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Granisetron

Medically reviewed by Drugs.com. Last updated on Jul 29, 2020.

Pronunciation

(gra NI se tron)

Index Terms

  • BRL 43694
  • Granisetron HCl
  • Granisetron Hydrochloride
  • Granisol
  • Kytril

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Patch, Transdermal:

Sancuso: 3.1 mg/24 hr (1 ea)

Prefilled Syringe, Subcutaneous:

Sustol: 10 mg/0.4 mL (0.4 mL) [contains polyethylene glycol]

Solution, Intravenous:

Generic: 1 mg/mL (1 mL); 4 mg/4 mL (4 mL)

Solution, Intravenous [preservative free]:

Generic: 0.1 mg/mL (1 mL [DSC]); 1 mg/mL (1 mL)

Tablet, Oral:

Generic: 1 mg

Brand Names: U.S.

  • Sancuso
  • Sustol

Pharmacologic Category

  • Antiemetic
  • Selective 5-HT3 Receptor Antagonist

Pharmacology

Selective 5-HT3-receptor antagonist, blocking serotonin, both peripherally on vagal nerve terminals and centrally in the chemoreceptor trigger zone

Absorption

Oral: Tablets and oral solution are bioequivalent; Transdermal patch: ~66% over 7 days

Distribution

Vd: 2 to 4 L/kg; widely throughout body

Metabolism

Hepatic via CYP1A1 and CYP3A4 N-demethylation, oxidation, and conjugation; some metabolites may have 5-HT3 antagonist activity

Excretion

Urine (11% to 12% as unchanged drug, 48% to 49% as metabolites); feces (34% to 38% as metabolites)

Onset of Action

IV: 1 to 3 minutes

Time to Peak

Transdermal patch: Maximum systemic concentrations: ~48 hours after application (range: 24 to 168 hours); SubQ (extended-release): ~24 hours

Duration of Action

Oral, IV: Generally up to 24 hours; SubQ (extended-release): Remains detectable in the plasma for 7 days

Half-Life Elimination

Oral: 6 hours; IV: Mean range: 5 to 9 hours; SubQ (extended-release): ~24 hours

Protein Binding

~65%

Special Populations: Hepatic Function Impairment

Total clearance is decreased by about 50% in patients with hepatic impairment (due to neoplastic disease) compared to patients with normal hepatic function.

Special Populations: Elderly

Mean values were lower for Cl and longer for half-life.

Special Populations: Gender

Men had a higher Cmax, but there was no difference in AUC.

Use: Labeled Indications

Chemotherapy-associated nausea and vomiting: Prevention of nausea and vomiting associated with initial and repeat courses of emetogenic chemotherapy, including high-dose cisplatin (injection and tablets); prevention of nausea and vomiting associated with anthracycline/cyclophosphamide chemotherapy regimens; prevention of nausea and vomiting associated with moderately and/or highly emetogenic chemotherapy regimens of up to 5 consecutive days of duration (transdermal).

Radiation-associated nausea and vomiting: Prevention of nausea and vomiting associated with radiation therapy, including total body radiation and fractionated abdominal radiation (tablets).

Off Label Uses

Prevention of postoperative nausea and vomiting

Based on the Society for Ambulatory Anesthesia Consensus Guidelines for management of postoperative nausea and vomiting, granisetron may administered prior to the end of surgery to prevent postoperative nausea and vomiting.

Contraindications

Hypersensitivity to granisetron or any component of the formulation or to other 5-HT3 receptor antagonists

Canadian labeling: Additional contraindications (not in US labeling): Concomitant use with apomorphine

Dosing: Adult

Note: Granisol oral solution has been discontinued in the US for more than 1 year.

Prevention of chemotherapy-associated nausea and vomiting:

Oral: 2 mg once daily up to 1 hour before chemotherapy or 1 mg twice daily; the first 1 mg dose should be given up to 1 hour before chemotherapy (with the second 1 mg dose 12 hours later). Administer only on the day(s) chemotherapy is given.

