Fesoterodine Fumarate Side Effects

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in labeling: Angioedema [see Warnings and Precautions (5.1) ] Urinary Retention [see Warnings and Precautions (5.2) ] Decreased Gastrointestinal Motility [see Warnings and Precautions (5.3) ] Most frequently reported adverse events with fesoterodine fumarate in adult patients with OAB (≥4%) were: dry mouth (placebo, 7%;

fesoterodine fumarate 4 mg, 19%;

fesoterodine fumarate 8 mg, 35%) and constipation (placebo, 2%;

fesoterodine fumarate 4 mg, 4%;

fesoterodine fumarate 8 mg, 6%).

(6.1) To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

Pediatric use information is approved for Pfizer Inc.’s TOVIAZ ® (fesoterodine fumarate) extended-release tablets.

However, due to Pfizer Inc.’s marketing exclusivity rights, this drug product is not labeled with that information.

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.

Adult Overactive Bladder (OAB) The safety of fesoterodine fumarate was evaluated in Phase 2 and 3 controlled trials in a total of 2,859 patients with overactive bladder, of which 2,288 were treated with fesoterodine fumarate.