Sancuso Side Effects

Generic name: granisetron

Note: This document contains side effect information about granisetron. Some of the dosage forms listed on this page may not apply to the brand name Sancuso.

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

For the Consumer

Applies to granisetron: oral solution, oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking granisetron (the active ingredient contained in Sancuso) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

• fast or pounding heartbeats;

• fever, body aches, flu symptoms; or

• easy bruising or bleeding; unusual weakness.

Less serious side effects of granisetron may include:

• headache;

• stomach pain or upset, loss of appetite;

• diarrhea or constipation;

• dizziness; or

• sleep problems (insomnia);

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to granisetron: intravenous solution, oral solution, oral tablet, transdermal film extended release

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 (the active ingredient contained in Sancuso) 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 (the active ingredient contained in Sancuso) 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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