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Sancuso Side Effects

Generic Name: granisetron

Note: This document contains side effect information about granisetron. Some of the dosage forms listed on this page may not apply to the brand name Sancuso.

For the Consumer

Applies to granisetron: intravenous solution

Other dosage forms:

Along with its needed effects, granisetron (the active ingredient contained in Sancuso) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking granisetron:

Less Common

  • Blurred vision
  • fever
  • nervousness
  • pounding in the ears
  • slow or fast heartbeat

Rare

  • Arm, back, or jaw pain
  • chest pain or discomfort
  • chest tightness or heaviness
  • confusion
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • fainting
  • irregular heartbeat
  • nausea
  • shortness of breath
  • skin rash, hives, and itching
  • sweating

Some side effects of granisetron may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More Common

  • Abdominal or stomach pain
  • diarrhea
  • difficulty having a bowel movement (stool)
  • headache
  • lack or loss of strength
  • unusual tiredness or weakness
  • vomiting

Less Common

  • Agitation
  • dizziness
  • drowsiness
  • fear
  • heartburn
  • indigestion
  • sleepiness or unusual drowsiness
  • sour stomach
  • trouble with sleeping
  • unusual taste in the mouth

For Healthcare Professionals

Applies to granisetron: intravenous solution, oral solution, oral tablet, subcutaneous suspension extended release, transdermal film extended release

General

ORAL: The most commonly reported side effects included headache, constipation, and asthenia.

PARENTERAL: The most commonly reported side effects included injection site reactions, constipation, headache, and diarrhea.

TRANSDERMAL: The most commonly reported side effects included constipation, QT prolongation, and headache.[Ref]

Local

PARENTERAL:

Very common (10% or more): Any injection site reactions (up to 62%), bruising/hematoma (up to 45%), tenderness (up to 27%), pain (up to 20%), mass/nodule (up to 18%), erythema/redness (up to 17%)

Common (1% to 10%): Bleeding, induration/swelling, infection at injection site, other

Frequency not reported: Discoloration, irritation, lipoma, paresthesia, pruritus, rash, reaction, scab, scar, vesicles, warmth

TRANSDERMAL:

Uncommon (0.1% to 1%): Application site irritation

Frequency not reported: Application site erythema, application site pain, application site pruritus, application site rash, application site reactions

Postmarketing reports: Application site burn, application site discoloration, application site urticaria, application site vesicles, patch non-adhesion[Ref]

Gastrointestinal

ORAL:

Very common (10% or more): Nausea (up to 20%), constipation (up to 18%), vomiting (up to 12%)

Common (1% to 10%): Abdominal pain, diarrhea, dyspepsia

PARENTERAL:

Very common (10% or more): Constipation (up to 22%)

Common (1% to 10%): Abdominal pain, diarrhea, dyspepsia, gastroesophageal reflux

Frequency not reported: Pancreatitis

TRANSDERMAL:

Common (1% to 10%): Constipation

Uncommon (0.1% to 1%): Dry mouth, nausea, retching

Frequency not reported: Abdominal pain, diarrhea, vomiting[Ref]

Nervous system

Drug-induced headache is generally mild. In clinical trials, headache typically resolved spontaneously or was relieved by analgesics.[Ref]

ORAL:

Very common (10% or more): Headache (up to 21%)

Common (1% to 10%): Central nervous system (CNS) stimulation, dizziness, somnolence, taste disorder

Uncommon (0.1% to 1%): Serotonin syndrome

Rare (0.01% to 0.1%): Extrapyramidal syndrome, syncope

Frequency not reported: Autonomic dysfunction, extrapyramidal symptoms, neuromuscular abnormalities

PARENTERAL:

Very common (10% or more): Headache (up to 14%)

Common (1% to 10%): CNS stimulation, dizziness, somnolence, taste disorder

Uncommon (0.1% to 1%): Extrapyramidal reactions, serotonin syndrome

Rare (0.01% to 0.1%): Extrapyramidal syndrome, syncope

TRANSDERMAL:

Uncommon (0.1% to 1%): Headache, vertigo

Rare (0.01% to 0.1%): Dyskinesia, dystonia

Frequency not reported: Dizziness, extrapyramidal reactions, somnolence, syncope[Ref]

Other

ORAL:

Very common (10% or more): Asthenia (up to 18%)

