Mirtazapine is an antidepressant that is used to treat major depressive disorder in adults.

Mirtazapine may also be used for purposes not listed in this medication guide.

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

Do not use mirtazapine if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, tranylcypromine, and others.

Tell your doctor if you also take stimulant medicine, opioid medicine, herbal products, or medicine for depression, mental illness, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting. An interaction with mirtazapine could cause a serious condition called serotonin syndrome.

Tell your doctor if you have ever had:

• low white blood cell counts;
• glaucoma;
• liver or kidney disease;
• low sodium levels in your blood;
• a seizure;
• depression, suicidal thoughts or actions;
• bipolar disorder (manic depression) in you or a family member;
• heart problems or stroke;
• high cholesterol or triglycerides;
• long QT syndrome (in you or a family member); or
• low blood pressure.

Some young people have thoughts about suicide when first taking an antidepressant. Your doctor should check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Tell your doctor if you are pregnant or breastfeeding.

The orally disintegrating tablet may contain phenylalanine and could be harmful if you have phenylketonuria (PKU).

Not approved for use by anyone younger than 18 years old.

Use Remeron Soltab (Oral) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Get emergency medical help if you have signs of an allergic reaction (hives, joint pain, fever, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Report any new or worsening symptoms to your doctor, 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:

• racing thoughts, decreased need for sleep, unusual risk-taking behavior, feelings of extreme happiness or sadness, being more talkative than usual;
• blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• a light-headed feeling, like you might pass out;
• severe rash, blisters, or swelling on the palms of your hands or the soles of your feet;
• a seizure;
• low white blood cell counts--fever, chills, sore throat, cough, sores in your mouth or nose, flu-like symptoms, trouble breathing; or
• low sodium level --headache, confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Common side effects include:

• drowsiness, dizziness;
• increased appetite; or
• weight gain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Drinking alcohol with this medicine can cause side effects.

Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired.