Ondansetron Side Effects

Some side effects of ondansetron may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to ondansetron: oral disintegrating strip, oral solution, oral tablet, oral tablet disintegrating

Get emergency medical help if you have any of these signs of an allergic reaction while taking ondansetron: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

• blurred vision or temporary vision loss (lasting from only a few minutes to several hours);

• severe dizziness, feeling short of breath, fainting, fast or pounding heartbeats;

• slow heart rate, trouble breathing;

• anxiety, agitation, shivering;

• feeling like you might pass out; or

• urinating less than usual or not at all.

Less serious side effects of ondansetron may include:

• diarrhea or constipation;

• weakness or tired feeling;

• fever;

• headache; or

• dizziness, drowsiness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to ondansetron: injectable solution, intravenous solution, oral disintegrating strip, oral solution, oral tablet, oral tablet disintegrating

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

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

Gastrointestinal side effects including constipation (up to 15%) and diarrhea have been reported. Several cases of intestinal obstruction have been reported. Nausea and vomiting have been reported with the use of intravenous ondansetron during postmarketing experience.

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

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.

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, syncope, Torsade de points, ventricular fibrillation, and chest discomfort have been reported with the use of intravenous ondansetron during postmarketing experience.

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

Psychiatric side effects have rarely included depression.

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.

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, hyperhidrosis, pruritus, and purpura have been reported with the use of intravenous ondansetron during postmarketing experience.

Nervous system

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. Chills, lethargy, and oculogyric crisis, appearing alone, as well as with other dystonic reactions have also been reported with the use of intravenous ondansetron during postmarketing experience.

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.

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.

Musculoskeletal

Musculoskeletal side effects have included arthralgia reported with the use of intravenous ondansetron during postmarketing experience.

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