Kytril Side Effects
Generic name: granisetron
Generic Name: Granisetron
Please note - some side effects for Kytril 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).
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For the consumer For the professional By body system
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Side Effects of Kytril - for the consumer
Kytril
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 Kytril:
Seek medical attention right away if any of these SEVERE side effects occur when using Kytril:Agitation; anxiety; constipation; diarrhea; dizziness; drowsiness; headache; indigestion; nausea; pain, swelling, or redness at the injection site; 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.
Kytril 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 Kytril Solution:
Seek medical attention right away if any of these SEVERE side effects occur when using Kytril 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.
Kytril 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 Kytril Tablets:
Seek medical attention right away if any of these SEVERE side effects occur when using Kytril 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.
For the professional
Kytril
Chemotherapy-Induced Nausea and Vomiting
Over 3700 patients have received Kytril Tablets in clinical trials with emetogenic cancer therapies consisting primarily of cyclophosphamide or cisplatin regimens.
In patients receiving Kytril 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 | ||||
|---|---|---|---|---|
| Kytril* Tablets 1 mg bid (n=978) |
Kytril* Tablets 2 mg qd (n=1450) |
Comparator† (n=599) |
Placebo (n=185) |
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| 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 Kytril 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 Kytril 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 Kytril in clinical trials.
Table 5 gives the comparative frequencies of the five commonly reported adverse events (≥3%) in patients receiving Kytril Injection, 40 mcg/kg, in single-day chemotherapy trials. These patients received chemotherapy, primarily cisplatin, and intravenous fluids during the 24-hour period following Kytril Injection administration.
| Percent of Patients with Event | ||
|---|---|---|
| Kytril Injection* 40 mcg/kg (n=1268) |
Comparator† (n=422) |
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| 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 Kytril, 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 Kytril Tablets and concurrent radiation were similar to those reported by patients receiving Kytril Tablets prior to chemotherapy. The most frequently reported adverse events were diarrhea, asthenia, and constipation. Headache, however, was less prevalent in this patient population.
TopKytril Injection
Chemotherapy-Induced Nausea and Vomiting
The following have been reported during controlled clinical trials or in the routine management of patients. The percentage figures are based on clinical trial experience only. Table 10 gives the comparative frequencies of the five most commonly reported adverse events (≥3%) in patients receiving Kytril Injection, in single-day chemotherapy trials. These patients received chemotherapy, primarily cisplatin, and intravenous fluids during the 24-hour period following Kytril Injection administration. Events were generally recorded over seven days post-Kytril Injection administration. In the absence of a placebo group, there is uncertainty as to how many of these events should be attributed to Kytril, except for headache, which was clearly more frequent than in comparison groups.
| Percent of Patients With Event | ||
|---|---|---|
| Kytril Injection 40 mcg/kg (n=1268) |
Comparator* (n=422) |
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| Headache | 14% | 6% |
| Asthenia | 5% | 6% |
| Somnolence | 4% | 15% |
| Diarrhea | 4% | 6% |
| Constipation | 3% | 3% |
In over 3,000 patients receiving Kytril Injection (2 to 160 mcg/kg) in single-day and multiple-day clinical trials with emetogenic cancer therapies, adverse events, other than those in Table 10, were observed; attribution of many of these events to Kytril is uncertain.
Hepatic: In comparative trials, mainly with cisplatin regimens, elevations of AST and ALT (>2 times the upper limit of normal) following administration of Kytril Injection occurred in 2.8% and 3.3% of patients, respectively. These frequencies were not significantly different from those seen with comparators (AST: 2.1%; ALT: 2.4%).
Cardiovascular: Hypertension (2%); hypotension, arrhythmias such as sinus bradycardia, atrial fibrillation, varying degrees of A-V block, ventricular ectopy including non-sustained tachycardia, and ECG abnormalities have been observed rarely.
Central Nervous System: Agitation, anxiety, CNS stimulation and insomnia were seen in less than 2% of patients. Extrapyramidal syndrome occurred rarely and only in the presence of other drugs associated with this syndrome.
Hypersensitivity: Rare cases of hypersensitivity reactions, sometimes severe (eg, anaphylaxis, shortness of breath, hypotension, urticaria) have been reported.
Other: Fever (3%), taste disorder (2%), skin rashes (1%). In multiple-day comparative studies, fever occurred more frequently with Kytril Injection (8.6%) than with comparative drugs (3.4%, P<0.014), which usually included dexamethasone.
Postoperative Nausea and Vomiting
The adverse events listed in Table 11 were reported in ≥2% of adults receiving Kytril Injection 1 mg during controlled clinical trials.
| Percent of Patients With Event | ||
|---|---|---|
| Kytril Injection 1 mg (n=267) |
Placebo (n=266) |
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| Pain | 10.1 | 8.3 |
| Constipation | 9.4 | 12.0 |
| Anemia | 9.4 | 10.2 |
| Headache | 8.6 | 7.1 |
| Fever | 7.9 | 4.5 |
| Abdominal Pain | 6.0 | 6.0 |
| Hepatic Enzymes Increased | 5.6 | 4.1 |
| Insomnia | 4.9 | 6.0 |
| Bradycardia | 4.5 | 5.3 |
| Dizziness | 4.1 | 3.4 |
| Leukocytosis | 3.7 | 4.1 |
| Anxiety | 3.4 | 3.8 |
| Hypotension | 3.4 | 3.8 |
| Diarrhea | 3.4 | 1.1 |
| Flatulence | 3.0 | 3.0 |
| Infection | 3.0 | 2.3 |
| Dyspepsia | 3.0 | 1.9 |
| Hypertension | 2.6 | 4.1 |
| Urinary Tract Infection | 2.6 | 3.4 |
| Oliguria | 2.2 | 1.5 |
| Coughing | 2.2 | 1.1 |
In a clinical study conducted in Japan, the types of adverse events differed notably from those reported above in Table 11. The adverse events in the Japanese study that occurred in ≥2% of patients and were more frequent with Kytril 1 mg than with placebo were: fever (56% to 50%), sputum increased (2.7% to 1.7%), and dermatitis (2.7% to 0%).
TopBy body system
Nervous system side effects
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 side effects
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 side effects
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 side effects
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 side effects
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 side effects
Other side effects including asthenia (5% to 18%) and fever (up to 8%) have been reported.
TopMore resources:
Kytril - Includes detailed dosage instructions.
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