IV: 10 mcg/kg within 30 minutes prior to chemotherapy; only on the day(s) chemotherapy is given.

SubQ (extended-release injection): Moderately emetogenic chemotherapy or anthracycline/cyclophosphamide chemotherapy: 10 mg at least 30 minutes prior to chemotherapy on day 1 (in combination with IV dexamethasone on day 1 and [for anthracycline/cyclophosphamide chemotherapy] oral dexamethasone on days 2 to 4); do not administer more frequently than once every 7 days. May also be administered in combination with an NK1 receptor antagonist antiemetic regimen.

Transdermal patch: Prophylaxis of chemotherapy-related emesis: Apply 1 patch at least 24 hours prior to chemotherapy; may be applied up to 48 hours before chemotherapy. Remove patch a minimum of 24 hours after chemotherapy completion. Maximum duration: Patch may be worn up to 7 days, depending on chemotherapy regimen duration.

Adult guideline recommendations:

American Society of Clinical Oncology (ASCO; Basch 2011): High emetic risk:

IV: 1 mg or 10 mcg/kg on the day(s) chemotherapy is administered (antiemetic regimen also includes dexamethasone and aprepitant or fosaprepitant)

Oral: 2 mg on the day(s) chemotherapy is administered (antiemetic regimen also includes dexamethasone and aprepitant or fosaprepitant)

Multinational Association of Supportive Care in Cancer (MASCC) and European Society of Medical Oncology (ESMO) (Roila 2016):

Highly emetic chemotherapy:

IV: 1 mg or 10 mcg/kg (antiemetic regimen includes dexamethasone and aprepitant/fosaprepitant) prior to chemotherapy on day 1

Oral: 1 mg or 2 mg (antiemetic regimen includes dexamethasone and aprepitant/fosaprepitant) prior to chemotherapy on day 1

Moderately emetic chemotherapy:

IV: 1 mg or 10 mcg/kg (antiemetic regimen includes dexamethasone [and aprepitant/fosaprepitant for AC chemotherapy regimen]) prior to chemotherapy on day 1

Oral: 1 mg or 2 mg (antiemetic regimen includes dexamethasone [and aprepitant/fosaprepitant for AC chemotherapy regimen]) prior to chemotherapy on day 1

Low emetic risk:

IV: 1 mg or 10 mcg/kg prior to chemotherapy on day 1

Oral: 1 mg or 2 mg prior to chemotherapy on day 1

Prophylaxis of radiation therapy-associated emesis: Oral: 2 mg once daily within 1 hour of radiation therapy.

Prevention of postoperative nausea and vomiting (off-label use): IV: 0.35 to 3 mg (5 to 20 mcg/kg) administered at the end of surgery (Gan 2014).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Note: Granisol oral solution has been discontinued in the US for more than 1 year.

Chemotherapy-induced nausea and vomiting (CINV), prevention: Pediatric Oncology Group of Ontario (POGO) guidelines (Dupuis 2013; Patel 2017): Note: POGO guidelines do not recommend a maximum dose as most studies did not cap the dose (Dupuis 2013)

Highly-emetogenic chemotherapy:

Infants <6 months: IV: 40 mcg/kg as a single daily dose prior to chemotherapy; used in combination with dexamethasone

Infants ≥6 months, Children, and Adolescents: IV: 40 mcg/kg as a single daily dose prior to chemotherapy; used in combination with dexamethasone and aprepitant (if no known or suspected drug interactions)

Moderately-emetogenic chemotherapy: Infants, Children, and Adolescents:

IV: 40 mcg/kg as a single daily dose prior to chemotherapy; used in combination with dexamethasone. For patients ≥6 months of age who cannot receive dexamethasone, use granisetron in combination with aprepitant (if no known or suspected drug interactions).

Oral: 40 mcg/kg/dose every 12 hours; used in combination with dexamethasone on chemotherapy days. For patients ≥6 months of age who cannot receive dexamethasone, use granisetron in combination with aprepitant (if no known or suspected drug interactions).

