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Zofran Side Effects

Generic Name: ondansetron

Note: This page contains side effects data for the generic drug ondansetron. It is possible that some of the dosage forms included below may not apply to the brand name Zofran.

For the Consumer

Applies to ondansetron: film, solution, tablet, tablet disintegrating

Other dosage forms:

As well as its needed effects, ondansetron (the active ingredient contained in Zofran) may cause unwanted side effects that require medical attention.

Severity: Major

If any of the following side effects occur while taking ondansetron, check with your doctor immediately:

More common:
  • Confusion
  • dizziness
  • fast heartbeat
  • fever
  • headache
  • shortness of breath
  • weakness
Less common:
  • Decrease in the frequency of urination
  • decrease in the urine volume
  • difficulty with passing urine (dribbling)
  • painful urination
Rare:
  • Arm, back, or jaw pain
  • chest pain or discomfort
  • chest tightness or heaviness
  • convulsions
  • cough
  • decreased urine
  • difficulty with breathing
  • difficulty with swallowing
  • dry mouth
  • fast, pounding, or irregular heartbeat or pulse
  • increased thirst
  • loss of appetite
  • loss of bladder control
  • loss of consciousness
  • mood changes
  • muscle pain or cramps
  • nausea or vomiting
  • noisy breathing
  • numbness or tingling in the hands, feet, or lips
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • skin rash, hives, or itching
  • sweating
  • tightness in the chest
  • total body jerking
  • unusual tiredness or weakness
  • wheezing
Incidence not known:
  • Blurred vision
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • fixed position of the eye
  • heart stops
  • hoarseness
  • inability to move the eyes
  • increased blinking or spasms of the eyelid
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • no breathing
  • no pulse or blood pressure
  • noisy breathing
  • pounding heartbeat
  • slow or irregular breathing
  • sticking out of the tongue
  • sweating
  • trouble with speaking
  • unconscious
  • uncontrolled twisting movements of the neck, trunk, arms, or legs
  • unusual facial expressions

Severity: Minor

Some ondansetron side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common:
  • Anxiety
  • difficulty having a bowel movement (stool)
  • dry mouth
  • general feeling of discomfort or illness
  • hyperventilation
  • irritability
  • restlessness
  • shaking
  • trouble sleeping
Rare:
  • Difficulty with speaking
  • drooling
  • loss of balance control
  • muscle trembling, jerking, or stiffness
  • shuffling walk
  • stiffness of the limbs
  • twisting movements of the body
  • uncontrolled movements, especially of the face, neck, and back
Incidence not known:
  • Feeling of warmth
  • hiccups
  • redness of the face, neck, arms, and occasionally, upper chest
  • redness of the skin
  • welts

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

Dizziness occurred during rapid IV administration.

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

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]

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

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

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]

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

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

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]

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

References

1. "Product Information. Zofran (ondansetron)." Cerenex Pharmaceuticals, Research Triangle Pk, NC.

2. Cerner Multum, Inc. "Australian Product Information." O 0

3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

4. "Product Information. Zuplenz (ondansetron)." Strativa Pharmaceuticals, a Division of Par Pharmaceuticals, Inc., Woodcliff Lake, NJ.

It is possible that some side effects of Zofran may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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