ONMEL SIDE EFFECTS
- Generic Name: itraconazole oral administration
- Brand Name: Onmel
SIDE EFFECTS
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, the adverse reaction rate observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
Patients in the trial for toenail onychomycosis were treated with a dosing regimen of 200 mg once daily for 12 consecutive weeks.
The most commonly reported adverse reaction leading to discontinuation of ONMEL was increased hepatic enzyme (6 subjects, 1.0%), followed by dizziness (3 subjects, 0.5%). No other adverse reaction leading to discontinuation occurred in more than one subject.
The table below lists all adverse reactions reported by at least 1% of patients who received ONMEL during 12 weeks of treatment:
Table 1: Adverse Reactions Occurring at Frequencies ≥ 1% in the Onychomycosis Clinical Trial
| BODY SYSTEM/ADVERSE REACTION | Incidence (%) ONMEL (N = 582) |
Incidence (%) Placebo tablet (N = 191) |
| INFECTIONS AND INFESTATIONS | ||
| Upper respiratory tract infections | 6.0% | 7.3% |
| Bacteriuria | 1.4% | 1.6% |
| Urinary tract infection | 1.0% | 0.5% |
| I NVESTIGATIONS | ||
| Hepatic enzymes increased | 2.9% | 0.0% |
| Electrocardiogram abnormal | 1.4% | 1.6% |
| EAR AND LABYRINTH DISORDERS | ||
| Hypoacusis | 3.3% | 3.1% |
| NERVOUS SYSTEM DISORDERS | ||
| Headache | 2.2% | 1.6% |
| Dizziness | 1.2% | 0.0% |
| GASTROINTESTINAL DISORDERS | ||
| Abdominal pain or discomfort | 1.7% | 2.6% |
| Diarrhea | 1.7% | 3.1% |
| Nausea | 1.7% | 1.6% |
| GENERAL DISORDERS OF ADMINISTRATION SITE CONDITIONS | ||
| Fatigue | 1.5% | 2.6% |
| CARDIAC DISORDERS | ||
| Sinus Bradycardia | 1.0% | 0.0% |
| RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS | ||
| Cough | 1.2% | 0.0% |
| Pharyngolaryngeal pain | 1.0% | 0.5% |
| MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS | ||
| Back pain | 1.2% | 2.1% |
Post Marketing Experience
The following adverse reactions have been identified during post-approval use of itraconazole (all formulations) and are listed in Table 2 below. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establishing a causal relationship to drug exposure.
Table 2: Postmarketing Reports of Adverse Reactions for Itraconazole
| Blood and lymphatic system disorders: | Leukopenia, neutropenia, thrombocytopenia |
| Immune system disorders: | Anaphylaxis; anaphylactic, anaphylactoid and allergic reactions; serum sickness; angioneurotic edema |
| Metabolism and nutritional disorders: | Hypertriglyceridemia, hypokalemia |
| Nervous system disorders: | Peripheral neuropathy, paresthesia, hypoesthesia, headache, dizziness |
| Eye disorders: | Visual disturbances, including vision blurred and diplopia |
| Ear and labyrinth disorders: | Transient or permanent hearing loss, tinnitus |
| Cardiac disorders: | Congestive heart failure |
| Respiratory, thoracic and mediastinal disorders: | Pulmonary edema |
| Gastrointestinal disorders: | Abdominal pain, vomiting, dyspepsia, nausea, diarrhea, constipation, dysgeusia |
| Hepato-biliary disorders: | Serious hepatotoxicity (including some cases of fatal acute liver failure), hepatitis, reversible increases in hepatic enzymes |
| Skin and subcutaneous tissue disorders: | Toxic epidermal necrolysis, Stevens-Johnson syndrome, exfoliative dermatitis, leukocytoclastic vasculitis, erythema multiforme, alopecia, photosensitivity, rash, urticaria, pruritus |
| Musculoskeletal and connective tissue disorders: | Myalgia, arthralgia |
| Renal and urinary disorders: | Urinary incontinence, pollakiuria |
| Reproductive system and breast disorders: | Menstrual disorders, erectile dysfunction |
| General disorders and administration site conditions: | Peripheral edema |
SRC: NLM .