Side Effects > Zofran

Zofran Side Effects

Generic Name: Ondansetron

Please note - some side effects for Zofran may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

For the consumer Zofran Zofran ODT Orally Disintegrating Tablets Zofran Solution Zofran Tablets For the professional Zofran Zofran Injection

Side Effects of Zofran - for the consumer

Zofran

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Zofran:

Constipation; diarrhea; dizziness; drowsiness; headache; irritation, redness, pain, or burning at the site of injection; tiredness.

Seek medical attention right away if any of these SEVERE side effects occur when using Zofran:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; fever; skin tingling or numbness; trouble urinating; vision changes or loss.

Zofran ODT Orally Disintegrating Tablets

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Zofran ODT Orally Disintegrating Tablets:

Constipation; diarrhea; dizziness; drowsiness; headache; tiredness; weakness.

Seek medical attention right away if any of these SEVERE side effects occur when using Zofran ODT Orally Disintegrating Tablets:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; fever; skin tingling or numbness; trouble urinating; vision change or loss.

Zofran Solution

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Zofran Solution:

Constipation; diarrhea; dizziness; drowsiness; headache; tiredness; weakness.

Seek medical attention right away if any of these SEVERE side effects occur when using Zofran Solution:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; fever; skin tingling or numbness; trouble urinating; vision change or loss.

Zofran Tablets

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Zofran Tablets:

Constipation; diarrhea; dizziness; drowsiness; headache; tiredness; weakness.

Seek medical attention right away if any of these SEVERE side effects occur when using Zofran Tablets:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; fever; skin tingling or numbness; trouble urinating; vision change or loss.

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For the professional

Zofran

The following have been reported as adverse events in clinical trials of patients treated with ondansetron, the active ingredient of Zofran. A causal relationship to therapy with Zofran has been unclear in many cases.

Chemotherapy-Induced Nausea and Vomiting

The adverse events in Table 5 have been reported in ≥5% of adult patients receiving a single 24-mg Zofran Tablet in 2 trials. These patients were receiving concurrent highly emetogenic cisplatin-based chemotherapy regimens (cisplatin dose ≥50 mg/m2).

Table 5. Principal Adverse Events in US Trials: Single Day Therapy With 24-mg Zofran Tablets (Highly Emetogenic Chemotherapy)

Event	Ondansetron 24 mg q.d. n = 300	Ondansetron 8 mg b.i.d. n = 124	Ondansetron 32 mg q.d. n = 117
Headache	33 (11%)	16 (13%)	17 (15%)
Diarrhea	13 (4%)	9 (7%)	3 (3%)

The adverse events in Table 6 have been reported in ≥5% of adults receiving either 8 mg of Zofran Tablets 2 or 3 times a day for 3 days or placebo in 4 trials. These patients were receiving concurrent moderately emetogenic chemotherapy, primarily cyclophosphamide-based regimens.

Table 6. Principal Adverse Events in US Trials: 3 Days of Therapy With 8-mg Zofran Tablets (Moderately Emetogenic Chemotherapy)

Event	Ondansetron 8 mg b.i.d. n = 242	Ondansetron 8 mg t.i.d. n = 415	Placebo n = 262
Headache	58 (24%)	113 (27%)	34 (13%)
Malaise/fatigue	32 (13%)	37 (9%)	6 (2%)
Constipation	22 (9%)	26 (6%)	1 (<1%)
Diarrhea	15 (6%)	16 (4%)	10 (4%)
Dizziness	13 (5%)	18 (4%)	12 (5%)

Central Nervous System: There have been rare reports consistent with, but not diagnostic of, extrapyramidal reactions in patients receiving ondansetron.

Hepatic: In 723 patients receiving cyclophosphamide-based chemotherapy in US clinical trials, AST and/or ALT values have been reported to exceed twice the upper limit of normal in approximately 1% to 2% of patients receiving Zofran Tablets. The increases were transient and did not appear to be related to dose or duration of therapy. On repeat exposure, similar transient elevations in transaminase values occurred in some courses, but symptomatic hepatic disease did not occur. The role of cancer chemotherapy in these biochemical changes cannot be clearly determined.

There have been reports of liver failure and death in patients with cancer receiving concurrent medications including potentially hepatotoxic cytotoxic chemotherapy and antibiotics. The etiology of the liver failure is unclear.

Integumentary: Rash has occurred in approximately 1% of patients receiving ondansetron.

Other: Rare cases of anaphylaxis, bronchospasm, tachycardia, angina (chest pain), hypokalemia, electrocardiographic alterations, vascular occlusive events, and grand mal seizures have been reported. Except for bronchospasm and anaphylaxis, the relationship to Zofran was unclear.

