Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The most common adverse reactions (> 4% and > placebo) were dry mouth, and constipation at both 5 mg and 10 mg doses;
and urinary tract infection, and blurred vision at the 10 mg dose ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AvKARE at 1-855-361-3993 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, 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 practice.
Solifenacin has been evaluated for safety in 1811 patients in randomized, placebo-controlled trials.
Expected adverse reactions of antimuscarinic agents are dry mouth, constipation, blurred vision (accommodation abnormalities), urinary retention, and dry eyes.
The incidence of dry mouth and constipation in patients treated with Solifenacin was higher in the 10 mg compared to the 5 mg dose group.
In the four 12-week double-blind clinical trials, severe fecal impaction, colonic obstruction, and intestinal obstruction were reported in one patient each, all in the Solifenacin 10 mg group.
Angioneurotic edema has been reported in one patient taking Solifenacin 5 mg.
Compared to 12 weeks of treatment with Solifenacin, the incidence and severity of adverse reactions were similar in patients who remained on drug for up to 12 months.
The most frequent adverse reaction leading to study discontinuation was dry mouth (1.5%).
5 WARNINGS AND PRECAUTIONS Angioedema and anaphylactic reactions: Reports of angioedema of the face, lips and/or larynx, in some cases occurring after the first dose, have been described.
Anaphylactic reactions have been reported rarely ( 5.1 ) Urinary Retention: Administer with caution to patients with clinically significant bladder outflow obstruction ( 5.2 ) Gastrointestinal Disorders: Use with caution in patients with decreased gastrointestinal motility ( 5.3 ) Central Nervous System Effects: Somnolence has been reported with Solifenacin.
Advise patients not to drive or operate heavy machinery until they know how Solifenacin affects them ( 5.4 ) Controlled Narrow-Angle Glaucoma: Use with caution in patients being treated for narrow-angle glaucoma ( 5.5 ) QT Prolongation: Use with caution in patients with a known history of QT prolongation or patients who are taking medications known to prolong the QT interval ( 5.8 ) 5.1 Angioedema and Anaphylactic Reactions Angioedema of the face, lips, tongue, and/or larynx have been reported with solifenacin.
In some cases angioedema occurred after the first dose.
Cases of angioedema have been reported to occur hours after the first dose or after multiple doses.
Like all medications, Solifenacin Succinate can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: