Zofran Side Effects

Generic Name: ondansetron

Please note - some side effects for Zofran may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Zofran - for the Consumer

Zofran

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Zofran:

Constipation; diarrhea; dizziness; drowsiness; headache; irritation, redness, pain, or burning at the site of injection; tiredness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; fever; skin tingling or numbness; trouble urinating; vision changes or loss.

Zofran ODT Orally Disintegrating Tablets

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Zofran ODT Orally Disintegrating Tablets:

Constipation; diarrhea; dizziness; drowsiness; headache; tiredness; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; fever; skin tingling or numbness; trouble urinating; vision change or loss.

Zofran Solution

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Zofran Solution:

Constipation; diarrhea; dizziness; drowsiness; headache; tiredness; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; fever; skin tingling or numbness; trouble urinating; vision change or loss.

Zofran Tablets

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Zofran Tablets:

Constipation; diarrhea; dizziness; drowsiness; headache; tiredness; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; fever; skin tingling or numbness; trouble urinating; vision change or loss.

Zofran Side Effects - for the Professional

Zofran Injection

Chemotherapy-Induced Nausea and Vomiting

The adverse events in Table 12 have been reported in adults receiving ondansetron at a dosage of three 0.15-mg/kg doses or as a single 32-mg dose in clinical trials. These patients were receiving concomitant chemotherapy, primarily cisplatin, and I.V. fluids. Most were receiving a diuretic.

* See Neurological.

The following have been reported during controlled clinical trials:

Rare cases of angina (chest pain), electrocardiographic alterations, hypotension, and tachycardia have been reported. In many cases, the relationship to Zofran Injection was unclear.

Constipation has been reported in 11% of chemotherapy patients receiving multiday ondansetron.

In comparative trials in cisplatin chemotherapy patients with normal baseline values of aspartate transaminase (AST) and alanine transaminase (ALT), these enzymes have been reported to exceed twice the upper limit of normal in approximately 5% of patients. The increases were transient and did not appear to be related to dose or duration of therapy. On repeat exposure, similar transient elevations in transaminase values occurred in some courses, but symptomatic hepatic disease did not occur.

Rash has occurred in approximately 1% of patients receiving ondansetron.

There have been rare reports consistent with, but not diagnostic of, extrapyramidal reactions in patients receiving Zofran Injection, and rare cases of grand mal seizure. The relationship to Zofran was unclear.

Rare cases of hypokalemia have been reported. The relationship to Zofran Injection was unclear.

Postoperative Nausea and Vomiting

The adverse events in Table 13 have been reported in ≥2% of adults receiving ondansetron at a dosage of 4 mg I.V. over 2 to 5 minutes in clinical trials. Rates of these events were not significantly different in the ondansetron and placebo groups. These patients were receiving multiple concomitant perioperative and postoperative medications.

* Sites of pain included abdomen, stomach, joints, rib cage, shoulder.

The adverse events in Table 14were the most commonly reported adverse events in pediatric patients receiving ondansetron (a single 0.1-mg/kg dose for pediatric patients weighing 40 kg or less, or 4 mg for pediatric patients weighing more than40 kg) administered intravenously over at least 30 seconds. Rates of these events were not significantly different in the ondansetron and placebo groups. These patients were receiving multiple concomitant perioperative and postoperative medications.

The adverse events in Table 15 were the most commonly reported adverse events in pediatric patients, 1 month to 24 months of age, receiving a single 0.1-mg/kg I.V. dose of ondansetron. The incidence and type of adverse events were similar in both the ondansetron and placebo groups. These patients were receiving multiple concomitant perioperative and postoperative medications.

Observed During Clinical Practice

In addition to adverse events reported from clinical trials, the following events have been identified during post-approval use of intravenous formulations of Zofran. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. The events have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to Zofran.

Arrhythmias (including ventricular and supraventricular tachycardia, premature ventricular contractions, and atrial fibrillation), bradycardia, electrocardiographic alterations (including second-degree heart block, QT interval prolongation, and ST segment depression), palpitations, and syncope.

Flushing. Rare cases of hypersensitivity reactions, sometimes severe (e.g., anaphylaxis/anaphylactoid reactions, angioedema, bronchospasm, cardiopulmonary arrest, hypotension, laryngeal edema, laryngospasm, shock, shortness of breath, stridor) have also been reported.

Liver enzyme abnormalities have been reported. Liver failure and death have been reported in patients with cancer receiving concurrent medications including potentially hepatotoxic cytotoxic chemotherapy and antibiotics. The etiology of the liver failure is unclear.