Low-emetogenic chemotherapy: Infants, Children, and Adolescents:

IV: 40 mcg/kg as a single daily dose prior to chemotherapy

Oral: 40 mcg/kg/dose every 12 hours on chemotherapy days

Postoperative nausea and vomiting, prevention: Limited data available: Children and Adolescents: IV: 40 mcg/kg as a single dose; maximum dose: 0.6 mg/dose (Gan 2014); ideal administration time in pediatric patients is not defined; in adults, administration is recommended at the end of surgery; in a granisetron pediatric PONV trial, doses were administered before the surgical incision (Cieslak 1996; Gan 2014). Note: QT prolongation has been observed at this dose in pediatric patients 2 to 16 years of age; monitor closely.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Reconstitution

IV: May be given undiluted or may be further diluted in NS or D5W.

SubQ (extended-release injection): Remove extended-release injection kit from refrigeration at least 60 minutes prior to administration. Allow the syringe and all other contents to warm to room temperature. Activate 1 syringe warming pouch and wrap the syringe in the warming pouch for 5 to 6 minutes to allow to reach body temperature. Do not substitute non-kit components for any components of the administration kit.

Extemporaneously Prepared

0.2 mg/mL Oral Suspension

A 0.2 mg/mL oral suspension may be made with tablets. Crush twelve 1 mg tablets in a mortar and reduce to a fine powder. Add 30 mL distilled water, mix well, and transfer to a bottle. Rinse the mortar with 10 mL cherry syrup and add to bottle. Add sufficient quantity of cherry syrup to make a final volume of 60 mL. Label “shake well”. Stable 14 days at room temperature or refrigerated (Quercia 1997).

Quercia RA, Zhang J, Fan C, et al. Stability of granisetron hydrochloride in an extemporaneously prepared oral liquid. Am J Health Syst Pharm. 1997;54(12):1404-1406.9194985

0.05 mg/mL Oral Suspension

A 0.05 mg/mL oral suspension may be made with tablets and one of three different vehicles (Ora-Sweet, Ora-Plus, or a mixture of methylcellulose 1% and Simple Syrup, N.F.). Crush one 1 mg tablet in a mortar and reduce to a fine powder. Add 20 mL of the chosen vehicle and mix to a uniform paste; transfer to a calibrated bottle. Label "shake well" and "refrigerate". Stable for 91 days refrigerated (Nahata 1998).

Nahata MC, Morosco RS, Hipple TF. Stability of granisetron hydrochloride in two oral suspensions. Am J Health Syst Pharm. 1998;55(23):2511-2513.9853637

Administration

Oral: Doses should be given up to 1 hour prior to initiation of chemotherapy/radiation.

IV: Administer IV push over 30 seconds or as a 5-minute infusion.

SubQ (extended-release injection): For subcutaneous administration only. Administer as a single injection at the back of the upper arm or in abdomen (at least one inch away from the umbilicus). Avoid using areas where the skin is burned, hardened, inflamed, swollen, or otherwise compromised. Inject slowly; may take up to 20 to 30 seconds (product is viscous, pressing the syringe plunger will not result in faster expulsion). A topical anesthetic may be applied at injection site prior to administration. Do not administer if particulate matter or discoloration is observed, if the tip cap is missing or has been tampered with, or the luer fitting is missing or dislodged. Remove from refrigerator at least 60 minutes prior to administration; remove from pack and activate 1 syringe warming pouch and wrap syringe with warming pouch for 5 to 6 minutes to allow warming to body temperature. Injection site reactions may occur; if injection site reaction is not yet resolved prior to the next dose, rotate injection site with next administration.

