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Avelox® Adverse Events
Adverse drug reactions (ADRs) based on all clinical studies with Avelox® 400 mg (per oral (PO) and sequential therapy), are listed below. ADRs listed under the "common" category were observed with a frequency below 3% with the exception of nausea and diarrhea. ADRs derived from post marketing reports (status: June 2008) are printed in bold italic.
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Clinical Description
| Common >1% to <10% | Uncommon >0.1% to <1% | Rare >0.01% to <0.1% | Very Rare <0.01% |
|---|
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Clinical Description
| Common >1% to <10% | Uncommon >0.1% to <1% | Rare >0.01% to <0.1% | Very Rare <0.01% |
|---|---|---|---|---|
| INFECTIONS AND INFESTATIONS Show | ||||
Antibiotic induced superinfections |
Mycotic superinfections |
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| BLOOD AND THE LYMPHATIC SYSTEM DISORDERS Show | ||||
Changes in blood cell counts |
Anaemia Leukopenia(s) Neutropenia Thrombocytopenia Thrombocythemia |
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Changes in coagulation |
Prothrombin time prolonged / INR increased |
Thromboplastin level abnormal |
Prothrombin level increased / INR decreased Prothrombin level / INR abnormal |
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| IMMUNE SYSTEM DISORDERS Show | ||||
Acute hypersensitivity reactions |
Allergic reaction Pruritus Rash Urticaria Blood eosinophilia |
Anaphylactic / anaphylactoid reaction Allergic oedema / angioedema (incl. laryngeal oedema, potentially life threatening) |
Anaphylactic / anaphylactoid shock (potentially life threatening) |
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| METABOLISM AND NUTRITION DISORDERS Show | ||||
Changes in Laboratory Parameters |
Hyperlipidaemia |
Hyperglycaemia Hyperuricaemia |
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| PSYCHIATRIC DISORDERS Show | ||||
Behavioural disturbances |
Anxiety reactions Psychomotor hyperactivity/ agitation |
Emotional lability Depression (in very rare cases potentially culminating in self endangering behaviour) Hallucinations |
Depersonalisation Psychotic reactions (potentially culminating in self-endangering behaviour) |
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| NERVOUS SYSTEM DISORDERS Show | ||||
Unspecific altered peripheral perception |
Par- and Dysesthesia |
Hypoesthesia |
Hyperesthesia |
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Smell and taste disorder |
Taste disorders (incl. ageusia in very rare cases) |
Smell disorders (incl. anosmia) |
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Increased neurological activities |
Headache Dizziness |
Confusion and disorientation Sleep disorders Tremor Vertigo |
Abnormal dreams Disturbed coordination (incl. gait disturbances, esp. due to dizziness or vertigo; in very rare cases leading to fall with injuries, esp. in elderly) Seizures of various clinical manifestations (incl. grand mal convulsions) |
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Decreased neurological activities |
Somnolence |
Disturbed attention Speech disorders Amnesia |
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| EYE DISORDERS Show | ||||
Eye Disorders |
Visual disturbances (especially in the course of CNS reactions) |
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| EAR AND LABYRINTH DISORDERS Show | ||||
Ear Disorders |
Tinnitus |
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| CARDIOVASCULAR SYSTEM DISORDERS Show | ||||
Repolarisation disorders |
QT prolongation in patients with hypokalaemia |
QT prolongation |
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Unspecified arrhythmias |
Palpitations Tachycardia |
Unspecified arrhythmias |
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Ventricular arrhythmias |
Ventricular tachyarrhythmias |
Torsade de Pointes † Cardiac arrest † † (especially in patients with severe underlying proarrhythmic conditions such as clinically significant bradycardia, acute myocardial ischemia) |
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Unspecific cardiovascular symptoms |
Vasodilatation |
Syncope Hypertension Hypotension |
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| RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS Show | ||||
Unspecific respiratory symptoms |
Dyspnea (including asthmatic conditions) |
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| GASTROINTESTINAL DISORDERS Show | ||||
Gastrointestinal symptoms |
Nausea Vomiting Gastrointestinal and abdominal pains |
Anorexia Constipation Dyspepsia Flatulence Gastroenteritis (excl. erosive gastroenteritis) Increased amylase |
Dysphagia Stomatitis |
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Antibiotic induced diarrheal disorders |
Diarrhoea |
Antibiotic associated colitis (in very rare cases associated with life threatening complications) |
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| HEPATOBILIARY DISORDERS Show | ||||
Mild to moderate hepatic reactions |
Increase in transaminases |
Hepatic impairment (incl. LDH increase) Increased bilirubin Increased gamma-glutamyl-transferase Increase in blood alkaline phosphatase |
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Severe hepatic reactions |
Jaundice Hepatitis (predominantly cholestatic) |
Fulminant hepatitis potentially leading to life threatening liver failure (incl. fatal cases) |
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| SKIN AND SUBCUTANEOUS TISSUE DISORDERS Show | ||||
Bullous skin reactions |
Bullous skin reactions like Stevens-Johnson-Syndrome or Toxic Epidermal Necrolysis ( potentially life threatening) |
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| MUSCULOSKELETAL, CONNECTIVE TISSUE AND BONE DISORDERS Show | ||||
Tendon disorders |
Tendonitis |
Tendon rupture |
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Unspecific joint and muscular disorders |
Arthralgia Myalgia |
Increased muscle tone and cramping |
Arthritis Gait disturbance (caused by muscular, tendon or joint symptoms) Exacerbation of symptoms of myasthenia gravis |
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| RENAL AND URINARY DISORDERS Show | ||||
Renal impairment |
Dehydration (caused by diarrhoea or reduced fluid intake) |
Renal impairment Renal failure (due to dehydration esp. in elderly with pre-existing renal disorders) |
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| GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Show | ||||
General feeling of illness |
Feeling unwell Unspecific pain Sweating |
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Infusion site reactions |
Injection and infusion site reactions |
Infusion site (thrombo-) phlebitis |
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General disorders |
Oedema |
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| Show All | ||||
The following undesirable effects have a higher frequency in the subgroup of IV/PO sequentially treated patients:
- Common: increased gamma-glutamyl-transferase
- Uncommon: Ventricular tachyarrhythmias, Hypotension, Oedema, Antibiotic associated colitis (in very rare cases associated with life threatening complications), Seizures of various clinical manifestations (incl. grand mal convulsions), Hallucinations, Renal impairment and Renal failure (due to dehydration esp. in elderly with pre-existing renal disorders)
*Contraindications may vary from country to country, please ensure you consult your local prescribing information before prescribing Avelox®.
For further information on using Avelox® in the management of bacterial infections, please consult your local country specific prescribing information.
