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Mirtazapine is an antidepressant. The way this medication works is still not fully understood. It is thought to positively affect communication between nerve cells in the central nervous system and/or restore chemical balance in the brain.
Mirtazapine is used to treat major depressive disorder.
Mirtazapine may also be used for purposes not listed in this medication guide.
You should not take mirtazapine if you are also taking tryptophan (sometimes called L-tryptophan).
Do not use mirtazapine if you have used an MAO inhibitor or methylene blue injection n the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, tranylcypromine, and others.
Some people have thoughts about suicide when first taking an antidepressant. Your doctor will need to check your progress at regular visits while you are using mirtazapine. Your family or other caregivers should also be alert to changes in your mood or symptoms.
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.
Do not give this medicine to anyone younger than 18 years old without the advice of a doctor. This medicine is not approved for use in children.
It may take up to several weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve after 4 weeks of treatment.
Drinking alcohol can increase certain side effects of mirtazapine.
Mirtazapine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.
Do not stop taking this medicine abruptly. Talk to your doctor before stopping this medicine.
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, rasagiline, selegiline, tranylcypromine, and others.
To make sure mirtazapine is safe for you, tell your doctor if you have ever had:
liver or kidney disease;
seizures or epilepsy;
bipolar disorder (manic depression);
heart problems;
long QT syndrome (in you or a family member); or
low blood pressure or dizzy spells.
Be sure your doctor knows 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. These medicines may interact with mirtazapine and cause a serious condition called serotonin syndrome.
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. Tell your doctor if you have phenylketonuria (PKU).
Take mirtazapine exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.
Take the medicine at the same time each day, usually at bedtime.
Take the regular tablet form of mirtazapine with water.
You may take mirtazapine with or without food.
Remove an orally disintegrating tablet from the package only when you are ready to take the medicine. Place the tablet on your tongue and allow it to dissolve, without chewing. Swallow several times as the tablet dissolves.
It may take a few weeks for your symptoms to improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve after 4 weeks of treatment.
Do not stop using mirtazapine suddenly, or you could have unpleasant withdrawal symptoms (such as dizziness, vomiting, anxiety, confusion, strange dreams, feeling shaky). Ask your doctor how to safely stop using this medicine.
Store at room temperature away from moisture, heat, and light.
Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Overdose symptoms may include confusion, memory problems, drowsiness, and fast heart rate.
Drinking alcohol with mirtazapine can cause side effects.
Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired.
Get emergency medical help if you have signs of an allergic reaction to mirtazapine (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:
feeling restless or being unable to sit still;
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;
fever, chills, sore throat, mouth sores;
changes in weight or appetite;
severe rash, blisters, or swelling on the palms of your hands or the soles of your feet;
a seizure; 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 mirtazapine side effects include:
drowsiness, dizziness;
strange dreams;
dry mouth;
constipation;
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.
Usual Adult Dose for Depression:
Initial dose: 15 mg orally once a day at bedtime
Maintenance dose: 15 to 45 mg orally once a day
Maximum dose: 45 mg/day
Comments:
-May increase the dose every 1 to 2 weeks to a maximum 45 mg/day according to patient response.
-Patients should be periodically reassessed to determine the need for continued use of this drug.
Use: Treatment of major depressive disorder
Using mirtazapine with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.
Tell your doctor about all your current medicines. Many drugs can affect mirtazapine, especially:
cimetidine;
diazepam;
St. John's wort;
tramadol;
tryptophan (sometimes called L-tryptophan);
an antibiotic - clarithromycin, rifampin, rifampicin, telithromycin;
antifungal medicine - itraconazole, ketoconazole;
antiviral medicine to treat HIV/AIDS - indinavir, nelfinavir, ritonavir, saquinavir;
medicine to treat mood disorders, thought disorders, or mental illness - such as lithium, other antidepressants, or antipsychotics;
migraine headache medicine - sumatriptan, rizatriptan, Imitrex, Maxzalt, and others; or
seizure medicine - carbamazepine, phenytoin.
This list is not complete and many other drugs may interact with mirtazapine. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use mirtazapine only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Mirtazapine (www.drugs.com/mirtazapine.html).
