Trintellix Side Effects

6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the label.

Hypersensitivity [see Contraindications (4) ] Clinical Worsening and Suicide Risk [see Warnings and Precautions (5.1) ] Serotonin Syndrome [see Warnings and Precautions (5.2) ] Increased Risk of Bleeding [see Warnings and Precautions (5.3) ] Activation of Mania/Hypomania [see Warnings and Precautions (5.4) ] Discontinuation Syndrome [see Warnings and Precautions (5.5) ] Angle Closure Glaucoma [see Warnings and Precautions (5.6) ] Hyponatremia [see Warnings and Precautions (5.7) ] Most common adverse reactions (incidence ≥5% and at least twice the rate of placebo) were: nausea, constipation and vomiting ( 6 ).

To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals America, Inc.

at 1-877-TAKEDA-7 (1-877-825-3327) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1 Clinical Studies 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 clinical practice.

Patient Exposure TRINTELLIX was evaluated for safety in 5,852 patients (18 years to 88 years of age) diagnosed with MDD who participated in pre- and postmarketing clinical studies;

2,616 of those patients were exposed to TRINTELLIX in 6 to 8 week, placebo-controlled studies at doses ranging from 5 mg to 20 mg once daily;

204 patients were exposed to TRINTELLIX in a 24 to 64 week placebo-controlled maintenance study at doses of 5 mg to 10 mg once daily;

and 429 patients were exposed to TRINTELLIX in a 32 week placebo-controlled maintenance study in the U.S.

at doses of 5 mg, 10 mg, and 20 mg, once daily.