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Zuplenz

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Zuplenz

Zuplenz Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Zuplenz (ondansetron) Oral Soluble Film is an antiemetic used to prevent nausea and vomiting associated with cancer chemotherapy, radiotherapy, and surgery. Common side effects include headache, fatigue, constipation, and diarrhea.

The recommended adult oral dosage of Zuplenz oral soluble film is 24 mg given successively as three 8 mg films administered 30 minutes before the start of single-day chemotherapy, one 8 mg film given three times a day during radiotherapy, or 16 mg given successively as two 8 mg films 1 hour before induction of anesthesia. Zuplenz may interact with apomorphine, or tramadol. Tell your doctor all medications and supplements you use. During pregnancy, Zuplenz should be used only if prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Zuplenz (ondansetron) Oral Soluble Film 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 Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Zuplenz FDA Prescribing Information: Side Effects
(Adverse Reactions)

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 events have been reported in clinical trials of patients treated with ondansetron, the active ingredient of ZUPLENZ. A causal relationship to therapy with ondansetron was unclear in many cases.

Chemotherapy-Induced Nausea and Vomiting

Table 1: Adverse Events Reported in ≥ 5% of Adult Patients After Single Day Therapy Ondansetron HCl Tablets [Highly Emetogenic Chemotherapy (cisplatin dose ≥ 50 mg/m²)]

Adverse Event Ondansetron 24 mg once daily
N=300
Ondansetron 8 mg twice daily
N=124
Ondansetron 32 mg once daily
N=117
Headache 33 (11%) 16 (13%) 17 (15%)
Diarrhea 13 (4%) 9 (7%) 3 (3%)

Table 2: Adverse Events Reported in ≥ 5% of Adult Patients After Three Days of Therapy With Ondansetron HCl Tablets [Moderately Emetogenic Chemotherapy (primarily cyclophosphamide-based regimens)]

Adverse Event Ondansetron 8 mg twice daily
N=242
Ondansetron 8 mg three times daily
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%)

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 ondansetron HCl 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 ondansetron was unclear.

Radiation-Induced Nausea and Vomiting

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

Postoperative Nausea and Vomiting

Table 3: Adverse Events Reported in ≥ 5% of Adult Patients After Single Dose Therapy With Ondansetron HCl Tablets

Adverse Event a,b Ondansetron 16 mg
N=550
Placebo
N=531
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%)
Urinary retention 28 (5%) 18 (3%)
Pruritus 27 (5%) 20 (4%)
aAdverse Events: With the exception of headache, rates of these events were not significantly different in the ondansetron and placebo groups.
bPatients were receiving multiple concomitant perioperative and postoperative medications.

Postmarketing Experience

In addition to adverse events reported from clinical trials, the following events have been identified during post-approval use of oral formulations of ondansetron. Because these events are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The events have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to ondansetron.

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 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

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.

Read the entire FDA prescribing information for Zuplenz (Ondansetron Oral Soluble Film) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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