Transdermal (Sancuso): Apply patch by pressing down firmly to clean, dry, nearly hairless, intact skin on upper outer arm; smooth down with fingers. Wash hands thoroughly after applying. Do not shave hair where applying; clip hair as close to the skin as possible. Do not use on red, irritated, or damaged skin. Do not apply to skin where creams, oils, lotions, powders, or other skin products have been applied; may prevent patch from adhering properly. Remove patch from pouch immediately before application. Do not cut patch. Cover patch application site with clothing to protect from natural or artificial sunlight exposure while patch is applied and for 10 days following removal; granisetron may potentially be affected by natural or artificial sunlight. Do not apply heat (eg, heating pad, heating lamp) over or in area of the transdermal patch; avoid prolonged exposure to heat (may increase plasma concentrations). Do not apply more than 1 patch at a time. Surgical or medical adhesive tape may be applied to lifted edges of patch to keep in place; do not completely cover patch or wrap tape around arm. Contact with water while bathing or showering will not affect patch; however, avoid swimming, saunas, hot tubs, and strenuous exercise. Dispose of any used or unused patches by folding adhesive ends together and discard properly in trash away from children and pets.

Storage

IV: Store at 15°C to 30°C (59°F to 86°F). Protect from light. Do not freeze vials. Stable when mixed in NS or D5W for at least 24 hours at room temperature.

Oral: Store tablet or oral solution at 15°C to 30°C (59°F to 86°F). Protect from light.

SubQ (extended-release injection): Store at 2°C to 8°C (36°F to 46°F); do not freeze. May be placed back in refrigerator after being kept at room temperature; may remain at room temperature for a maximum of 7 days. Protect from light.

Transdermal patch: Store at 20°C to 25°C (68°F to 77°F). Keep patch in original packaging until immediately prior to use.

Drug Interactions

Apomorphine: Antiemetics (5HT3 Antagonists) may enhance the hypotensive effect of Apomorphine. Avoid combination

Haloperidol: QT-prolonging Agents (Indeterminate Risk - Caution) may enhance the QTc-prolonging effect of Haloperidol. Monitor therapy

Panobinostat: Granisetron may enhance the arrhythmogenic effect of Panobinostat. Monitor therapy

QT-prolonging Agents (Highest Risk): QT-prolonging Agents (Indeterminate Risk - Caution) may enhance the QTc-prolonging effect of QT-prolonging Agents (Highest Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Monitor therapy

Serotonergic Agents (High Risk): Antiemetics (5HT3 Antagonists) may enhance the serotonergic effect of Serotonergic Agents (High Risk). This could result in serotonin syndrome. Management: Monitor for signs and symptoms of serotonin syndrome/serotonin toxicity (eg, hyperreflexia, clonus, hyperthermia, diaphoresis, tremor, autonomic instability, mental status changes) when these agents are combined. Exceptions: TraMADol. Monitor therapy

TraMADol: Antiemetics (5HT3 Antagonists) may enhance the serotonergic effect of TraMADol. Management: Monitor for signs and symptoms of serotonin syndrome/serotonin toxicity (eg, hyperreflexia, clonus, hyperthermia, diaphoresis, tremor, autonomic instability, mental status changes) when these agents are combined. Monitor therapy

Adverse Reactions

>10%:

Gastrointestinal: Constipation (oral and IV: 3% to 18%; transdermal: 5%), nausea (20%), vomiting (12%)

Nervous system: Headache (oral and IV: 3% to 21%; transdermal: 1%)

Neuromuscular & skeletal: Asthenia (oral: 14% to 18%; IV: 5%)

1% to 10%:

Cardiovascular: Hypertension (oral and IV: 1% to 2%), prolonged QT interval on ECG (1% to 3%; >450 milliseconds, not associated with any arrhythmias)

Dermatologic: Alopecia (3%), skin rash (IV: 1%)

Gastrointestinal: Abdominal pain (4% to 6%), decreased appetite (6%), diarrhea (oral and IV: 4% to 9%), dysgeusia (IV: 2%), dyspepsia (oral: 6%)

Hematologic & oncologic: Anemia (4%), leukopenia (9%), thrombocytopenia (2%)

Hepatic: Increased serum alanine aminotransferase (>2 x ULN: 3% to 6%), increased serum aspartate aminotransferase (>2 x ULN: 3% to 5%)

Nervous system: Agitation (IV: <2%), anxiety (oral and IV: ≤2%), central nervous system stimulation (IV: <2%), dizziness (5%), drowsiness (1% to 4%), insomnia (oral and IV: ≤5%)

