Zofran ODT Side Effects

Generic name: ondansetron

Medically reviewed by Drugs.com. Last updated on May 1, 2024.

Note: This document provides detailed information about Zofran ODT Side Effects associated with ondansetron. Some dosage forms listed on this page may not apply specifically to the brand name Zofran ODT.

Applies to ondansetron: injection solution.

Other dosage forms:

• film, solution, tablet, tablet disintegrating

Common side effects of Zofran ODT

Some side effects of ondansetron may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common side effects

• constipation
• headache

Less common side effects

• burning, tingling, or prickling sensations
• drowsiness
• dryness of the mouth
• feeling cold
• itching
• stomach cramps

Incidence not known

• hiccups

Serious side effects of Zofran ODT

Along with its needed effects, ondansetron (the active ingredient contained in Zofran ODT) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking ondansetron:

Rare side effects

• chest pain, discomfort, or tightness
• pain, redness, or burning at the injection site
• skin rash, hives, redness, or itching
• trouble breathing

Incidence not known

• agitation
• blistering, peeling, or loosening of the skin
• blurred vision
• chills
• cold, clammy skin
• confusion
• coughing
• dark-colored urine
• diarrhea
• decreased or irregular heartbeat
• difficulty with breathing or swallowing
• dizziness or fainting
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying position
• fast, pounding, slow, or irregular heartbeat or pulse
• fast, weak pulse
• fever
• fixed position of the eye
• headache
• heart stops
• hives or welts
• hoarseness
• inability to move the eyes
• increased blinking or spasms of the eyelid
• joint or muscle pain
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• light-colored stools
• lightheadedness
• no breathing
• no pulse or blood pressure
• noisy breathing
• overactive reflexes
• pain or discomfort in the arms, jaw, back, or neck
• poor coordination
• red irritated eyes
• red skin lesions, often with a purple center
• restlessness
• shivering
• slow or irregular breathing
• sore throat
• sores, ulcers, or white spots in the mouth or on the lips
• sticking out of the tongue
• stomach pain or swelling
• sweating
• swelling of the face, throat, or tongue
• talking or acting with excitement you cannot control
• trembling or shaking
• trouble with speaking or swallowing
• twitching
• unconscious
• uncontrolled twisting movements of the neck, trunk, arms, or legs
• unusual facial expressions
• unusual tiredness or weakness
• vomiting
• weakness of the arms and legs
• yellow eyes or skin

For healthcare professionals

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

General adverse events

The most frequently reported side effects are headache, constipation, and diarrhea.^[Ref]

Nervous system

• Very common (10% or more): Headache (up to 27%), drowsiness/sedation (up to 23%)
• Common (1% to 10%): Dizziness, paresthesia
• Uncommon (0.1% to 1%): Seizures, movement disorders/extrapyramidal reactions (oculogyric crisis/dystonic reactions, dyskinesia)
• Rare (0.01% to 0.1%): Grand mal seizures^[Ref]

Dizziness occurred during rapid IV administration.

Headache occurred more often in the oral dissolving tablet formulation when taken with water.^[Ref]

Other

• Very common (10% or more): Wound problem (up to 28%), malaise/fatigue (up to 13%)
• Common (1% to 10%): Shivers, pyrexia/fever, cold sensation
• Frequency not reported: Pain, ear disorder^[Ref]

Wound problems occurred at the surgical site in patients given this drug for the treatment of postoperative nausea and vomiting.^[Ref]

Gastrointestinal

• Very common (10% or more): Diarrhea (up to 16%), constipation (up to 11%)
• Common (1% to 10%): Xerostomia, nausea, vomiting, localized anal/rectal burning sensation
• Uncommon (0.1% to 1%): Throat disorder
• Frequency not reported: Gastric symptoms, abdominal pain, flatulence^[Ref]

Localized anal/rectal burning occurred after insertion of the suppository formulation.^[Ref]

Ocular

• Very common (10% or more): Eye disorder (up to 19%)
• Common (1% to 10%): Visual disturbance/transient visual disturbances (e.g., blurred vision)
• Uncommon (0.1% to 1%): Oculogyric crisis
• Very rare (less than 0.01%): Transient blindness
• Frequency not reported: Swollen periocular area^[Ref]

Oculogyric crisis occurred alone and in combination with other dystonic reactions.

Transient visual disturbances, blurred vision, and transient blindness occurred predominantly during rapid IV administration. Many of the cases of blindness resolved from within a few minutes to approximately 28 hours. Most patients were receiving concomitant chemotherapy with cisplatin.^[Ref]

Cardiovascular

• Common (1% to 10%): Sensation of warmth/flushing, bradycardia, hypotension, arrhythmias
• Uncommon (0.1% to 1%): Chest pain with/without ST segment depression
• Rare (0.01% to 0.1%): Transient ECG changes including QT interval prolongation (Torsade de Pointes), angina/chest pain, vascular occlusive events, tachycardia
• Frequency not reported: Hemorrhage
• Postmarketing reports: Cardiopulmonary arrest, shock^[Ref]

Cardiopulmonary arrest and shock occurred during allergic reactions in patients given the IV formulation.^[Ref]

Respiratory

• Common (1% to 10%): Hypoxia, lower respiratory tract disease, expectoration, cough
• Uncommon (0.1% to 1%): Hiccups
• Rare (0.01% to 0.1%): Bronchospasm/asthma
• Postmarketing reports: Shortness of breath, laryngeal edema, stridor, laryngospasm^[Ref]

Laryngospasm occurred during allergic reactions in patients given the IV formulation.^[Ref]

Psychiatric

• Common (1% to 10%): Anxiety/agitation, disturbance in behavior/conduct, sleep disturbance^[Ref]

Genitourinary

• Common (1% to 10%): Gynecological disorder, urinary retention, urinary tract infection/dysuria^[Ref]

Dermatologic

• Common (1% to 10%): Rash, pruritus
• Very rare (less than 0.01%): Toxic skin eruption, toxic epidermal necrolysis^[Ref]

Hepatic

• Common (1% to 10%): Asymptomatic increases in AST/ALT
• Postmarketing reports: Liver failure and death^[Ref]

Transient, asymptomatic increases in AST/ALT 2 times the upper limit of normal commonly occurred in patients receiving chemotherapy with cisplatin, and did not appear to be related to dose/duration of treatment.

Liver failure and death have been reported in patients with cancer receiving potentially hepatotoxic/cytotoxic chemotherapy and antibiotics; however, the etiology of liver failure is unknown.^[Ref]

Local

• Common (1% to 10%): Injection site reactions^[Ref]

Hypersensitivity

• Rare (0.01% to 0.1%): Immediate hypersensitivity reactions (sometimes severe), anaphylaxis/anaphylactoid reactions
• Postmarketing reports: Angioedema^[Ref]

Metabolic

• Rare (0.01% to 0.1%): Hypokalemia
• Frequency not reported: Poor oral intake^[Ref]

Frequently asked questions

• Can you take ondansetron while pregnant?

Further information

Zofran ODT side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer