Sancuso Side Effects

Generic Name: granisetron,granisetron hydrochloride

Please note - some side effects for Sancuso may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Sancuso - for the Consumer

Sancuso

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 Sancuso:

Anxiety; constipation; diarrhea; dizziness; drowsiness; headache; nausea; trouble sleeping; vomiting; weakness.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; fainting; fast or irregular heartbeat; fever, chills, or sore throat; severe or persistent skin irritation (eg, redness, rash, bumps, blisters, or itching); stomach pain or swelling; unusual muscle movement.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Sancuso Side Effects - for the Professional

Sancuso

Clinical Trials Experience

The safety of Sancuso was evaluated in a total of 404 patients undergoing chemotherapy who participated in two double-blind, comparator studies with patch treatment durations of up to 7 days. The control groups included a total of 406 patients who received a daily dose of 2 mg oral granisetron, for 1 to 5 days.

Adverse reactions considered by the investigators as drug-related occurred in 8.7% (35/404) of patients receiving Sancuso and 7.1% (29/406) of patients receiving oral granisetron. The most common adverse reaction was constipation that occurred in 5.4% of patients in the Sancuso group and 3.0% of patients in the oral granisetron group.

Table 1 lists the treatment emergent adverse reactions that occurred in at least 3% of patients treated with Sancuso or oral granisetron.

Table 1: Incidence of Adverse Reactions in Double-Blind, Active Comparator Controlled Studies in Cancer Patients Receiving Chemotherapy (Events ≥ 3% in either group)

Body System     Preferred Term	Sancuso TDS N=404 (%)	Oral granisetron N=406 (%)
Gastrointestinal disorders
Constipation	5.4	3.0
Nervous system disorders
Headache	0.7	3.0

5-HT3 receptor antagonists, such as granisetron, may be associated with arrhythmias or ECG abnormalities. Three ECGs were performed on 588 randomized patients in the Phase 3 study: at baseline before treatment, the first day of chemotherapy, and 5 to 7 days after starting chemotherapy. QTcF prolongation greater than 450 milliseconds was seen in a total of 11 (1.9%) patients after receiving granisetron, 8 (2.7%) on oral granisetron and 3 (1.1%) on the patch. No new QTcF prolongation greater than 480 milliseconds was observed in any patient in this study. No arrhythmias were detected in this study.

Granisetron 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 practice.

Adverse events reported in clinical trials with other formulations of granisetron include the following:

Gastrointestinal:  abdominal pain, diarrhea, constipation, elevation of ALT and AST levels, nausea and vomiting

Cardiovascular:  Hypertension, hypotension, angina pectoris, atrial fibrillation and syncope have been observed rarely

Central Nervous System:  dizziness, insomnia, headache, anxiety, somnolence and asthenia

Hypersensitivity:  rare cases of hypersensitivity reactions, sometimes severe (e.g. anaphylaxis, shortness of breath, hypotension, urticaria) have been reported

Other:  fever; events often associated with chemotherapy have also been reported: leucopenia, decreased appetite, anemia, alopecia, thrombocytopenia.

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Side Effects by Body System - for Healthcare Professionals

Nervous system

Nervous system side effects have been reported the most frequently. These have included headache (up to 15% to 52.2%), dizziness (5% to 26.1%), insomnia (5%), anxiety (2%), somnolence (1%), asthenia, agitation, and stimulation. Headache (0.7%) has been reported in patients using the granisetron transdermal system. One case compatible with, but not diagnostic of, extrapyramidal symptoms has been reported.

Granisetron-induced headache is generally mild. In clinical trials, headache typically resolved spontaneously or was relieved by analgesics.

Gastrointestinal

Gastrointestinal side effects have included nausea (20%), constipation (3% to 50%), vomiting (12%), diarrhea (4% to 9%), abdominal pain (4% to 6%), dyspepsia (4% to 6%), flatulence, dry mouth, and taste disturbances. Constipation (5.4%) has been reported in patients using the granisetron transdermal system.

Constipation appears to be dose related. In dose-finding studies, constipation occurred in up to 50% of patients treated with single doses of granisetron 300 mcg/kg. If necessary, constipation may be alleviated by the use of laxatives.

Hepatic

Hepatic side effects have been reported rarely. These have included elevations in serum transaminases (two times normal values). Causality is unknown. Acute pancreatitis has also been reported.

Cardiovascular

Cardiovascular side effects have included hypertension in 1% of patients. Atrial fibrillation, angina pectoris, and syncope have been reported rarely. Hypotension, sinus bradycardia, A-V block, ventricular ectopy, QT prolongation, and ECG changes have been reported as well, although causality is unknown.

Results of a review of the cardiovascular effects of the drug class 5-hydroxytryptamine 3 receptor antagonists in the literature reported that electrocardiographic (ECG) changes were so small to be considered clinically insignificant. ECG changes were most noticeable between 1 to 2 hours after a dose of granisetron and returned to baseline within 24 hours. To date, no serious cardiac side effects (including torsades de pointes) triggered by ECG interval changes have been connected with the use of 5-HT 3 receptor antagonists.

Hypersensitivity

Hypersensitivity side effects have been reported rarely. These have included skin rashes, facial flushing, anaphylactoid reactions, shortness of breath, hypotension, and urticaria. One report suggests hypersensitivity reactions with 5-HT 3-antagonists may be a class effect and cross-reactive.

Other

Other side effects including asthenia (5% to 18%) and fever (up to 8%) have been reported.

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