Chemical formula: C₁₈H₂₀N₂ Molecular mass: 264.365 g/mol PubChem compound: 4184
Do not use during pregnancy unless there are compelling reasons. There is no evidence of safety in human pregnancy. Animal studies have not shown hazard.
Mianserin is contraindicated during breast feeding. Breast feeding should be discontinued if treatment with mianserin is considered essential.
The most commonly occurring side effect is drowsiness, particularly during the first few days of treatment. Patients should be warned of the possible hazard in driving or operating machinery. Any drowsiness may be potentiated by alcohol.
The frequency and severity of depression-related symptoms such as blurred vision, dry mouth and constipation do not usually increase during treatment with mianserin; in fact an actual decrease has been observed in many cases.
Adverse events are listed below by system organ class and frequency. Frequencies are defined as: very common (>1/10), common (>1/100, <1/10), uncommon (>1/1000, <1/100), rare (>1/10,000, <1/1000) very rare (<1/10,000) and not known (cannot be estimated from available data).
Not known: Bone marrow depression, usually presenting as granulocytopenia or agranulocytosis has been reported during treatment with mianserin1. Leucopenia and aplastic anaemia.
Not known: Hyponatraemia2
Not known: Suicidal ideation, suicidal behaviour3. Psychotic manifestations, including mania and paranoid delusions, may be exacerbated during antidepressant therapy. Interference with sexual function in adults4, withdrawal symptoms in adults4, withdrawal symptoms (e.g. neuro-muscular irritability) in neonates whose mothers received tricyclic or bridged tricyclic antidepressants during pregnancy4. Hypomania has also been reported at therapeutic dosage and under such circumstances treatment should be withdrawn.
Not known: Dizziness, tremor. Convulsions have also been reported at therapeutic dosage and under such circumstances treatment should be withdrawn.
Not known: Postural hypotension
Not known: Disturbances of liver function. Jaundice, usually mild, has also been reported at therapeutic dosage and under such circumstances treatment should be withdrawn.
Not known: Skin rash, sweating
Not known: Arthralgia, polyarthropathy, arthritis
Not known: Breast disorders (gynaecomastia, nipple tenderness and non- puerperal lactation).
Not known: Oedema
1 These reactions have occurred most commonly after 4-6 weeks and were generally reversible on stopping treatment. A full blood count is recommended every four weeks during the first three months of treatment. In addition, monitoring of the patient’s clinical condition should continue and if a patient develops fever, sore throat, stomatitis or other signs of infection, treatment should be stopped and a full blood count obtained. These adverse reactions have been observed in all age groups but appear to be more common in the elderly.
2 Usually in the elderly, and possibly due to inappropriate secretion of antidiuretic hormone, hyponatraemia has been associated with all types of antidepressants and should be considered in all patients who develop drowsiness, confusion or convulsions whilst taking an antidepressant.
3 Cases of suicidal ideation and suicidal behaviours have been reported during mianserin therapy or early after treatment discontinuation.
4 Although not reported with mianserin, these adverse events can occur with tricyclics and bridged tricyclics.
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