Miscellaneous: Fever (3% to 9%)

<1%, postmarketing, and/or case reports (all routes): Anaphylaxis, angina pectoris, application site reaction (transdermal), atrial fibrillation, atrioventricular block, bradycardia, cardiac arrhythmia, chest pain, ECG abnormality, extrapyramidal reaction, hypersensitivity reaction, hypotension, palpitations, serotonin syndrome, sick sinus syndrome, sinus bradycardia, syncope, ventricular ectopy (includes non-sustained tachycardia)

Warnings/Precautions

Concerns related to adverse effects:

• ECG effects: Selective 5-HT3 antagonists, including granisetron, have been associated with a number of dose-dependent increases in ECG intervals (eg, PR, QRS duration, QT/QTc, JT), usually occurring 1 to 2 hours after IV administration. In general, these changes are not clinically relevant, however, when used in conjunction with other agents that prolong these intervals, arrhythmia may occur. When used with agents that prolong the QT interval (eg, Class I and III antiarrhythmics), clinically relevant QT interval prolongation may occur resulting in torsade de pointes. A number of trials have shown that 5-HT3 antagonists produce QT interval prolongation to variable degrees. Use with caution in patients at risk of QT prolongation and/or ventricular arrhythmia; patients with cardiac disease, electrolyte abnormalities, or who are receiving concomitant cardiotoxic chemotherapy are at higher risk. Reduction in heart rate may also occur with the 5-HT3 antagonists. IV formulations of 5-HT3 antagonists have more association with ECG interval changes, compared to oral formulations.

• GI effects: Constipation may occur with all formulations, although a higher incidence is observed with tablets and the ER subcutaneous injection. Hospitalization due to constipation or fecal impaction has been reported with the ER subcutaneous injection. Progressive ileus and/or gastric distention may be masked by the ER subcutaneous injection and transdermal patch (assess risks/benefits in patients with recent abdominal surgery). Monitor for development of constipation and for decreased bowel activity, particularly in patients at risk for GI obstruction. Granisetron does not stimulate gastric or intestinal peristalsis; do not use it in place of nasogastric suction.

• Hypersensitivity: Hypersensitivity reactions (including anaphylaxis) have been reported with granisetron in patients who have experienced hypersensitivity to other 5-HT3 antagonists (cross-reactivity has been reported). Due to the ER properties of the subcutaneous formulation, granisetron exposure may continue for 5 to 7 days following administration; hypersensitivity reactions may occur up to 7 days or longer following administration and may have an extended course. Monitor for signs/symptoms of hypersensitivity.

• Injection site reactions: Injection site reactions are associated with the subcutaneous ER formulation. Injection site infections have been reported (median onset: 9 days); infections were managed with antibiotics and completely resolved. Bruising and/or hematomas occur in over one-third of patients (median onset: 2 days); may be delayed (~5 days or later following administration). Severe bruising has also been reported. Patients receiving anticoagulant or antiplatelet medications are at higher risk for severe bruising/hematoma at the injection site (consider risk/benefit in these patients). Injection site bleeding has also been observed, occasionally lasting >5 days. Injection site pain/tenderness was commonly reported, usually lasting 5 to 7 days. Pain/tenderness interfered with activity or caused significant discomfort at rest (rare); some patients required pain medications. Injection site nodules occurred in less than one-fifth of patients, usually persisting for 15 to 21 days. Monitor for injection site reactions for at least 2 weeks after administration. If injection site reaction is not yet resolved prior to the next dose, rotate injection site with next administration.

