Sanctura Side Effects

Please note - some side effects for Sanctura may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Sanctura - for the Consumer

Sanctura

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 Sanctura:

Blurred vision; constipation; dizziness; drowsiness; dry mouth or eyes; headache; upset stomach.

Seek medical attention right away if any of these SEVERE side effects occur when using Sanctura:

Severe allergic reactions (rash; hives; itching; difficulty swallowing or breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); chest pain; dark urine; difficulty urinating; fainting; fast or irregular heartbeat; hallucinations; mental or mood changes; muscle pain or weakness; red, swollen, peeling, or blistered skin; vision changes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Sanctura XR Extended-Release Capsules

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 Sanctura XR Extended-Release Capsules:

Constipation; dry mouth or eyes; gas; nasal dryness; nausea; upset stomach.

Seek medical attention right away if any of these SEVERE side effects occur when using Sanctura XR Extended-Release Capsules:

Severe allergic reactions (rash; hives; itching; difficulty swallowing or breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); chest pain; dark urine; difficulty urinating; fainting; fast or irregular heartbeat; hallucinations; mental or mood changes; muscle pain or weakness; red, swollen, peeling, or blistered skin; vision changes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Top

Sanctura Side Effects - for the Professional

Sanctura

The safety of Sanctura® was evaluated in Phase 2 and 3 controlled clinical trials in a total of 2975 patients, who were treated with Sanctura® (N=1673), placebo (N=1056) or active control medications (N=246). Of this total, 1181 patients participated in two, 12-week, Phase 3, U.S., efficacy and safety studies and a 9-month open-label extension. Of this total, 591 patients received Sanctura® 20 mg twice daily. In all controlled trials combined, 232 and 208 patients received treatment with Sanctura® for at least 24 and 52 weeks, respectively.

In all placebo-controlled trials combined, the incidence of serious adverse events was 2.9% among patients receiving Sanctura® 20 mg twice daily and 1.5% among patients receiving placebo. Of these, 0.2% and 0.3% were judged to be at least possibly related to treatment with Sanctura® or placebo, respectively, by the investigator.

Table 4 lists treatment emergent adverse events from the combined 12-week U.S. safety and efficacy trials that were judged to be at least possibly related to treatment with Sanctura® by the investigator, were reported by at least 1% of patients, and were reported more frequently in the Sanctura® group than in the placebo group.

The two most common adverse events reported by patients receiving Sanctura® 20 mg twice daily were dry mouth and constipation. The single most frequently reported adverse event for Sanctura®, dry mouth, occurred in 20.1% of Sanctura® treated patients and 5.8% of patients receiving placebo. In the two Phase 3 U.S. studies, dry mouth led to discontinuation in 1.9% of patients treated with Sanctura® 20 mg twice daily. For the patients who reported dry mouth, most had their first occurrence of the event within the first month of treatment.

Table 4. Incidence (%) of adverse events judged at least possibly related to treatment with Sanctura®, reported in greater than or equal to 1% of all patients treated with Sanctura® and more frequent with Sanctura® (20 mg twice daily) than placebo in Studies 1 and 2 combined

Adverse Event	Placebo (N=590)	Sanctura® 20 mg twice daily (N=591)
Abbreviations: NOS=not otherwise specified
Gastrointestinal Disorders
Dry mouth	34 ( 5.8)	119 (20.1)
Constipation	27 (4.6)	57 (9.6)
Abdominal pain upper	7 (1.2)	9 (1.5)
Constipation aggravated	5 (0.8)	8 (1.4)
Dyspepsia	2 (0.3)	7 (1.2)
Flatulence	5 (0.8)	7 (1.2)
Nervous System Disorders
Headache	12 (2.0)	25 (4.2)
General Disorders
Fatigue	8 (1.4)	11 (1.9)
Renal and Urinary Disorders
Urinary retention	2 (0.3)	7 (1.2)
Eye Disorders
Dry eyes NOS	2 (0.3)	7 (1.2)

Other adverse events from the Phase 3, U.S., placebo-controlled trials judged possibly related to treatment with Sanctura® by the investigator, occurring in greater than or equal to 0.5% of Sanctura® treated patients, and more common with Sanctura® than placebo are: tachycardia NOS, vision blurred, abdominal distension, vomiting NOS, dysgeusia, dry throat, and dry skin.

During controlled clinical studies, one event of angioneurotic edema was reported.

Postmarketing Surveillance

Additional spontaneous adverse events, regardless of relationship to drug, reported from marketing experience with trospium chloride include: Gastrointestinal – gastritis; Cardiovascular – palpitations, supraventricular tachycardia, chest pain, syncope, “hypertensive crisis”; Immunological – Stevens-Johnson syndrome, anaphylactic reaction, angioedema; Nervous System – vision abnormal, hallucinations and delirium; Musculoskeletal – rhabdomyolysis; General – rash.

Top

Side Effects by Body System - for Healthcare Professionals

Cardiovascular

Cardiovascular side effects including palpitations, supraventricular tachycardia, chest pain, and 'hypertensive crisis' have been reported during postmarketing experience.

Gastrointestinal

Gastrointestinal side effects most commonly reported have included dry mouth (20.1% to 21.8%), constipation (9.5% to 9.6%), and abdominal pain (3.1%). Abdominal distention, dry throat, upper abdominal pain, aggravated constipation, dyspepsia, vomiting, dysgeusia, and flatulence have been reported in less than 2% of patients. Gastritis has been reported during postmarketing experience. At least one case of abdominal cramps has also been reported.

Nervous system

Nervous system side effects have included headache (4.2%). At least one case of dizziness has been reported.

Renal

Renal side effects have included urinary retention.

Ocular

Ocular side effects have included dry eyes and blurred vision. Abnormal vision has been reported during postmarketing experience.

Psychiatric

Psychiatric side effects including hallucinations and delirium have been reported during postmarketing experience.

Other

Other side effects have included fatigue.

Dermatologic

Dermatologic side effects have included dry skin. Rash has been reported during postmarketing experience.

Hypersensitivity

Hypersensitivity side effects including anaphylactic reaction have been reported during postmarketing experience.

Metabolic

Metabolic side effects including rhabdomyolysis have been reported during postmarketing experience.

Immunologic

Immunologic side effects including Stevens-Johnson syndrome have been reported during postmarketing experience.

Top

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This information does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug of drug combination is safe, effective, or appropriate for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of information provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.