Remeron SolTab
- Generic Name: mirtazapine
- Brand Name: Remeron SolTab
Remeron SolTab (Mirtazapine) side effects drug center
Remeron SolTab Side Effects Center
What Is Remeron SolTab?
Remeron SolTab (mirtazapine) is an antidepressant used to treat major depressive disorder. Remeron SolTab is available in generic form.
What Are Side Effects of Remeron SolTab?
Common side effects of Remeron SolTab include:
- dizziness,
- drowsiness,
- lightheadedness,
- increased appetite,
- weight gain,
- dry mouth, or
- constipation
Rarely, patients younger than 24 years old may have suicidal thoughts when taking an antidepressant such as Remeron SolTab. Tell your doctor if this occurs.
Dosage for Remeron SolTab
The recommended starting dose for Remeron SolTab Orally Disintegrating Tablets is 15 mg/day, administered in a single dose, preferably in the evening prior to sleep.
What Drugs, Substances, or Supplements Interact with Remeron SolTab?
Remeron SolTab may interact with cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety. Tell your doctor all medications and supplements you use.
Remeron SolTab During Pregnancy and Breastfeeding
Remeron SolTab should be used only when prescribed during pregnancy. Discuss the risks and benefits with your doctor. If this medication is used during the last 3 months of pregnancy, infrequently a newborn may develop symptoms including feeding or breathing difficulties, seizures, muscle stiffness, jitteriness or constant crying. Do not stop taking this medication unless your doctor directs you to do so. Report any such symptoms to your doctor. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.
Additional Information
Our Remeron SolTab (mirtazapine) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
Remeron SolTab Consumer Information
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.
Read the entire detailed patient monograph for Remeron SolTab (Mirtazapine)
Remeron SolTab Professional Information
SIDE EFFECTS
The following adverse reactions are described in more detail in other sections of the prescribing information:
- Hypersensitivity [see CONTRAINDICATIONS]
- Suicidal Thoughts and Behaviors [see WARNINGS AND PRECAUTIONS]
- Agranulocytosis [see WARNINGS AND PRECAUTIONS]
- Serotonin Syndrome [see CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS, DRUG INTERACTIONS]
- Angle-Closure Glaucoma [see WARNINGS AND PRECAUTIONS]
- QT Prolongation and Torsades de Pointes [see WARNINGS AND PRECAUTIONS]
- Increased Appetite and Weight Gain [see WARNINGS AND PRECAUTIONS]
- Somnolence [see WARNINGS AND PRECAUTIONS]
- Activation of Mania or Hypomania [see WARNINGS AND PRECAUTIONS]
- Seizures [see WARNINGS AND PRECAUTIONS]
- Elevated Cholesterol and Triglycerides [see WARNINGS AND PRECAUTIONS]
- Hyponatremia [see WARNINGS AND PRECAUTIONS]
- Transaminase Elevations [see WARNINGS AND PRECAUTIONS]
- Discontinuation Syndrome [see WARNINGS AND PRECAUTIONS]
- Use in Patients with Concomitant Illness [see WARNINGS AND PRECAUTIONS]
Clinical Trial Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The data described below are from clinical trials in which REMERON/REMERONSolTab was administered to 2796 patients in phase 2 and 3 clinical studies. The trials consisted of double-blind controlled and open-label studies, inpatient and outpatient studies, fixed dose, and titration studies.
Adverse Reactions Leading To Discontinuation Of Treatment
Approximately 16% of the 453 patients who received REMERON in U.S. 6-week placebo-controlled clinical trials discontinued treatment due to an adverse reaction, compared to 7% of the 361 placebo-treated patients in those studies. The most common reactions leading to discontinuation (≥1% and at a rate at least twice that of placebo) are included in Table 2.
Table 2: Adverse Reactions (≥1% and at least twice placebo) Leading to Discontinuationof REMERON in 6-Week Clinical Trials in Patients with MDD
| REMERON (n=453) | Placebo (n=361) | |
| Somnolence | 10.4% | 2.2% |
| Nausea | 1.5% | 0% |
Common Adverse Reactions
The most common adverse reactions (≥5% and twice placebo) associated with the use of REMERON are listed in Table 3.
Table 3: Adverse Reactions (≥5% and twice placebo) in 6-Week U.S. Clinical Trials of REMERON in Patients with MDD
| REMERON (n=453) | Placebo (n=361) | |
| Somnolence | 54% | 18% |
| Increased Appetite | 17% | 2% |
| Weight Gain | 12% | 2% |
| Dizziness | 7% | 3% |
Table 4 enumerates adverse reactions that occurred in ≥1% of REMERON-treated patients, and were more frequent than the placebo-treated patients, who participated in 6-week, U.S. placebo-controlled trials in which patients were dosed in a range of 5 to 60 mg/day. This table shows the percentage of patients in each group who had at least 1 episode of an adverse reaction at some time during their treatment.
Table 4: Adverse Reactions (≥1% and greater than placebo) in 6-Week U.S. Clinical Studies of Remeron in Patients with MDD
| REMERON (n=453) | Placebo (n=361) | |
| Body as a Whole | ||
| Asthenia | 8% | 5% |
| Flu Syndrome | 5% | 3% |
| Back Pain | 2% | 1% |
| Digestive System | ||
| Dry Mouth | 25% | 15% |
| Increased Appetite | 17% | 2% |
| Constipation | 13% | 7% |
| Metabolic and Nutritional Disorders | ||
| Weight Gain | 12% | 2% |
| Peripheral Edema | 2% | 1% |
| Edema | 1% | 0% |
| Musculoskeletal System | ||
| Myalgia | 2% | 1% |
| Nervous System | ||
| Somnolence | 54% | 18% |
| Dizziness | 7% | 3% |
| Abnormal Dreams | 4% | 1% |
| Thinking Abnormal | 3% | 1% |
| Tremor | 2% | 1% |
| Confusion | 2% | 0% |
| Respiratory System | ||
| Dyspnea | 1% | 0% |
| Urogenital System | ||
| Urinary Frequency | 2% | 1% |
ECG Changes
The electrocardiograms for 338 patients who received REMERON and 261 patients who received placebo in 6-week, placebo-controlled trials were analyzed. REMERON was associated with a mean increase in heart rate of 3.4 bpm, compared to 0.8 bpm for placebo. The clinical significance of these changes is unknown.
