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Note: This document contains side effect information about ondansetron. Some of the dosage forms listed on this page may not apply to the brand name Zuplenz.
Applies to ondansetron: film, solution, tablet, tablet disintegrating
Other dosage forms:
Along with its needed effects, ondansetron (the active ingredient contained in Zuplenz) 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:
Incidence not known
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:
Incidence not known
Applies to ondansetron: injectable solution, intravenous solution, oral disintegrating strip, oral solution, oral tablet, oral tablet disintegrating
The most frequently reported side effects are headache, constipation, and diarrhea.
Dizziness occurred during rapid IV administration.
Headache occurred more often in the oral dissolving tablet formulation when taken with water.
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
Wound problems occurred at the surgical site in patients given this drug for the treatment of postoperative nausea and vomiting.
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
Localized anal/rectal burning occurred after insertion of the suppository formulation.
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
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
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.
Cardiopulmonary arrest and shock occurred during allergic reactions in patients given the IV formulation.
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
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
Laryngospasm occurred during allergic reactions in patients given the IV formulation.
Common (1% to 10%): Anxiety/agitation, disturbance in behavior/conduct, sleep disturbance
Common (1% to 10%): Gynecological disorder, urinary retention, urinary tract infection/dysuria
Common (1% to 10%): Rash, pruritus
Very rare (less than 0.01%): Toxic skin eruption, toxic epidermal necrolysis
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.
Common (1% to 10%): Asymptomatic increases in AST/ALT
Postmarketing reports: Liver failure and death
Common (1% to 10%): Injection site reactions
Rare (0.01% to 0.1%): Immediate hypersensitivity reactions (sometimes severe), anaphylaxis/anaphylactoid reactions
Postmarketing reports: Angioedema
Rare (0.01% to 0.1%): Hypokalemia
Frequency not reported: Poor oral intake
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