotic-associated colitis (incl. pseudomembranous colitis, in very rare cases associated with life-threatening complications, see section 4.4), seizures incl. grand mal convulsions (see section 4.4), hallucination, renal impairment (incl. increase in BUN and creatinine), renal failure (see section 4.4)
There have been very rare cases of the following side effects reported following treatment with other fluoroquinolones, which might possibly also occur during treatment with moxifloxacin: hypernatrae