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Zofran Injection Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Zofran (ondansetron hydrochloridc) Injection is an antiemetic (anti nausea and vomiting) used to prevent nausea and vomiting that may be caused by surgery or by medicine to treat cancer (chemotherapy). Zofran is available in generic form. Common side effects of Zofran include headache, fever, cold feeling, lightheadedness, dizziness, drowsiness, tiredness, diarrhea, constipation, itching, numbness, tingling, or redness/pain/burning at the injection site.
The recommended adult intravenous dosage of Zofran to prevent nausea and vomiting from chemotherapy is a single 32-mg dose or three 0.15-mg/kg doses. Pediatric and post-operative doses vary. Zofran may interact with phenytoin, phenobarbital, carbamazepine, tramadol, rifabutin, rifampin, amiodarone, mibefradil, cimetidine, clarithromycin, erythromycin, or HIV medicines. Tell your doctor all medications you use. During pregnancy Zofran should be used only when prescribed. It is not known if this drug passes into breast milk. Consult your doctor before breast-feeding.
Our Zofran (ondansetron hydrochloridc) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Zofran Injection in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
- fast, slow, or uneven heartbeats;
- feeling like you might pass out; or
- headache with chest pain and severe dizziness, fainting, fast or pounding heartbeat.
Other common side effects may include:
- diarrhea, constipation;
- itching, numbness, or tingling;
- mild headache; or
- fever, or cold feeling.
Read the entire detailed patient monograph for Zofran Injection (Ondansetron Hydrochloride Injection)
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Zofran Injection Overview - Patient Information: Side Effects
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including: stomach pain, muscle stiffness/spasm, vision changes (e.g., temporary loss of vision, blurred vision, uncontrollable eye movements).
Get medical help right away if any of these rare but very serious side effects occur: chest pain, slow/fast/irregular heartbeat, severe dizziness, fainting.
This medication may increase serotonin and rarely cause a very serious condition called serotonin syndrome/toxicity. The risk increases if you are also taking other drugs that increase serotonin, so tell your doctor or pharmacist of all the drugs you take (see Drug Interactions section). Get medical help right away if you develop some of the following symptoms: fast heartbeat, hallucinations, loss of coordination, severe dizziness, severe nausea/vomiting/diarrhea, twitching muscles, unexplained fever, unusual agitation/restlessness.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Zofran Injection (Ondansetron Hydrochloride Injection)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Zofran Injection FDA Prescribing Information: Side Effects
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
The following adverse reactions have been reported in clinical trials of adult patients treated with ondansetron, the active ingredient of intravenous ZOFRAN across a range of dosages. A causal relationship to therapy with ZOFRAN (ondansetron) was unclear in many cases.
Chemotherapy-Induced Nausea and Vomiting
Table 1: Adverse Reactions Reported in > 5% of
Adult Patients Who Received Ondansetron at a Dosage of Three 0.15-mg/kg Doses
|Adverse Reaction||Number of Adult Patients With Reaction|
|ZOFRAN Injection 0.15 mg/kg x 3
n = 419
n = 156
n = 34
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.
Other: Rare cases of hypokalemia have been reported.
Postoperative Nausea and Vomiting
The adverse reactions in Table 2 have been reported in ≥ 2% of adults receiving ondansetron at a dosage of 4 mg intravenous over 2 to 5 minutes in clinical trials.
Table 2: Adverse Reactions Reported in ≥
2% (and With Greater Frequency than the Placebo Group) of Adult Patients
Receiving Ondansetron at a Dosage of 4 mg Intravenous over 2 to 5 Minutes
|Adverse Reactiona,b||ZOFRAN Injection 4 mg Intravenous
n = 547 patients
n = 547 patients
|Headache||92 (17%)||77 (14%)|
|Drowsiness/sedation||44 (8%)||37 (7%)|
|Injection site reaction||21 (4%)||18 (3%)|
|Fever||10 (2%)||6 (1%)|
|Cold sensation||9 (2%)||8 (1%)|
|Pruritus||9 (2%)||3 ( < 1%)|
|Paresthesia||9 (2%)||2 ( < 1%)|
| aAdverse Reactions: Rates of these reactions were not
significantly different in the ondansetron and placebo groups
bPatients were receiving multiple concomitant perioperative and postoperative medications
Pediatric Use: Rates of adverse reactions were similar in both the ondansetron and placebo groups 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 than 40 kg) administered intravenously over at least 30 seconds. Diarrhea was seen more frequently in patients taking ZOFRAN (2%) compared to placebo ( < 1%) in the 1 month to 24 month age group. These patients were receiving multiple concomitant perioperative and postoperative medications.
The following adverse reactions have been identified during post-approval use of ondansetron. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The reactions have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to ondansetron.
Cardiovascular: Arrhythmias (including ventricular and supraventricular tachycardia, premature ventricular contractions, and atrial fibrillation), bradycardia, electrocardiographic alterations (including second-degree heart block, QT/QTc interval prolongation, and ST segment depression), palpitations, and syncope. Rarely and predominantly with intravenous ondansetron, transient ECG changes including QT/QTc interval prolongation have been reported [see WARNINGS AND PRECAUTIONS].
General: Flushing. Rare cases of hypersensitivity reactions, sometimes severe (e.g., anaphylactic reactions, angioedema, bronchospasm, cardiopulmonary arrest, hypotension, laryngeal edema, laryngospasm, shock, shortness of breath, stridor) have also been reported. A positive lymphocyte transformation test to ondansetron has been reported, which suggests immunologic sensitivity to ondansetron.
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.
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. Transient dizziness during or shortly after intravenous infusion.
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. Transient blurred vision, in some cases associated with abnormalities of accommodation, have also been reported.
Read the entire FDA prescribing information for Zofran Injection (Ondansetron Hydrochloride Injection)
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