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).
Blood and lymphatic disorders Not known:
Bone marrow depression, usually presenting as granulocytopenia or agranulocytosis has been reported during treatment with mianserin1. Leucopenia and aplastic anaemia.
Metabolism and nutrition disorders Not known:
Hyponatraemia2 Psychiatric disorders Not known: Suicidal ideation, suicidal behaviour3. Psychotic manifestations, including mania and paranoid delusions, may be exacerbated during antidepressant therapy. 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Hypomania has also been reported at therapeutic dosage and under such circumstances treatment should be withdrawn.
Nervous system disorders Not known:
Dizziness, tremor. Convulsions have also been reported at therapeutic dosage and under such circumstances treatment should be withdrawn.
Vascular disorders Not known:
Postural hypotension Hepatobiliary disorders Not known: Disturbances of liver function. Jaundice, usually mild, has also been reported at therapeutic dosage and under such circumstances treatment should be withdrawn.
Skin and subcutaneous tissue disorders Not known:
Skin rash, sweating Musculoskeletal and connective tissue disorders Not known: Arthralgia, polyarthropathy, arthritis Reproductive system and breast disorders Not known: Breast disorders (gynaecomastia, nipple tenderness and non- puerperal lactation).
General disorders and administration site conditions Not known:
Oedema 1These 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. 4). These adverse reactions have been observed in all age groups but appear to be more common in the elderly.
2Usually 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.
4). 4Although not reported with mianserin, these adverse events can occur with tricyclics and bridged tricyclics Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard.