Last reviewed 2026-04-20 · How we verify

MILNACIPRAN

At a glance

Approved indications

No approved indications tracked.

Boxed warnings

• WARNING: SUICIDALITY AND ANTIDEPRESSANT DRUGS SAVELLA is a selective serotonin and norepinephrine reuptake inhibitor (SNRI), similar to some drugs used for the treatment of depression and other psychiatric disorders. Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of such drugs in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on SAVELLA should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. SAVELLA is not approved for use in the treatment of major depressive disorder. SAVELLA is not approved for use in pediatric patients [see Indications and Usage ( 1 ), Warnings and Precautions ( 5.1 ), Use in Specific Populations ( 8.4 )]. WARNING: SUICIDALITY AND ANTIDEPRESSANT DRUGS See full prescribing information for complete boxed warning. Increased risk of suicidal ideation, thinking, and behavior in children, adolescents, and young adults taking antidepressants for major depressive disorder (MDD) and other psychiatric disorder s ( 5.1 ) . SAVELLA is not approved for use in pediatric patients ( 1 , 8.4 ).

Common side effects

• Nausea
• Constipation
• Palpitations
• Vomiting
• Dry mouth
• Headache
• Dizziness
• Insomnia
• Hot flush
• Hyperhidrosis
• Heart rate increased
• Hypertension

Key clinical trials

• Evaluation of the Initial Prescription of Ketamine and Milnacipran in Depression in Patients With a Progressive Disease (PHASE2, PHASE3)
• Efficacy and Safety Study of Levomilnacipran Hydrochloride Extended-Release Capsules in Major Depressive Disorder (PHASE3)
• Clemastine for Improving White Matter and Boosting Antidepressant Response in Late-life Depression (PHASE2)
• A Study to Compare the Efficacy, Safety, and Tolerability of JNJ-42847922 Versus Quetiapine Extended-Release as Adjunctive Therapy to Antidepressants in Adult Participants With Major Depressive Disorder Who Have Responded Inadequately to Antidepressant Therapy (PHASE2)
• Neural Mechanisms of Monoaminergic Engagement in Late-life Depression Treatment Response (NEMO) (PHASE4)
• Effect of Peanut Ball Use ın Prımarıes on Labor Paın, Duratıon of Labor Anxıety and (NA)
• Effect of Foot Massage Performed to the Mother After Bırth on Breastfeedıng Success, Sleep Qualıty and Newborn Stress (NA)
• The Savella Pregnancy Registry

Primary sources

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