Granisetron Side Effects
Brand Names: Sancuso, Kytril
Please note - some side effects for Granisetron may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).
Side Effects of Granisetron - for the Consumer
Granisetron
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 Granisetron:
Seek medical attention right away if any of these SEVERE side effects occur when using Granisetron:Anxiety; constipation; diarrhea; dizziness; drowsiness; headache; nausea; trouble sleeping; vomiting; weakness.
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.
Granisetron Solution
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 Granisetron Solution:
Seek medical attention right away if any of these SEVERE side effects occur when using Granisetron Solution:Agitation; anxiety; constipation; diarrhea; dizziness; drowsiness; headache; indigestion; nausea; stomach pain; taste changes; trouble sleeping; vomiting; weakness.
Severe allergic reactions (rash; hives; 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; unusual muscle movement.
Granisetron Tablets
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 Granisetron Tablets:
Seek medical attention right away if any of these SEVERE side effects occur when using Granisetron Tablets:Agitation; anxiety; constipation; diarrhea; dizziness; drowsiness; headache; indigestion; nausea; stomach pain; taste changes; trouble sleeping; vomiting; weakness.
TopSevere allergic reactions (rash; hives; 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; unusual muscle movement.
Granisetron Side Effects - for the Professional
Granisetron
Chemotherapy-Induced Nausea and Vomiting
Over 3,700 patients have received Granisetron hydrochloride tablets in clinical trials with emetogenic cancer therapies consisting primarily of cyclophosphamide or cisplatin regimens.
In patients receiving Granisetron hydrochloride tablets 1 mg bid for 1, 7 or 14 days, or 2 mg qd for 1 day, adverse experiences reported in more than 5% of the patients with comparator and placebo incidences are listed in Table 4.
| Percent of Patients With Event | ||||
|---|---|---|---|---|
| Granisetron Hydrochloride * Tablets 1 mg bid (n = 978) |
Granisetron Hydrochloride* Tablets 2 mg qd (n = 1450) |
Comparator† (n = 599) |
Placebo (n = 185) |
|
|
||||
| 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 hydrochloride 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 hydrochloride tablets.
Hypersensitivity: Rare cases of hypersensitivity reactions, sometimes severe (e.g., 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 hydrochloride in clinical trials.
Table 5 gives the comparative frequencies of the five commonly reported adverse events (≥ 3%) in patients receiving Granisetron hydrochloride 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 hydrochloride injection administration.
| Percent of Patients with Event | ||
|---|---|---|
| Granisetron Hydrochloride Injection* 40 mcg/kg (n = 1268) |
Comparator† (n = 422) |
|
| 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 hydrochloride tablets, 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 hydrochloride tablets and concurrent radiation were similar to those reported by patients receiving Granisetron hydrochloride tablets prior to chemotherapy. The most frequently reported adverse events were diarrhea, asthenia, and constipation. Headache, however, was less prevalent in this patient population.
TopSide Effects by Body System
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.
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, 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.
TopMore resources:
Granisetron - Includes detailed dosage instructions.
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