Granisol Side Effects

Generic Name: granisetron,granisetron hydrochloride

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

Granisol Side Effects - for the Professional

Granisol

QT prolongation has been reported with granisetron.

Chemotherapy-Induced Nausea and Vomiting

Over 3700 patients have received granisetron HCl tablets in clinical trials with emetogenic cancer therapies consisting primarily of cyclophosphamide or cisplatin regimens.

In patients receiving granisetron HCl tablets 1 mg bid for 1, 7 or 14 days, or 2 mg daily for 1 day, adverse experiences reported in more than 5% of the patients with comparator and placebo incidences are listed in Table 4.

Table 4 Principal Adverse Events in Clinical Trials

	Percent of Patients With Event
	GranisetronHCl1 Tablets 1 mg twice a day (n=978)	GranisetronHCl 1 Tablets 2 mg once a day (n=1450)	Comparator2 (n=599)	Placebo (n=185)
1 Adverse events were recorded for 7 days when granisetron HCl tablets were given on a single day and for up to 28 days when granisetron HCl tablets were administered for 7 or 14 days. 2 Metoclopramide/dexamethasone; phenothiazines/dexamethasone; dexamethasone alone; prochlorperazine.
Headache	21%	20%	13%	12%
Constipation	18%	14%	16%	8%
Asthenia	14%	18%	10%	4%
Diarrhea	8%	9%	10%	4%
Abdominal pain	6%	4%	6%	3%
Dyspepsia	4%	6%	5%	4%

Other adverse events reported in clinical trials were:

Gastrointestinal: In single-day dosing studies in which adverse events were collected for 7 days, nausea (20%) and vomiting (12%) were recorded as adverse events after the 24-hour efficacy assessment period.

Hepatic: In comparative trials, elevation of AST and ALT (>2 times the upper limit of normal) following the administration of granisetron HCl tablets occurred in 5% and 6% of patients, respectively. These frequencies were not significantly different from those seen with comparators (AST: 2%; ALT: 9%).

Cardiovascular: Hypertension (1%); hypotension, angina pectoris, atrial fibrillation, and syncope have been observed rarely.

Central Nervous System: Dizziness (5%), insomnia (5%), anxiety (2%), somnolence (1%). One case compatible with, but not diagnostic of, extrapyramidal symptoms has been reported in a patient treated with granisetron HCl tablets.

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

Other: Fever (5%). Events often associated with chemotherapy also have been reported: leukopenia (9%), decreased appetite (6%), anemia (4%), alopecia (3%), thrombocytopenia (2%).

Over 5000 patients have received injectable granisetron in clinical trials.

Table 5 gives the comparative frequencies of the five commonly reported adverse events (≥3%) in patients receiving granisetron HCl injection, 40 mcg/kg, in single-day chemotherapy trials. These patients received chemotherapy, primarily cisplatin, and intravenous fluids during the 24-hour period following granisetron HCl injection administration.

Table 5 Principal Adverse Events in Clinical Trials - Single-Day Chemotherapy

	Percent of Patients with Event
	Granisetron HCl Injection1 40 mcg/kg (n=1268)	Comparator2 (n=422)
1 Adverse events were generally recorded over 7 days post-granisetron HCl injection administration. 2 Metoclopramide/dexamethasone and phenothiazines/dexamethasone.
Headache	14%	6%
Asthenia	5%	6%
Somnolence	4%	15%
Diarrhea	4%	6%
Constipation	3%	3%

In the absence of a placebo group, there is uncertainty as to how many of these events should be attributed to granisetron, except for headache, which was clearly more frequent than in comparison groups.

Radiation-Induced Nausea and Vomiting

In controlled clinical trials, the adverse events reported by patients receiving granisetron HCl tablets and concurrent radiation were similar to those reported by patients receiving granisetron HCl tablets prior to chemotherapy. The most frequently reported adverse events were diarrhea, asthenia, and constipation. Headache, however, was less prevalent in this patient population.

Postmarketing Experience

QT prolongation has been reported with granisetron.

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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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