Radiation-Induced Nausea and Vomiting

The adverse events reported in patients receiving Zofran Tablets and concurrent radiotherapy were similar to those reported in patients receiving Zofran Tablets and concurrent chemotherapy. The most frequently reported adverse events were headache, constipation, and diarrhea.

Postoperative Nausea and Vomiting

The adverse events in Table 7 have been reported in ≥5% of patients receiving Zofran Tablets at a dosage of 16 mg orally in clinical trials. With the exception of headache, rates of these events were not significantly different in the ondansetron and placebo groups. These patients were receiving multiple concomitant perioperative and postoperative medications.

Table 7. Frequency of Adverse Events From Controlled Studies With Zofran Tablets (Postoperative Nausea and Vomiting)

Adverse Event	Ondansetron 16 mg (n = 550)	Placebo (n = 531)
Wound problem	152 (28%)	162 (31%)
Drowsiness/sedation	112 (20%)	122 (23%)
Headache	49 (9%)	27 (5%)
Hypoxia	49 (9%)	35 (7%)
Pyrexia	45 (8%)	34 (6%)
Dizziness	36 (7%)	34 (6%)
Gynecological disorder	36 (7%)	33 (6%)
Anxiety/agitation	33 (6%)	29 (5%)
Bradycardia	32 (6%)	30 (6%)
Shiver(s)	28 (5%)	30 (6%)
Urinary retention	28 (5%)	18 (3%)
Hypotension	27 (5%)	32 (6%)
Pruritus	27 (5%)	20 (4%)

Observed During Clinical Practice

In addition to adverse events reported from clinical trials, the following events have been identified during post-approval use of oral formulations of Zofran. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. The events have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to Zofran.

Cardiovascular: Rarely and predominantly with intravenous ondansetron, transient ECG changes including QT interval prolongation have been reported.

General: Flushing. Rare cases of hypersensitivity reactions, sometimes severe (e.g., anaphylaxis/anaphylactoid reactions, angioedema, bronchospasm, shortness of breath, hypotension, laryngeal edema, stridor) have also been reported. Laryngospasm, shock, and cardiopulmonary arrest have occurred during allergic reactions in patients receiving injectable ondansetron.

Hepatobiliary: Liver enzyme abnormalities

Lower Respiratory: Hiccups

Neurology: Oculogyric crisis, appearing alone, as well as with other dystonic reactions

Skin: Urticaria

Special Senses: Eye Disorders: Cases of transient blindness, predominantly during intravenous administration, have been reported. These cases of transient blindness were reported to resolve within a few minutes up to 48 hours.

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Zofran Injection

Chemotherapy-Induced Nausea and Vomiting

The adverse events in Table 12 have been reported in adults receiving ondansetron at a dosage of three 0.15-mg/kg doses or as a single 32-mg dose in clinical trials. These patients were receiving concomitant chemotherapy, primarily cisplatin, and I.V. fluids. Most were receiving a diuretic.

Table 12. Principal Adverse Events in Comparative Trials in Adults

	Number of Adult Patients With Event
	Zofran Injection 0.15 mg/kg x 3 n = 419	Zofran Injection 32 mg x 1 n = 220	Metoclopramide n = 156	Placebo n = 34
Diarrhea	16%	8%	44%	18%
Headache	17%	25%	7%	15%
Fever	8%	7%	5%	3%
Akathisia	0%	0%	6%	0%
Acute dystonic reactions*	0%	0%	5%	0%

* See Neurological.

The following have been reported during controlled clinical trials:

Cardiovascular

Rare cases of angina (chest pain), electrocardiographic alterations, hypotension, and tachycardia have been reported. In many cases, the relationship to Zofran Injection was unclear.

Gastrointestinal

Constipation has been reported in 11% of chemotherapy patients receiving multiday ondansetron.

Hepatic

In comparative trials in cisplatin chemotherapy patients with normal baseline values of aspartate transaminase (AST) and alanine transaminase (ALT), these enzymes have been reported to exceed twice the upper limit of normal in approximately 5% of patients. The increases were transient and did not appear to be related to dose or duration of therapy. On repeat exposure, similar transient elevations in transaminase values occurred in some courses, but symptomatic hepatic disease did not occur.

Integumentary

Rash has occurred in approximately 1% of patients receiving ondansetron.

Neurological

There have been rare reports consistent with, but not diagnostic of, extrapyramidal reactions in patients receiving Zofran Injection, and rare cases of grand mal seizure. The relationship to Zofran was unclear.

Other

Rare cases of hypokalemia have been reported. The relationship to Zofran Injection was unclear.

