Remeron SolTab Side Effects
Generic name: mirtazapine
Medically reviewed by Drugs.com. Last updated on Apr 21, 2023.
Note: This document contains side effect information about mirtazapine. Some dosage forms listed on this page may not apply to the brand name Remeron SolTab.
Applies to mirtazapine: oral tablet, oral tablet disintegrating.
Warning
Oral route (Tablet; Tablet, Disintegrating)
Suicidal Thoughts and BehaviorsIncreased risk of suicidal thoughts and behavior in pediatric and young adult patients taking antidepressants. Closely monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors. Mirtazapine is not approved for use in pediatric patients..
Serious side effects of Remeron SolTab
Along with its needed effects, mirtazapine (the active ingredient contained in Remeron SolTab) 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
- Decreased or increased movement
- mood or mental changes, including abnormal thinking, agitation, anxiety, confusion, and feelings of not caring
- skin rash
- swelling
- trouble breathing
Rare
- Change in menstrual cycle (periods)
- chills
- decreased sexual ability
- fever
- menstrual pain
- mood or mental changes, including anger, feelings of being outside the body, mood swings, and unusual excitement
- mouth sores
- seeing, hearing, or feeling things that are not there
- seizures
- sore throat
Incidence not known
- Black, tarry stools
- blistering, peeling, loosening of skin
- chest pain
- fainting
- hives, itching, skin rash
- irregular or slow heart rate
- joint or muscle pain
- painful or difficult urination
- red, irritated eyes
- red skin lesions, often with a purple center
- sore throat
- sores, ulcers, or white spots on the lips or in the mouth
- swollen glands
- unusual bleeding or bruising
- unusual tiredness or weakness
Other side effects of Remeron SolTab
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
- Constipation
- dizziness
- drowsiness
- dry mouth
- increased appetite
- weight gain
Less common
- Abnormal dreams
- back pain
- dizziness or fainting when getting up suddenly from a lying or sitting position
- increased need to urinate
- increased sensitivity to touch
- increased thirst
- low blood pressure
- muscle pain
- nausea
- sense of constant movement of self or surroundings
- stomach pain
- trembling or shaking
- vomiting
Incidence not known
- Painful or prolonged erection of the penis
- swelling of the breasts or unusual milk production
For Healthcare Professionals
Applies to mirtazapine: oral tablet, oral tablet disintegrating.
Nervous system
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[Ref]
Gastrointestinal
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[Ref]
Metabolic
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[Ref]
Psychiatric
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[Ref]
Cardiovascular
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[Ref]
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.[Ref]
Musculoskeletal
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[Ref]
Respiratory
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[Ref]
Genitourinary
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[Ref]
Other
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[Ref]
Immunologic
Common (1% to 10%): Influenza/flu syndrome
Frequency not reported: Infection[Ref]
Dermatologic
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)[Ref]
Ocular
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[Ref]
Hepatic
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[Ref]
Renal
Rare (0.01% to 0.1%): Kidney calculus, cystitis[Ref]
Hematologic
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[Ref]
Endocrine
Very rare (less than 0.01%): Goiter, hypothyroidism
Frequency not reported: Inappropriate antidiuretic hormone secretion[Ref]
Frequently asked questions
More about Remeron SolTab (mirtazapine)
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References
1. Product Information. Remeron (mirtazapine). Organon. 2001.
2. Cerner Multum, Inc. UK Summary of Product Characteristics.
3. Cerner Multum, Inc. Australian Product Information.
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Some side effects may not be reported. You may report them to the FDA.