• Serotonin syndrome: Serotonin syndrome (SS) has been reported with 5-HT3 receptor antagonists, predominantly when used in combination with other serotonergic agents (eg, selective serotonin reuptake inhibitors, serotonin and norepinephrine reuptake inhibitors, monoamine oxidase inhibitors, mirtazapine, fentanyl, lithium, tramadol, methylene blue). Some of the cases have been fatal. The majority of SS reports due to 5-HT3 receptor antagonist have occurred in a postanesthesia setting or in an infusion center. SS has also been reported following overdose of another 5-HT3 receptor antagonist. Monitor patients for signs of SS, including mental status changes (eg, agitation, hallucinations, delirium, coma); autonomic instability (eg, tachycardia, labile BP, diaphoresis, dizziness, flushing, hyperthermia); neuromuscular changes (eg, tremor, rigidity, myoclonus, hyperreflexia, incoordination); GI symptoms (eg, nausea, vomiting, diarrhea); and/or seizures. If SS occurs, discontinue 5-HT3 receptor antagonist treatment and begin supportive management.

Disease-related concerns:

• Long QT syndrome: Use with caution in patients with congenital long QT syndrome or other risk factors for QT prolongation (eg, medications known to prolong QT interval, electrolyte abnormalities [hypokalemia or hypomagnesemia], cumulative high-dose anthracycline therapy).

Dosage form specific issues:

• Benzyl alcohol and derivatives: Some dosage forms may contain benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity (“gasping syndrome”) in neonates; the “gasping syndrome” consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension, and cardiovascular collapse (AAP ["Inactive" 1997]; CDC 1982); some data suggest that benzoate displaces bilirubin from protein binding sites (Ahlfors 2001); avoid or use dosage forms containing benzyl alcohol with caution in neonates. See manufacturer’s labeling.

• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson 2002; Lucente 2000; Shelley 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade 1986; CDC 1984). See manufacturer’s labeling.

• Transdermal patch: Do not apply to red, irritated, or damaged skin. Application-site reactions have occurred with use; local reactions were generally mild and did not require discontinuation. If skin reaction is severe or generalized (allergic rash including erythematous, macular, or papular rash or pruritus), remove patch. Cover patch application site with clothing to protect from natural or artificial sunlight exposure while patch is applied and for 10 days following removal; granisetron may potentially be affected by natural or artificial sunlight. Do not apply heat (eg, heating pad, heat lamp) over or in area of the transdermal patch; avoid prolonged exposure to heat (may increase plasma concentrations).

Other warnings/precautions:

• Chemotherapy-associated emesis: Antiemetics are most effective when used prophylactically (Roila 2016). If emesis occurs despite optimal antiemetic prophylaxis, reevaluate emetic risk, disease, concurrent morbidities and medications to assure antiemetic regimen is optimized (Basch 2011).

Monitoring Parameters

Monitor for constipation and for decreased bowel activity. Monitor for signs/symptoms of hypersensitivity. Monitor patients for signs of serotonin syndrome.

Extended-release subcutaneous injection: Monitor for injection site reactions for at least 2 weeks after administration.

Pregnancy Risk Factor

B

Pregnancy Considerations

Adverse events have not been observed in animal reproduction studies. In an ex vivo placental perfusion study, granisetron was shown to cross the placenta in a concentration (dose) dependent manner (Julius 2014). Initial studies note the pharmacokinetics of the transdermal system may be different in pregnant women. A relationship between granisetron plasma concentrations and relief of symptoms of nausea and vomiting of pregnancy was also observed (Caritis 2016). Some dosage forms (injection) may contain benzyl alcohol.

Patient Education

What is this drug used for?

• It is used to prevent upset stomach and throwing up.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Feeling dizzy, sleepy, tired, or weak

• Diarrhea

• Trouble sleeping

• Heartburn

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Severe headache

• Severe dizziness

• Passing out

• Vision changes

• Shortness of breath

• Chest pain

• Fast heartbeat

• Abnormal heartbeat

• Chills

• Sore throat

• Abdominal swelling

• Stomach pain

• Bruising

• Bleeding

• Severe loss of strength and energy

• Injection site pain, tenderness, area that feels hard or bruised, infection, or bleeding lasting longer than 24 hours

• Severe constipation

• Serotonin syndrome like dizziness, severe headache, agitation, sensing things that seem real but are not, fast heartbeat, abnormal heartbeat, flushing, tremors, sweating a lot, change in balance, severe upset stomach, or severe diarrhea

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Further information

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