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Zofran Side Effects

Generic name: ondansetron

Medically reviewed by Drugs.com. Last updated on Jan 27, 2024.

Note: This document contains side effect information about ondansetron. Some dosage forms listed on this page may not apply to the brand name Zofran.

Applies to ondansetron: film, solution, tablet, tablet disintegrating. Other dosage forms:

Serious side effects of Zofran

Along with its needed effects, ondansetron (the active ingredient contained in Zofran) 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 immediately if any of the following side effects occur while taking ondansetron:

More common

Less common

Rare

Incidence not known

Other side effects of Zofran

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

Rare

Incidence not known

For Healthcare Professionals

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

General

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

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

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]

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

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]

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]

Cardiovascular

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

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]

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

References

1. Product Information. Zofran (ondansetron). GlaxoSmithKline. 2001;PROD.

2. Cerner Multum, Inc. UK Summary of Product Characteristics.

3. Cerner Multum, Inc. Australian Product Information.

4. Product Information. Zuplenz (ondansetron). Strativa Pharmaceuticals, a Division of Par Pharmaceuticals, Inc. 2010.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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