Commonly reported side effects of mirtazapine include: severe sedation, constipation, drowsiness, increased serum cholesterol, weight gain, fatigue, insomnia, increased appetite, xerostomia, and decreased appetite. Other side effects include: dizziness, increased serum triglycerides, tremor, dyspepsia, hot flash, palpitations, vertigo, abnormal dreams, bitter taste, decreased libido, and diaphoresis. See below for a comprehensive list of adverse effects.
Applies to mirtazapine: oral tablet, oral tablet disintegrating
Oral route (Tablet; Tablet, Disintegrating)
Antidepressants increased the risk of suicidal thinking and behavior in children, adolescents, and young adults with major depressive disorder and other psychiatric disorders in short-term studies. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared with placebo in adults beyond age 24, and there was a reduction in risk with antidepressants compared with placebo in adults aged 65 or older. This risk must be balanced with the clinical need. Monitor patients 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. Mirtazapine is not approved for use in pediatric patients.
Along with its needed effects, mirtazapine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking mirtazapine:
Less common
Rare
Some side effects of mirtazapine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
Less common
Applies to mirtazapine: oral tablet, oral tablet disintegrating
Very common (10% or more): Somnolence (up to 54%)
Common (1% to 10%): Dizziness, tremor, headache, sedation/drowsiness
Uncommon (0.1% to 1%): Hypesthesia, hypokinesia, vertigo, amnesia, hyperkinesia, paresthesia, lethargy
Rare (0.01% to 0.1%): Syncope, migraine, ataxia, dyskinesia, extrapyramidal syndrome, coordination abnormal, dysarthria, dystonia, reflexes increased, restless legs, akathisia (psychomotor restlessness)
Very rare (less than 0.01%): Vascular headache, cerebral ischemia, aphasia, nystagmus, stupor, dementia, paralysis, grand mal convulsion, hypotonia, taste loss, myoclonus, parosmia
Frequency not reported: Hypertonia, taste perversion, convulsions (insults)
Postmarketing reports: Impaired concentration, cerebrovascular disorder, movement disorders
Very common (10% or more): Dry mouth (up to 25%), constipation (up to 13%)
Common (1% to 10%): Nausea
Uncommon (0.1% to 1%): Abdominal pain, abdominal syndrome acute, vomiting, diarrhea
Rare (0.01% to 0.1%): Abdomen enlarged, eructation, glossitis, nausea and vomiting, gum hemorrhage, stomatitis, colitis, oral hypoesthesia
Very rare (less than 0.01%): Tongue discoloration, ulcerative stomatitis, salivary gland enlargement, increased salivation, intestinal obstruction, pancreatitis, aphthous stomatitis, gastritis, gastroenteritis, oral moniliasis, tongue edema
Frequency not reported: Dyspepsia, flatulence, oral paresthesia, mouth edema
Very common (10% or more): Increased appetite (up to 17%), weight gain (up to 12%)
Uncommon (0.1% to 1%): Anorexia
Rare (0.01% to 0.1%): Dehydration, weight loss
Very rare (less than 0.01%): Gout, acid phosphatase increased, diabetes mellitus, hyponatremia
Frequency not reported: Hypertriglyceridemia
Postmarketing reports: Hypercholesterolemia, hyperlipidemia
Common (1% to 10%): Abnormal dreams, thinking abnormal, confusion
Uncommon (0.1% to 1%): Apathy, depression, agitation, anxiety, insomnia
Rare (0.01% to 0.1%): Delirium, delusions, depersonalization, increased libido, hallucinations, manic reaction/mania, neurosis, hostility, emotional lability, euphoria, paranoid reaction, nightmares/vivid dreams
Very rare (less than 0.01%): Drug dependence, psychotic depression, withdrawal syndrome, serotonin syndrome, aggression
Frequency not reported: Nervousness, decreased libido, suicidal ideation, suicidal behavior, somnambulism
Postmarketing reports: Psychomotor restlessness, drug withdrawal symptoms, paroniria
Common (1% to 10%): Peripheral edema, edema
Uncommon (0.1% to 1%): Hypertension, vasodilation, orthostatic hypotension
Rare (0.01% to 0.1%): Angina pectoris, myocardial infarction, bradycardia, ventricular extrasystoles, hypotension
Very rare (less than 0.01%): Chest pain substernal, atrial arrhythmia, bigeminy, cardiomegaly, phlebitis, left heart failure
Frequency not reported: Chest pain, palpitation, tachycardia, postural hypotension, ECG changes
Postmarketing reports: Ventricular arrhythmia, Torsades de pointes, generalized edema, localized edema
There was a mean increase in heart rate observed in patients given this drug compared to placebo (3.4 bpm versus 0.8 bpm, respectively); however, the clinical significance of this difference is unknown.