Common (1% to 10%): Fever

PARENTERAL:

Very common (10% or more): Fatigue (up to 21%)

Common (1% to 10%): Asthenia, fever

TRANSDERMAL:

Frequency not reported: Asthenia, fever[Ref]

Hepatic

ORAL:

Common (1% to 10%): ALT elevation, AST elevation, elevated hepatic transaminases, transient ALT increases, transient AST increases

PARENTERAL:

Common (1% to 10%): ALT elevation, AST elevation, transaminases increased, transient ALT increases, transient AST increases

Frequency not reported: Elevation of serum transaminase levels

TRANSDERMAL:

Uncommon (0.1% to 1%): ALT increased, AST increased, GGT increased

Frequency not reported: Elevated hepatic transaminases[Ref]

Psychiatric

ORAL:

Common (1% to 10%): Agitation, anxiety, insomnia

Frequency not reported: Altered mental status

PARENTERAL:

Common (1% to 10%): Agitation, anxiety, insomnia

TRANSDERMAL:

Frequency not reported: Anxiety, insomnia[Ref]

Hematologic

ORAL:

Common (1% to 10%): Anemia, leukopenia, thrombocytopenia

PARENTERAL:

Common (1% to 10%): Anemia, leukopenia, thrombocytopenia

TRANSDERMAL:

Frequency not reported: Anemia, leukopenia, thrombocytopenia[Ref]

Dermatologic

ORAL:

Common (1% to 10%): Alopecia

Uncommon (0.1% to 1%): Rash/skin rashes, urticaria

PARENTERAL:

Common (1% to 10%): Alopecia, rash/skin rashes

Uncommon (0.1% to 1%): Urticaria

TRANSDERMAL:

Frequency not reported: Alopecia, rash, urticaria[Ref]

Cardiovascular

ORAL:

Common (1% to 10%): Hypertension

Uncommon (0.1% to 1%): QT prolongation

Rare (0.01% to 0.1%): Angina pectoris, arrhythmias, atrial fibrillation, ECG abnormalities, hypotension, non-sustained tachycardia, sinus bradycardia, varying degrees of atrioventricular (AV) block, ventricular ectopy

PARENTERAL:

Common (1% to 10%): Hypertension

Uncommon (0.1% to 1%): QT prolongation

Rare (0.01% to 0.1%): Angina pectoris, arrhythmias, atrial fibrillation, ECG abnormalities, hypotension, non-sustained tachycardia, sinus bradycardia, varying degrees of AV block, ventricular ectopy

Frequency not reported: Flushing

Postmarketing reports: Bradycardia, chest pain, palpitations, sick sinus syndrome

TRANSDERMAL:

Common (1% to 10%): QT prolongation

Uncommon (0.1% to 1%): Flushing, generalized edema

Rare (0.01% to 0.1%): Angina pectoris, atrial fibrillation, hypertension, hypotension

Postmarketing reports: Bradycardia, chest pain, palpitations, sick sinus syndrome[Ref]

Metabolic

ORAL:

Common (1% to 10%): Decreased appetite

PARENTERAL:

Common (1% to 10%): Decreased appetite

TRANSDERMAL:

Uncommon (0.1% to 1%): Decreased appetite[Ref]

Hypersensitivity

ORAL:

Uncommon (0.1% to 1%): Anaphylaxis, hypersensitivity reactions

Rare (0.01% to 0.1%): Severe hypersensitivity reactions

PARENTERAL:

Uncommon (0.1% to 1%): Anaphylaxis, hypersensitivity reactions

TRANSDERMAL:

Frequency not reported: Anaphylaxis, hypersensitivity reactions/severe hypersensitivity reactions[Ref]

Respiratory

ORAL:

Uncommon (0.1% to 1%): Shortness of breath

PARENTERAL:

Rare (0.01% to 0.1%): Shortness of breath

TRANSDERMAL:

Rare (0.01% to 0.1%): Shortness of breath[Ref]

Musculoskeletal

TRANSDERMAL:

Uncommon (0.1% to 1%): Arthralgia[Ref]

References

1. "Product Information. Kytril (granisetron)." SmithKline Beecham, Philadelphia, PA.

2. "Product Information. Sancuso (granisetron)." ProStrakan Group, Bedminster, NJ.

3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

4. Cerner Multum, Inc. "Australian Product Information." O 0

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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