REMERON

How does Remeron work? What will it do for me?

Mirtazapine belongs to the group of medications known as tetracyclic antidepressants. Antidepressants are used to help relieve the symptoms of depression such as feeling low, sleeping problems, loss of appetite, and loss of interest in activities that you would normally enjoy doing.

When you have depression, certain chemicals in the brain are out of their normal balance. Antidepressants such as mirtazapine work by helping to bring the chemicals back into balance. Antidepressants usually take at least a few weeks to achieve their beneficial effect, so it is important to have patience and take the medication exactly as prescribed by your doctor.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. As well, some forms of this medication may not be used for all of the conditions discussed here. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

Suicidality and Antidepressant Drugs

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 REMERON® (mirtazapine) Tablets or any other antidepressant 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 antidepressant therapy 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. REMERON (mirtazapine) is not approved for use in pediatric patients.

Get emergency medical help if you have any of these signs of an allergic reaction: skin rash or hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have any of these serious side effects:

• fever, chills, body aches, flu symptoms;
• white patches or sores inside your mouth or on your lips; or
• feeling like you might pass out.

Less serious side effects include:

• drowsiness, dizziness, weakness;
• nausea, stomach pain;
• constipation;
• increased appetite, weight gain;
• dry mouth; or
• thirst.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.