Remeron

[Mirtazapine]

Side Effects & Drug Interactions
Preclinical safety data

Mirtazapine induced no effects of clinical relevance in chronic safety studies in rats and dogs or in reproductive toxicity studies in rats and rabbits.

Mirtazapine was not genotoxic in a series of tests for gene mutation and chromosomal and DNA damage. Thyroid gland tumours found in a rat carcinogenicity study and hepatocellular neoplasm found in a mouse carcinogenicity study are considered to be species-specific, non-genotoxic responses associated with long-term treatment with high doses of hepatic enzyme inducers.

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Undesirable effects

Depressed patients display a number of symptoms that are associated with the illness itself. It is therefore sometimes difficult to ascertain which symptoms are a result of the illness itself and which are a result of treatment with Remeron.

System organ
class
Common
(1-10%)
Uncommon
(0. 1 -1%)
Rare
(0. 01 -0. 1%)

Blood and the lymphatic system disorders

Acute bone marrow depression (granulocytopenia, agranulocytosis, aplastic anemia and thrombocytopenia) (see also section 4.4 'Special
warnings and special precautions for use')

Metabolism and nutrition disorders

Increase in appetite and weight gain

Psychiatric disorders

Nightmares/ vivid dreams Mania

Nervous system disorders

Somnolence (which can lead to impaired concentration), generally occurring during the first few weeks of treatment. (N. B. dose reduction generally does not lead to less sedation but can jeopardize antidepressant efficacy). Dizziness Headache Convulsions (insults), tremor, myoclonus Paresthesia

Restless legs

Vascular disorders

(Orthostatic) hypotension

Hepato-biliary disorders

Elevations in serum transaminase activities

Skin and subcutaneous tissue disorders

Exanthema

Musculoskeletal, connective tissue and bone disorders

Arthralgia/ myalgia

General disorders

Generalised or local oedema and accompanying

weight gain

Fatigue