Other Adverse Reactions Observed During The Premarketing Evaluation Of REMERON
The following list does not include reactions: 1) already listed in previous tables or elsewhere in labeling, 2) for which a drug cause was remote, 3) which were so general or excessively specific so as to be uninformative, 4) which were not considered to have significant clinical implications, or 5) which occurred at a rate equal to or less than placebo.
Adverse reactions are categorized by body system according to the following definitions: frequent adverse reactions are those occurring in at least 1/100 patients; infrequent adverse reactions are those occurring in 1/100 to 1/1000 patients; rare adverse reactions are those occurring in fewer than 1/1000 patients.
Body as a Whole: frequent: malaise, abdominal pain, abdominal syndrome acute; infrequent: chills, fever, face edema, ulcer, photosensitivity reaction, neck rigidity, neck pain, abdomen enlarged; rare: cellulitis, chest pain substernal.
Cardiovascular System: frequent: hypertension, vasodilatation; infrequent: angina pectoris, myocardial infarction, bradycardia, ventricular extrasystoles, syncope, migraine, hypotension; rare: atrial arrhythmia, bigeminy, vascular headache, pulmonary embolus, cerebral ischemia, cardiomegaly, phlebitis, left heart failure.
Digestive System: frequent: vomiting, anorexia; infrequent: eructation, glossitis, cholecystitis, nausea and vomiting, gum hemorrhage, stomatitis, colitis, liver function tests abnormal; rare: tongue discoloration,ulcerative stomatitis, salivary gland enlargement, increased salivation, intestinal obstruction, pancreatitis, aphthous stomatitis, cirrhosis of liver, gastritis, gastroenteritis, oral moniliasis, tongue edema.
Endocrine System: rare: goiter, hypothyroidism.Hemic and Lymphatic System: rare: lymphadenopathy, leukopenia, petechia, anemia, thrombocytopenia, lymphocytosis, pancytopenia.
Metabolic and Nutritional Disorders: frequent: thirst; infrequent: dehydration, weight loss; rare: gout, SGOT increased, healing abnormal, acid phosphatase increased, SGPT increased, diabetes mellitus, hyponatremia.
Musculoskeletal System: frequent: myasthenia, arthralgia; infrequent: arthritis, tenosynovitis; rare: pathologic fracture, osteoporosis fracture, bone pain, myositis, tendon rupture, arthrosis, bursitis.
Nervous System: frequent: hypesthesia, apathy, depression, hypokinesia, vertigo, twitching, agitation, anxiety, amnesia, hyperkinesia, paresthesia; infrequent: ataxia, delirium, delusions, depersonalization, dyskinesia, extrapyramidal syndrome, libido increased, coordination abnormal, dysarthria, hallucinations, manic reaction, neurosis, dystonia, hostility, reflexes increased, emotional lability, euphoria, paranoid reaction; rare: aphasia, nystagmus, akathisia (psychomotor restlessness), stupor, dementia, diplopia, drug dependence, paralysis, grand mal convulsion, hypotonia, myoclonus, psychotic depression, withdrawal syndrome, serotonin syndrome.
Respiratory System: frequent: cough increased, sinusitis; infrequent: epistaxis, bronchitis, asthma, pneumonia; rare: asphyxia, laryngitis, pneumothorax, hiccup.
Skin and Appendages: frequent: pruritus, rash; infrequent: acne, exfoliative dermatitis, dry skin, herpes simplex, alopecia; rare: urticaria, herpes zoster, skin hypertrophy, seborrhea, skin ulcer.
Special Senses: infrequent: eye pain, abnormality of accommodation, conjunctivitis, deafness, keratoconjunctivitis, lacrimation disorder, angle-closure glaucoma, hyperacusis, ear pain; rare: blepharitis, partial transitory deafness, otitis media, taste loss, parosmia.
Urogenital System: frequent: urinary tract infection; infrequent: kidney calculus, cystitis, dysuria, urinary incontinence, urinary retention, vaginitis, hematuria, breast pain, amenorrhea, dysmenorrhea, leukorrhea, impotence; rare: polyuria, urethritis, metrorrhagia, menorrhagia, abnormal ejaculation, breast engorgement, breast enlargement, urinary urgency.
Postmarketing Experience
The following adverse reactions have been identified during post-approval use of REMERON. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Cardiac disorders: ventricular arrhythmia (Torsades de Pointes)
Endocrine disorders: hyperprolactinemia (and related symptoms, e.g., galactorrhea and gynecomastia)
Musculoskeletal and connective tissue disorders: increased creatine kinase blood levels and rhabdomyolysis
Psychiatric disorders: somnambulism (ambulation and other complex behaviors out of bed)
Skin and subcutaneous tissue disorders: severe skin reactions, including Stevens-Johnson syndrome, bullous dermatitis, erythema multiforme and toxic epidermal necrolysis
Read the entire FDA prescribing information for Remeron SolTab (Mirtazapine)
&Copy; Remeron SolTab Patient Information is supplied by Cerner Multum, Inc. and Remeron SolTab Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.