SANCTURA SIDE EFFECTS
- Generic Name: trospium chloride tablets
- Brand Name: Sanctura
- Drug Class: Anticholinergics, Genitourinary
SIDE EFFECTS
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
The safety of SANCTURA® was evaluated in 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, 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. Table 1 lists adverse reactions from the combined 12-week U.S. safety and efficacy trials 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 reactions reported by patients receiving SANCTURA® 20 mg twice daily were dry mouth and constipation. The single most frequently reported adverse reaction for SANCTURA®, dry mouth, occurred in 20.1% of SANCTURA® treated patients and 5.8% of patients receiving placebo. In the two 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 1: Incidence (%) of adverse reactions 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 Reaction | Placebo (N=590) |
SANCTURA® 20 mg twice daily (N=591) |
| 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 | 2 (0.3) | 7 (1.2) |
Other adverse reactions from the U.S., placebo-controlled trials , occurring in greater than or equal to 0.5% and less than 1.0% of SANCTURA® treated patients, and more common with SANCTURA® than placebo are: tachycardia , vision blurred, abdominal distension, vomiting, dysgeusia, dry throat, and dry skin.
During controlled clinical studies, one adverse reaction of angioneurotic edema was reported.
Post-marketing Experience
The following adverse reactions have been identified during post-approval use of trospium chloride. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Gastrointestinal – gastritis; Cardiovascular – palpitations, supraventricular tachycardia, chest pain, syncope, “hypertensive crisis”; Immunological – Stevens-Johnson syndrome, anaphylactic reaction, angioedema; Nervous System – dizziness, confusion, vision abnormal, hallucinations, somnolence and delirium; Musculoskeletal – rhabdomyolysis; General – rash.
SRC: NLM .