Eszol Adverse Reactions

Undesirable effects listed as follows have been reported in clinical trials with itraconazole tablets and/or from spontaneous reports from post-marketing experience for all itraconazole formulations.
The table as follows presents adverse drug reactions by System Organ Class. Within each System Organ Class, the adverse drug reactions are presented by incidence, using the following convention: Very common (>1/10); 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), Not known (cannot be estimated from the available data).
Infections and infestations: Uncommon: Sinusitis, Upper respiratory tract infection, Rhinitis.
Blood and lymphatic system disorders: Rare: Leukopenia.
Immune system disorders: Rare: Anaphylactic Reaction, Angioneurotic Oedema and Serum Sickness.
Uncommon: Hypersensitivity*.
Metabolism and nutrition disorders: Not known: Hypertriglyceridemia.
Nervous system disorders: Common: Headache.
Rare: Hypoaesthesia, Paraesthesia, Dysgeusia.
Eye disorders: Rare: Visual Disturbance (Vision Blurred and Diplopia).
Ear and labyrinth disorder: Rare: Transient or permanent Hearing Loss*, Tinnitus.
Cardiac disorders: Rare: Congestive Heart Failure*.
Respiratory, thoracic and mediastinal disorders: Rare: Dyspnoea.
Gastrointestinal disorders: Common: Abdominal Pain, Nausea.
Uncommon: Vomiting, Diarrhoea, Constipation, Dyspepsia, Flatulence.
Rare: Pancreatitis.
Hepatobiliary disorders: Uncommon: Hepatic function abnormal.
Rare: Serious hepatotoxicity (including some cases of fatal acute liver failure)*, Hyperbilirubinaemia.
Skin and subcutaneous tissue disorders: Uncommon: Urticaria, Alopecia, Pruritus.
Rare: Toxic Epidermal Necrolysis, Stevens - Johnson syndrome, Erythema Multiforme, Exfoliative Dermatitis, Leukocytoclastic Vasculitis, Photosensitivity.
Renal and urinary disorders: Rare: Pollakiuria.
Reproductive system and breast disorders: Uncommon: Menstrual disorder.
Rare: Erectile Dysfunction.
General disorders and administration site conditions: Rare: Oedema.
Investigations: Rare: Blood creatine phosphokinase increased.
Description of selected adverse reactions: The following is a list of ADRs associated with itraconazole that have been reported in clinical trials of Itraconazole Oral Solution and Itraconazole I.V., excluding the ADR term 'Injection site inflammation', which is specific to the injection route of administration.
Blood and lymphatic system disorders: Granulocytopenia, Thrombocytopenia.
Immune system disorders: Anaphylactoid reaction.
Metabolism and nutrition disorders: Hyperglycaemia, Hyperkalaemia, Hypokalaemia, Hypomagnesaemia.
Psychiatric disorders: Confusional state.
Nervous system disorders: Peripheral neuropathy*, Dizziness, Somnolence, Tremor.
Cardiac disorders: Cardiac failure, Left ventricular failure, Tachycardia.
Vascular disorders: Hypertension, Hypotension.
Respiratory, thoracic and mediastinal disorders: Pulmonary oedema, Dysphonia, Cough.
Gastrointestinal disorders: Gastrointestinal disorder.
Hepatobiliary disorders: Hepatic failure*, Hepatitis, Jaundice.
Skin and subcutaneous tissue disorders: Rash erythematous, Hyperhidrosis.
Musculoskeletal and connective tissue disorders: Myalgia, Arthralgia.
Renal and urinary disorders: Renal impairment, Urinary incontinence.
General disorders and administration site conditions: Generalised oedema, Face oedema, Chest pain, Pyrexia, Pain, Fatigue, Chills,
Investigations: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood alkaline phosphatase increased, Blood lactate dehydrogenase increased, Blood urea increased, Gamma-glutamyltransferase increased, Hepatic enzyme increased, Urine analysis abnormal.
Paediatric population: The safety of Itraconazole tablets was evaluated in 165 paediatric patients aged 1 to 17 years who participated in 14 clinical trials (4 double-blind, placebo controlled trials; 9 open-label trials; and 1 trial had an open-label phase followed by a double-blind phase). These patients received at least one dose of Itraconazole tablets for the treatment of fungal infections and provided safety data.
Based on pooled safety data from these clinical trials, the commonly reported adverse drug reactions (ADRs) in paediatric patients were Headache (3.0%), Vomiting (3.0%), Abdominal pain (2.4%), Diarrhoea (2.4%), Hepatic function abnormal (1.2%), Hypotension (1.2%), Nausea (1.2%), and Urticaria (1.2%). In general, the nature of ADRs in paediatric patients is similar to that observed in adult subjects, but the incidence is higher in the paediatric patients.
Adverse Drug Reactions: Inform doctors about unexpected reactions after using drugs.