Postoperative Nausea and Vomiting

The adverse events in Table 13 have been reported in ≥2% of adults receiving ondansetron at a dosage of 4 mg I.V. over 2 to 5 minutes in clinical trials. Rates of these events were not significantly different in the ondansetron and placebo groups. These patients were receiving multiple concomitant perioperative and postoperative medications.

Table 13. Adverse Events in ≥2% of Adults Receiving Ondansetron at a Dosage of 4 mg I.V. over 2 to 5 Minutes in Clinical Trials

	Zofran Injection 4 mg I.V. n = 547 patients	Placebo n = 547 patients
Headache	92 (17%)	77 (14%)
Dizziness	67 (12%)	88 (16%)
Musculoskeletal pain	57 (10%)	59 (11%)
Drowsiness/sedation	44 (8%)	37 (7%)
Shivers	38 (7%)	39 (7%)
Malaise/fatigue	25 (5%)	30 (5%)
Injection site reaction	21 (4%)	18 (3%)
Urinary retention	17 (3%)	15 (3%)
Postoperative CO2-related pain*	12 (2%)	16 (3%)
Chest pain (unspecified)	12 (2%)	15 (3%)
Anxiety/agitation	11 (2%)	16 (3%)
Dysuria	11 (2%)	9 (2%)
Hypotension	10 (2%)	12 (2%)
Fever	10 (2%)	6 (1%)
Cold sensation	9 (2%)	8 (1%)
Pruritus	9 (2%)	3 (<1%)
Paresthesia	9 (2%)	2 (<1%)

* Sites of pain included abdomen, stomach, joints, rib cage, shoulder.

Pediatric Use

The adverse events in Table 14were the most commonly reported adverse events in pediatric patients receiving ondansetron (a single 0.1-mg/kg dose for pediatric patients weighing 40 kg or less, or 4 mg for pediatric patients weighing more than40 kg) administered intravenously over at least 30 seconds. Rates of these events were not significantly different in the ondansetron and placebo groups. These patients were receiving multiple concomitant perioperative and postoperative medications.

Table 14. Frequency of Adverse Events From Controlled Studies in Pediatric Patients 2 to 12 Years of Age

Adverse Event	Ondansetron n = 755 Patients	Placebo n = 731 Patients
Wound problem	80 (11%)	86 (12%)
Anxiety/agitation	49 (6%)	47 (6%)
Headache	44 (6%)	43 (6%)
Drowsiness/sedation	41 (5%)	56 (8%)
Pyrexia	32 (4%)	41 (6%)

The adverse events in Table 15 were the most commonly reported adverse events in pediatric patients, 1 month to 24 months of age, receiving a single 0.1-mg/kg I.V. dose of ondansetron. The incidence and type of adverse events were similar in both the ondansetron and placebo groups. These patients were receiving multiple concomitant perioperative and postoperative medications.

Table 15. Frequency of Adverse Events (Greater Than or Equal to 2% in Either Treatment Group) in Pediatric Patients 1 Month to 24 Months of Age

Adverse Event	Ondansetron n = 336 Patients	Placebo n = 334 Patients
Pyrexia	14 (4%)	14 (4%)
Bronchospasm	2 (<1%)	6 (2%)
Post-procedural pain	4 (1%)	6 (2%)
Diarrhea	6 (2%)	3 (<1%)

Observed During Clinical Practice

In addition to adverse events reported from clinical trials, the following events have been identified during post-approval use of intravenous formulations of Zofran. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. The events have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to Zofran.

Cardiovascular

Arrhythmias (including ventricular and supraventricular tachycardia, premature ventricular contractions, and atrial fibrillation), bradycardia, electrocardiographic alterations (including second-degree heart block, QT interval prolongation, and ST segment depression), palpitations, and syncope.

General

Flushing. Rare cases of hypersensitivity reactions, sometimes severe (e.g., anaphylaxis/anaphylactoid reactions, angioedema, bronchospasm, cardiopulmonary arrest, hypotension, laryngeal edema, laryngospasm, shock, shortness of breath, stridor) have also been reported.

Hepatobiliary

Liver enzyme abnormalities have been reported. Liver failure and death have been reported in patients with cancer receiving concurrent medications including potentially hepatotoxic cytotoxic chemotherapy and antibiotics. The etiology of the liver failure is unclear.

Local Reactions

Pain, redness, and burning at site of injection.

Lower Respiratory

Hiccups

Neurological

Oculogyric crisis, appearing alone, as well as with other dystonic reactions.

Skin

Urticaria

Special Senses

Transient dizziness during or shortly after I.V. infusion.

Eye Disorders

Transient blurred vision, in some cases associated with abnormalities of accommodation. Cases of transient blindness, predominantly during intravenous administration, have been reported. These cases of transient blindness were reported to resolve within a few minutes up to 48 hours.

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