pms-Ondansetron Adverse Reactions

Clinical Trial Adverse Drug Reactions: Because clinical trials are conducted under very specific conditions the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug. Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates.
Ondansetron hydrochloride has been administered to over 2,500 patients worldwide in controlled clinical trials and has been well-tolerated.
The most frequent adverse events reported in controlled clinical trials were headache (11%) and constipation (4%). Other adverse events include sensations of flushing or warmth (< 1%).
Cardiovascular: There have been rare reports of tachycardia, angina (chest pain), bradycardia, hypotension, syncope and electrocardiographic alterations.
Central Nervous System: There have been rare reports of seizures. Movement disorders and dyskinesia have been reported in two large clinical trials of ondansetron at a rate of 0.1 to 0.3%.
Dermatological: Rash has occurred in approximately 1% of patients receiving ondansetron.
Eye Disorder: Rare cases of transient visual disturbances (e.g., blurred vision) have been reported during or shortly after IV administration of ondansetron, particularly at rates equal to or greater than 30 mg in 15 minutes.
Hypersensitivity: Rare cases of immediate hypersensitivity reactions sometimes severe, including anaphylaxis, bronchospasm, urticaria and angioedema have been reported.
Local Reactions: Pain, redness and burning at the site of injection have been reported.
Metabolic: There were transient increases of SGOT and SGPT of over twice the upper limit of normal in approximately 5% of patients. These increases did not appear to be related to dose or duration of therapy. There have been reports of liver failure and death in patients with cancer receiving concurrent medications including potentially hepatotoxic cytotoxic chemotherapy and antibiotics. The etiology of the liver failure is unclear. There have been rare reports of hypokalemia.
Other: There have been reports of abdominal pain, weakness and xerostomia.
Post-Market Adverse Drug Reactions: Over 250 million patient treatment days of ondansetron hydrochloride have been supplied since the launch of the product worldwide. The following events have been spontaneously reported during post-approval use of ondansetron hydrochloride, although the link to ondansetron cannot always be clearly established.
The adverse event profiles in children and adolescents were comparable to that seen in adults.
Immune Disorders: Rare cases of hypersensitivity reactions, sometimes severe (e.g., laryngeal edema, stridor, laryngospasm and cardiopulmonary arrest) have also been reported.
Cardiovascular Disorders: There have been rare reports (< 0.01%) of myocardial infarction, myocardial ischemia, angina, chest pain with or without ST segment depression, arrhythmias (including ventricular or supraventricular tachycardia, premature ventricular contractions, and atrial fibrillation), electrocardiographic alterations (including second degree heart block), palpitations and syncope.
Rarely and predominantly with IV ondansetron, transient ECG changes including QTc interval prolongation, Torsade de Pointes, ventricular fibrillation, cardiac arrest, and sudden death have been reported (see Cardiovascular under Precautions).
Eye Disorder: There have been very rare cases of transient blindness following ondansetron treatment, generally within the recommended dosing range and predominantly during IV administration.
The majority of blindness cases reported, resolved within 20 minutes. Although most patients had received chemotherapeutic agents, including cisplatin a few cases of transient blindness occurred following ondansetron administration for the treatment of post-operative nausea or vomiting and in the absence of cisplatin treatment. Some cases of transient blindness were reported as cortical in origin.
Hepatobiliary Disorders: Occasional asymptomatic increases in liver function tests have been reported.
Nervous System Disorders: Transient episodes of dizziness (< 0.1%) have been reported predominantly during or upon completion of IV infusion of ondansetron.
Uncommon reports (< 1%) suggestive of extrapyramidal reactions including oculogyric crisis/dystonic reactions (e.g., oro-facial dyskinesia, opisthotonos, tremor, etc.), movement disorders and dyskinesia have been reported without definitive evidence of persistent clinical sequelae.
Serotonin syndrome and neuroleptic malignant syndrome-like events have been reported with 5-HT₃ receptor antagonist antiemetics, including ondansetron hydrochloride, when given in combination with other serotonergic and/or neuroleptic drugs (see Neurologic under Precautions).
Respiratory, Thoracic and Mediastinal Disorders: There have also been rare reports of hiccups.
Skin and Subcutaneous Tissue Disorders: Very rare reports have been received for bullous skin and mucosal reactions, including fatal cases. These reports include toxic skin eruptions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, and have occurred in patients taking other medications that can be associated with bullous skin and mucosal reactions.