Major depressive disorder is a mental health condition where a patient has extreme and persistently low, sad or gloomy moods. Mirtazapine effectively elevates a patient's mood by affecting certain chemicals in the brain.
There are potentially serious risks in taking this antidepressant. While providing a mental balance, the medicine may change the moods and mental health of patients in ways that are not expected.
Some patients, especially children, teenagers, and young adults, are at a higher risk for increased suicidal thoughts. Adults over 24 may also experience an increase in suicidal thoughts, particularly when their dose is decreased or increased.
The medicine is not usually used to treat children under the age of 18 but has been used in cases where it was the best treatment for the child's mental health.
Patients with mental illnesses such as bipolar disorder or manic depression are also more likely to have increased thoughts and behaviors relating to suicide.
The medicine may cause a serious condition known as serotonin syndrome in some patients. It also increases the risk of developing an infection.
Mirtazapine is the generic name for this antidepressant which is sold in the US as the brand names Remeron Soltab and Remeron. Patients are treated with it only if their doctor prescribed it.
Mirtazapine is known to cause some serious side effects and some of them may be life-threatening. Serious adverse effects include suicidal thoughts, serotonin syndrome, episodes of manic depression (bipolar disorder), weakened immune system, and eye problems.
One of the most serious and life-threatening adverse reactions to this drug are thoughts and acts of suicide.
Call your doctor immediately or seek emergency medical care right away if any of the following thoughts or suicide-related actions occur. There may be other suicidal actions or thoughts not listed here.
Thoughts and actions related to suicide:
Using this antidepressant may also cause a life-threatening condition known as serotonin syndrome. The following are some symptoms of this condition:
Mirtazapine may trigger episodes of manic depression in patients with bipolar disorder (manic-depressive disorder). Some symptoms are as follows. Call your doctor right away if you experience them.
Actions related to manic episodes:
This medicine may decrease white blood cells which may lead to a weakening of your immune system. When this happens, it may be a lot easier for you to get an infection. Tell your doctor right away if you have the following symptoms of an infection:
Some patients develop problems with their eyes while using Mirtazapine. If this happens to you, call your doctor immediately. Symptoms include:
Also call your doctor right away if you notice any of the following general side effects, even though some of them rarely occur:
The following are side effects that may occur, but they may not require medical attention. They can be managed at home and tend to disappear on their own during treatment.
However, if you experience any of them and it becomes worse or bothersome tell your doctor or healthcare professional.
Some patients may experience other side effects not listed in this guide. Tell your doctor or healthcare professional if you experience any unusual symptom while using Mirtazapine.
Your doctor or healthcare professional may also give you advice on ways to reduce or prevent side effects.
You may report side effects by calling the US FDA at 1-800-FDA-1088.
Mirtazapine comes as an immediate-release tablet you take by mouth. It also comes as a tablet that disintegrates/dissolves in your mouth.
Dosage of Mirtazapine varies from patient to patient. Your doctor will decide your dose based on your condition, medical history, and presence of other medical problems if any.
Follow all directions given to you by your doctor, pharmacist and prescription label when taking this medicine. Read the patient information leaflet for additional instructions.
The prescription label should tell you how strong your dose is, the time between each dose, how often you should take it, and the duration of your treatment.
Preparing the oral disintegrating tablet for use:
The following is a general recommended dosage guide. You should stick to the dose prescribed for you by your doctor.
Treatment of depression using the oral disintegrating tablet:
Adults: Begin your treatment by taking 15 milligrams (mg) once a day, preferably at night and at bedtime. If needed, your doctor will adjust your dose but may not prescribe a dose of more than 45 mg per day.
Children: Treatment with Mirtazapine must be determined by your doctor.
It usually takes about 20 to 40 hours for the antidepressant to start working in the body. It may also take about 1 to 2 weeks for your body to adjust to the drug.
If you missed a dose of your medicine, take it as soon as possible. If it is close to the time of your next scheduled dose, skip the missed dose and take the upcoming dose on time. Continue taking your doses according to the schedule.
You may need urgent medical attention if you overdose on Mirtazapine. Call your doctor or 911 right away if this happens. You may also speak with the poison control center by calling 1-800-222-1222.
Your doctor may take precautions when treating you or give you special instructions regarding the use of food, alcohol, tobacco, and other medicines.
Food, alcohol, and tobacco
It is usually not recommended to use the following substance during treatment with this medicine. If it cannot be avoided, your doctor may change the dose or how often you use your medicine.
Certain side effects may worsen if the following substance is used during your treatment. If you cannot avoid using it, your doctor may change the dose or how often you use Mirtazapine.
Other medications may adversely interact with Mirtazapine and may affect the way it works.
The medicines on the following list have the potential to cause significant interactions with Mirtazapine. There may be other medications not listed here which may also cause adverse interaction.
Let your doctor know of all medications you are taking especially if you are already taking other antidepressants.
Using Mirtazapine with any of medicines on the following list is not recommended. Your doctor may still treat you with this antidepressant but may change one or more of the medicines you take. Your dose may also be adjusted.
Usually, it is not recommended to treat patients with Mirtazapine while they are taking any of the medicines on the following list.
If you must take any of these medicines to maintain your health, your doctor may still treat you with Mirtazapine but may change the dose or how often you use any of your medicines.
There is an increase in the risk of certain side effects if this antidepressant is used along with the following medicine. If using it during your treatment for depression is best for you, your doctor may change the dose or how often you use one or both of your medicines.
The following conditions (or history of) may become worse in patients taking this medicine. Use the antidepressant with caution:
The following other condition may worsen due to taking this antidepressant:
Side effects may worsen in patients with the following conditions (or history of):
The medicine should be used with caution in patients who have the following conditions. Side effects may increase due to the slow removal of the medicine from their body.
A doctor may still determine use and dose for children under 18 years of age but must consider the potential risks of using it in this group of patients.
Store Mirtazapine at room temperature, away from direct light, heat, and moisture. Prevent it from freezing.
Keep it away from children and pets.
Throw away medicine when it has expired or is no longer needed.
Follow instructions for safe disposal given to you by your doctor, healthcare professional or your waste disposal agency.
Since its approval by the US Food and Drug Administration (FDA) in 1996, Mirtazapine has been used as a safe and effective drug for treating major depressive disorder (MDD).
However, due to the high risk of life-threatening adverse effects this medicine poses, the FDA requires that Mirtazapine be prescribed with "black-box" warnings to doctors, patients, and healthcare professionals. These warnings relate to the risk of suicide.
The most serious effect of using the medicine is the increased risk of suicidal thoughts and behaviors that threaten the life of a patient. Children, teenagers, and young adults are more likely to be affected in this way.
Patients are especially at risk when they first begin treatment and when their dose is increased or decreased. This requires both doctor and patient to closely monitor side effects and sudden or unusual changes in behavior, feelings, thoughts, and moods.
Major depressive disorder (MDD) itself poses a risk of suicidal thoughts and behaviors even when the patient is not taking antidepressants.
This medicine is known to worsen depression and increase side effects in patients with bipolar disorder or manic depression. It is also known for causing a life-threatening condition called serotonin syndrome and increasing the risk of developing an infection.
Patients are encouraged to let family members and caregivers know what serious side effects to look for and when to seek medical attention on their behalf.