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What is the most important information I should know about mirtazapine?

You may have thoughts about suicide when you first start taking an antidepressant, especially if you are younger than 24 years old. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

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. Do not use mirtazapine if you have used an MAO inhibitor within the past 14 days. Serious, life-threatening side effects can occur if you take mirtazapine before the MAO inhibitor has cleared from your body.

Before taking mirtazapine, tell your doctor if you have bipolar disorder, liver or kidney disease, seizures, heart disease, a history of heart attack or stroke, or a history of drug abuse or suicidal thoughts.

It may take up to several weeks of using this medicine before your symptoms improve. For best results, keep using the medication as directed. Talk with your doctor if your symptoms do not improve after 4 weeks of treatment. Avoid drinking alcohol. It can increase some of the side effects of mirtazapine. Mirtazapine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

What is mirtazapine?

Mirtazapine is an antidepressant. Mirtazapine affects chemicals in the brain that may become unbalanced and cause depression.

Mirtazapine is used to treat major depressive disorder.

Mirtazapine may also be used for purposes other than those listed in this medication guide.

What should I discuss with my healthcare provider before taking mirtazapine?

You should not take this medication if you are allergic to mirtazapine.

You may have thoughts about suicide while taking an antidepressant, especially if you are younger than 24 years old. Tell your doctor if you have worsening depression or suicidal thoughts during the first several weeks of treatment, or whenever your dose is changed.

Your family or other caregivers should also be alert to changes in your mood or symptoms. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

Do not use mirtazapine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take mirtazapine before the MAO inhibitor has cleared from your body.

Before taking mirtazapine, tell your doctor if you are allergic to any drugs, or if you have:

• liver or kidney disease;

• bipolar disorder (manic depression);

• seizures or epilepsy;

• heart disease, including angina (chest pain);

• a history of heart attack or stroke; or

• a history of drug abuse or suicidal thoughts.

If you have any of these conditions, you may not be able to use mirtazapine, or you may need a dosage adjustment or special tests during treatment.

Mirtazapine is in the FDA pregnancy category C. This means that it is not known whether mirtazapine will harm an unborn baby. Do not take mirtazapine without first talking to your doctor if you are pregnant or could become pregnant during treatment. It is not known whether mirtazapine passes into breast milk. Do not take mirtazapine without first talking to your doctor if you are breast-feeding a baby.

Older adults may be more sensitive to the side effects of this medication.

The orally disintegrating tablet may contain phenylalanine. Talk to your doctor before using this form of mirtazapine if you have phenylketonuria (PKU).