Kytril
- Generic Name: granisetron
- Brand Name: Kytril
Kytril (Granisetron) side effects drug center
What Is Kytril?
Kytril (granisetron hydrochloride) is an antinauseant and antiemetic drug used to prevent nausea and vomiting caused by cancer chemotherapy or radiation therapy, and anesthesia used during surgery. The brand name Kytril is discontinued in the U.S. It may be available in generic form.
What Are Side Effects of Kytril?
Common side effects of Kytril (granisetron hydrochloride) include:
- diarrhea,
- constipation,
- stomach pain or upset,
- loss of appetite,
- weakness,
- headache,
- fever,
- dizziness,
- drowsiness,
- trouble sleeping (insomnia), and
- anxiety.
Tell your doctor if you have highly unlikely but very serious side effects of Kytril (granisetron hydrochloride) including:
- unusual muscle movements or stiffness,
- fast or pounding heartbeats,
- fever,
- body aches,
- flu symptoms,
- easy bruising or bleeding, or
- unusual weakness.
Dosage for Kytril
The recommended adult dosage of oral granisetron hydrochloride is 2 mg once daily or 1 mg twice daily. In the 2 mg once-daily regimen, two 1 mg tablets or 10 mL of granisetron Oral Solution (2 teaspoonfuls, equivalent to 2 mg of granisetron) are given up to 1 hour before chemotherapy.
What Drugs, Substances, or Supplements Interact with Kytril?
Other drugs may interact with granisetron. Tell your doctor all prescription and over-the-counter medications and supplements you use.
Kytril During Pregnancy or Breastfeeding
Granisetron should be used only when prescribed during pregnancy. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.
Additional Information
Our Kytril (granisetron hydrochloride) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
- headache with chest pain and severe dizziness, fainting, fast or pounding heartbeats;
- increased blood pressure--severe headache, buzzing in your ears, anxiety, confusion, shortness of breath; or
- high levels of serotonin in the body--agitation, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting.
Common side effects may include:
- headache, weakness;
- diarrhea, constipation;
- stomach pain, indigestion, loss of appetite;
- sleep problems (insomnia); or
- fever, flu symptoms.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Kytril (Granisetron)
SIDE EFFECTS
QT prolongation has been reported with KYTRIL (see PRECAUTIONS and DRUG INTERACTIONS).
Chemotherapy-Induced Nausea and Vomiting
Over 3700 patients have received KYTRIL (granisetron) Tablets in clinical trials with emetogenic cancer therapies consisting primarily of cyclophosphamide or cisplatin regimens.
In patients receiving KYTRIL (granisetron) 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 Trials1
| Percent of Patients With Event | ||||
| KYTRIL (granisetron) 1 Tablets 1 mg twice a day (n=978) |
KYTRIL (granisetron) 1 Tablets 2 mg once a day (n=1450) |
Comparator2 (n=599) |
Placebo (n=185) |
|
| Headache3 | 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% |
| 1 Adverse events were recorded for 7 days when
KYTRIL (granisetron) Tablets were given on a single day and for up to 28 days when KYTRIL (granisetron)
Tablets were administered for 7 or 14 days. 2 Metoclopramide/dexamethasone; phenothiazines/dexamethasone; dexamethasone alone; prochlorperazine. |
||||
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 24hour efficacy assessment period.
Hepatic: In comparative trials, elevation of AST and ALT ( > 2 times the upper limit of normal) following the administration of KYTRIL (granisetron) 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 (granisetron) 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 (granisetron) in clinical trials.
Table 5 gives the comparative frequencies of the five commonly reported adverse events ( ≥ 3%) in patients receiving KYTRIL (granisetron) 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 (granisetron) Injection administration.
Table 5 : Principal Adverse Events in Clinical Trials — Single-Day
Chemotherapy
| Percent of Patients with Event | ||
| KYTRIL (granisetron) Injection1 40 mcg/kg (n=1268) |
Comparator2 (n=422) |
|
| Headache | 14% | 6% |
| Asthenia | 5% | 6% |
| Somnolence | 4% | 15% |
| Diarrhea | 4% | 6% |
| Constipation | 3% | 3% |
| 1 Adverse events were generally recorded over
7 days post-KYTRIL (granisetron) Injection administration. 2 Metoclopramide/dexamethasone and phenothiazines/dexamethasone |
||
In the absence of a placebo group, there is uncertainty as to how many of these events should be attributed to KYTRIL (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 KYTRIL (granisetron) Tablets and concurrent radiation were similar to those reported by patients receiving KYTRIL (granisetron) 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 KYTRIL (see PRECAUTIONS and DRUG INTERACTIONS).
Read the entire FDA prescribing information for Kytril (Granisetron)
© Kytril Patient Information is supplied by Cerner Multum, Inc. and Kytril Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.