Pain, redness, and burning at site of injection.

Hiccups

Oculogyric crisis, appearing alone, as well as with other dystonic reactions.

Urticaria

Transient dizziness during or shortly after I.V. infusion.

Eye Disorders

Transient blurred vision, in some cases associated with abnormalities of accommodation. Cases of transient blindness, predominantly during intravenous administration, have been reported. These cases of transient blindness were reported to resolve within a few minutes up to 48 hours.

Side Effects by Body System

General

In general, headache is the most common adverse effect reported. Transient dizziness during or shortly after the IV infusion has also been reported during postmarketing experience.

Gastrointestinal

Gastrointestinal side effects including constipation (up to 15%) and diarrhea have been reported. Several cases of intestinal obstruction have been reported.

A causal relationship between intestinal obstruction and ondansetron has not been established.

Hepatic

Hepatic side effects have included mild elevations of liver function tests. The clinical significance of these elevations is unknown. Cases of jaundice have also been reported rarely. One case of pancreatitis was reported in a patient using ondansetron long-term. Liver failure and death have been reported in patients with cancer receiving concurrent medications, including potentially hepatotoxic cytotoxic chemotherapy and antibiotics, and intravenous ondansetron during postmarketing experience.

Cardiovascular

Cardiovascular side effects have rarely included angina and acute myocardial ischemia. Arrhythmias (including ventricular and supraventricular tachycardia, premature ventricular contractions, and atrial fibrillation), bradycardia, electrocardiographic alterations (including second-degree heart block, QT interval prolongation, and ST segment depression), palpitations, and syncope have been reported with the use of the intravenous ondansetron during postmarketing experience.

One study has suggested that prolongation of the QTc interval may occur in many patients treated with cisplatin and ondansetron simultaneously. In that study QTc prolongation occurred in 6 of 8 patients who received a combination of ondansetron and cisplatin. Five of the patients had prolongations of the QTc interval which were greater than 5%. However, no episodes of arrhythmia, hypotension, ischemia, congestive heart failure or other cardiovascular events were observed.

Similarly, results of a review of the cardiovascular effects of the drug class 5-hydroxytryptamine 3 receptor antagonists in the literature reported that electrocardiographic (ECG) changes were so small to be considered clinically insignificant. ECG changes were most noticeable between 1 to 2 hours after a dose of ondansetron and returned to baseline within 24 hours. To date, no serious cardiac side effects (including torsades de pointes) triggered by ECG interval changes have been connected with the use of 5-HT 3 receptor antagonists.

Hypersensitivity

Hypersensitivity side effects have rarely included rashes. Twenty-four reports of anaphylactoid-anaphylactic reactions following intravenous administration of ondansetron have been reported in postmarketing experience. One report suggests hypersensitivity reactions with 5-HT 3-antagonists may be a class effect and cross-reactive.

Psychiatric

A brief episode of ondansetron-induced depression has been reported in one woman whose depression was controlled with fluoxetine. A 41-year-old woman became suicidally depressed seven days after receiving ondansetron prior to arthroscopy. The depression was controlled with fluvoxamine, alprazolam, and flunitrazepam.

Psychiatric side effects have rarely included depression.

Dermatologic

Dermatologic side effects have included pruritus (5%) and rash (1%). A suspected fixed drug eruption with the lesions appearing macular and pruritic has also been reported. Rechallenge lead to regression of the lesions. Urticaria has been reported with the use of intravenous ondansetron during postmarketing experience.

Nervous system

Rechallenge with ondansetron lead to a reoccurrence of the opisthotonos in one patient. Patients with a history of drug-induced dystonic reactions may have a similar response after ondansetron therapy.

Nervous system side effects have included dizziness (18%) and extrapyramidal reactions, including twitching tremors, opisthotonos, severe jerking movements, and numbness. In many of these cases, diphenhydramine (25 mg to 50 mg) was effective for treatment or prevention. Oculogyric crisis, appearing alone, as well as with other dystonic reactions have also been reported with the use of intravenous ondansetron during postmarketing experience.

Ocular

Ocular side effects have rarely included blurred vision, in some cases associated with abnormalities of accommodation. Rare cases of transient blindness have also been reported, predominantly during intravenous administration.

Transient blindness (a duration of 2 to 3 minutes) generally resolved within 20 minutes up to 48 hours.

Respiratory

Respiratory side effects have included hiccups with the use of intravenous ondansetron during postmarketing experience.

Local

Local side effects have included pain, redness, and burning at injection site with the use of intravenous ondansetron during postmarketing experience.

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