Common (1% to 10%): Back pain, myalgia
Uncommon (0.1% to 1%): Myasthenia, arthralgia, twitching
Rare (0.01% to 0.1%): Neck rigidity, neck pain, arthritis, tenosynovitis
Very rare (less than 0.01%): Pathologic fracture, osteoporosis fracture, bone pain, myositis, tendon rupture, arthrosis, bursitis
Postmarketing reports: Increased creatine kinase blood levels, rhabdomyolysis
Common (1% to 10%): Dyspnea
Uncommon (0.1% to 1%): Cough increased, sinusitis
Rare (0.01% to 0.1%): Epistaxis, bronchitis, asthma, pneumonia
Very rare (less than 0.01%): Respiratory/pulmonary embolus, asphyxia, laryngitis, pneumothorax, hiccup
Frequency not reported: Pharyngitis, rhinitis
Postmarketing reports: Pulmonary embolism
Common (1% to 10%): Urinary frequency
Uncommon (0.1% to 1%): Urinary tract infection
Rare (0.01% to 0.1%): Dysuria, urinary incontinence, urinary retention, vaginitis, hematuria, breast pain, amenorrhea, dysmenorrhea, leukorrhea, impotence
Very rare (less than 0.01%): Polyuria, urethritis, metrorrhagia, abnormal ejaculation, breast engorgement, breast enlargement, urinary urgency, menorrhagia
Common (1% to 10%): Asthenia
Uncommon (0.1% to 1%): Malaise, thirst, fatigue
Rare (0.01% to 0.1%): Chills, fever, face edema, ulcer, ear pain, deafness, hyperacusis
Very rare (less than 0.01%): Healing abnormal, partial transitory deafness, otitis media
Frequency not reported: Pain, tinnitus
Common (1% to 10%): Influenza/flu syndrome
Frequency not reported: Infection
Uncommon (0.1% to 1%): Pruritus, rash, exanthema
Rare (0.01% to 0.1%): Photosensitivity reaction, acne, exfoliative dermatitis, dry skin, herpes simplex, alopecia
Very rare (less than 0.01%): Cellulitis, petechia, urticaria, herpes zoster, skin hypertrophy, skin ulcer, seborrhea
Frequency not reported: Sweating
Postmarketing reports: Stevens-Johnson Syndrome, bullous dermatitis, erythema multiforme, toxic epidermal necrolysis, rash (including erythematous and maculopapular)
Rare (0.01% to 0.1%): Eye pain, abnormality of accommodation, conjunctivitis, keratoconjunctivitis, lacrimation disorder, angle-closure glaucoma
Very rare (less than 0.01%): Diplopia, blepharitis
Frequency not reported: Amblyopia
Postmarketing reports: Glaucoma
Rare (0.01% to 0.1%): Cholecystitis, liver function tests abnormal
Very rare (less than 0.01%): Cirrhosis of the liver, AST increased, ALT increased
Postmarketing reports: Jaundice, hepatitis
Rare (0.01% to 0.1%): Kidney calculus, cystitis
Very rare (less than 0.01%): Lymphadenopathy, leukopenia, anemia, thrombocytopenia, lymphocytosis, pancytopenia
Frequency not reported: Bone marrow depression (granulocytopenia, agranulocytosis, aplastic anemia, thrombocytopenia), eosinophilia
Postmarketing reports: Thromboembolic disorder, coagulation disorder
Very rare (less than 0.01%): Goiter, hypothyroidism
Frequency not reported: Inappropriate antidiuretic hormone secretion
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Mirtazapine (www.drugs.com/mirtazapine.html).
February 12, 2020
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