Recommended Topic Related To:

Kytril

"Dec. 12, 2012 -- Heavy coffee drinkers -- those who drink more than four cups a day -- may cut their risk of dying from cancers of the mouth and throat by nearly half, according to new research.

"We examined coffee drinking habits in "...

Kytril

Kytril

Kytril Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Kytril (granisetron hydrochloride) is used to prevent nausea and vomiting caused by cancer chemotherapy or radiation therapy, and anesthesia used during surgery. It is an antinauseant and antiemetic drug. The brand name Kytril is discontinued in the U.S. This medication may be available in generic form. Common side effects include diarrhea, constipation, stomach pain, weakness, headache, fever, dizziness, drowsiness, trouble sleeping, and anxiety.

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. Other drugs may interact with granisetron. Tell your doctor all prescription and over-the-counter medications and supplements you use. Granisetron should be used only when prescribed during pregnancy. It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

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.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Kytril in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: 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 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. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Kytril (Granisetron) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Kytril Overview - Patient Information: Side Effects

SIDE EFFECTS: Diarrhea, constipation, stomach pain, weakness, headache, fever, dizziness, drowsiness, trouble sleeping, and anxiety may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if this highly unlikely but very serious side effect occurs: unusual muscle movements or stiffness.

Seek immediate medical attention if any of these rare but serious side effects occur: chest pain, fast/irregular heartbeat, severe dizziness, fainting.

A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Kytril (Granisetron)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Kytril FDA Prescribing Information: Side Effects
(Adverse Reactions)

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) »

A A A

Kytril - User Reviews

Kytril User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Kytril sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Cancer

Get the latest treatment options.

Health Resources
Related Supplements
advertisement
advertisement
Use Pill Finder Find it Now See Interactions

Pill Identifier on RxList

  • quick, easy,
    pill identification

Find a Local Pharmacy

  • including 24 hour, pharmacies

Interaction Checker

  • Check potential drug interactions
Search the Medical Dictionary for Health Definitions & Medical Abbreviations