Zofran ODT Oral, Oromucosal

Check with your doctor if severe nausea and vomiting continue after leaving the hospital or cancer treatment center.

Do not use this medicine if you are receiving apomorphine (Apokyn®). Using these medicines together may increase risk for more serious problems.

This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

Contact your doctor right away if you have any changes to your heart rhythm. You might feel dizzy or faint, or you might have a fast, pounding, or uneven heartbeat. Make sure your doctor knows if you or anyone in your family has ever had a heart rhythm problem such as QT prolongation.

Check with your doctor right away if you start to have pain or swelling in your stomach area. These may be signs of a serious stomach or bowel problem.

This medicine may make you dizzy. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Along with its needed effects, a medicine 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:

• Confusion
• dizziness
• fast heartbeat
• fever
• headache
• shortness of breath
• weakness

• Decrease in the frequency of urination
• decrease in the urine volume
• difficulty with passing urine (dribbling)
• painful urination

• 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

• 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

Some side effects 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:

• Anxiety
• difficulty having a bowel movement (stool)
• dry mouth
• general feeling of discomfort or illness
• hyperventilation
• irritability
• restlessness
• shaking
• trouble sleeping

• 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

• Feeling of warmth
• hiccups
• redness of the face, neck, arms, and occasionally, upper chest
• redness of the skin
• welts

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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]

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