 On September 6, 2016, the FDA wrote a letter to Forest Labs requiring a new warnings to be added to the label related to a link between the drug and acute pancreatitis.After a one-year, open-label study assessing the safety and tolerability of vilazodone in people with major depressive disorder, the most common adverse effects were diarrhea (35.7%), nausea (31.6%), and headache (20.0%); greater than 90% of these adverse effects were mild or moderate.In randomized controlled trials, meanwhile, these rates were 28%, 23.4% and 13.3%, respectively.