Class Name(s):

• 28:16.04.92 Antidepressants, Miscellaneous

Pronunciation:

• (mir taz' a peen)

Brand Name(s):

• Remeron^®; also available generically

IMPORTANT WARNING:

Medications such as mirtazapine may increase the risk of suicidal thoughts and actions. This increase was found in children, teenagers, and young adults (less than 24 years of age). The risk may be more likely with the first few months of treatment and when the dose is increased.

Call your doctor right away if you experience any of the following symptoms: new or worsening depression; thinking about harming or killing yourself, or planning or trying to do so; extreme worry; agitation; panic attacks; difficulty falling asleep or staying asleep; aggressive behavior; irritability; acting without thinking; severe restlessness; and frenzied abnormal excitement. Be sure that your family or caregiver knows which symptoms may be serious so they can call the doctor if you are unable to do so.

The doctor or pharmacist will give you the Medication Guide. Read the information carefully and ask your doctor or pharmacist if you have any questions. You also can obtain the Medication Guide from: http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm.

Talk to your doctor about the risks of taking mirtazapine.

WHY is this medicine prescribed?

Mirtazapine is used to treat depression. Mirtazapine is in a class of medications called antidepressants. It works by increasing certain types of activity in the brain to maintain mental balance.

HOW should this medicine be used?

Mirtazapine comes as a tablet and as a disintegrating tablet to take by mouth. Take once a day at bedtime with or without food.

Take mirtazapine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

To take the disintegrating tablet, open the blister pack with dry hands. Place the tablet on your tongue. The tablet will disintegrate on the tongue and can be swallowed with saliva. No water is needed to swallow disintegrating tablets. Once the tablet is removed from the blister pack, use it right away. Do not split mirtazapine disintegrating tablets.

It may take several weeks or longer for you to feel the full benefit of mirtazapine. Continue to take mirtazapine even if you feel well. Do not stop taking mirtazapine without talking to your doctor. Your doctor probably will decrease your dose gradually.

Are there OTHER USES for this medication?

This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

What SPECIAL PRECAUTIONS should I follow?

Before taking mirtazapine,

• tell your doctor or pharmacist if you are allergic to this drug, any part of this drug, or any other drugs, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
• tell your doctor or pharmacist if you are taking the following medications or have stopped taking them within the past two weeks: a monoamine oxidase (MAO) inhibitor such as isocarboxazid, linezolid, methylene blue, phenelzine, selegiline, and tranylcypromine.
• some medications should not be taken with mirtazapine. Other medications may cause dosing changes or extra monitoring when taken with mirtazapine. Make sure you have discussed any medications you are currently taking or plan to take before starting mirtazapine with your doctor and pharmacist. Before starting, stopping, or changing any medications while taking mirtazapine, please get the advice of your doctor or pharmacist.
• the following nonprescription or herbal products may interact with mirtazapine: St. John's wort; trytophan; cimetidine (Tagamet^®). Be sure to let your doctor and pharmacist know that you are taking these medications before you start taking mirtazapine. Do not start any of these medications while taking mirtazapine without discussing with your healthcare provider.
• tell your doctor if you drink or have ever drunk large amounts of alcohol or use or have ever used street drugs or have ever overused prescription medications. Also tell your doctor if you or anyone in your family has or has ever had long QT syndrome (a rare heart problem that may cause irregular heartbeat, fainting, or sudden death). Tell your doctor if you have or have ever had a heart attack, low blood pressure, or high cholesterol or triglycerides, or heart, kidney, or liver disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking mirtazapine, call your doctor.
• you should know that this medication may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you.
• talk to your doctor about the safe use of alcoholic beverages during your treatment with mirtazapine. Alcohol can make the side effects of mirtazapine worse.
• if you have phenylketonuria (PKU, an inherited condition in which a special diet must be followed to prevent damage to your brain that can cause severe intellectual disability), you should know that the orally disintegrating tablets contain aspartame that forms phenylalanine.
• you should know that mirtazapine may cause angle-closure glaucoma (a condition where the fluid is suddenly blocked and unable to flow out of the eye causing a quick, severe increase in eye pressure which may lead to a loss of vision). Talk to your doctor about having an eye examination before you start taking this medication. If you have nausea, eye pain, changes in vision, such as seeing colored rings around lights, and swelling or redness in or around the eye, call your doctor or get emergency medical treatment right away.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Mirtazapine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• drowsiness
• dizziness
• increased weight and appetite

Some side effects can be serious. If you experience any of the following symptoms or those listed in the IMPORTANT WARNING or SPECIAL PRECAUTIONS section, call your doctor immediately or get emergency medical treatment:

• flu-like symptoms, fever, chills, sore throat, mouth sores, or other signs of infection
• fever, sweating, confusion, fast or irregular heartbeat, severe muscle stiffness or twitching, agitation, hallucinations, loss of coordination, nausea, vomiting, or diarrhea
• chest pain, fast heartbeat
• headache; unsteadiness; problems with thinking, concentration, or memory
• unusual bleeding or bruising
• rash; itching; hives or blisters; hoarseness; fever; swollen glands; difficulty breathing or swallowing; swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
• seizures

Mirtazapine may cause other side effects. Call your doctor if you have any unusual problems while you are taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at http://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location - one that is up and away and out of their sight and reach. http://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website http://goo.gl/c4Rm4p for more information.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS^® Patient Medication Information™ Copyright, 2025. The American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: October 15, 2025.