Moclobemide - Side Effects

Side Effects

The incidence of adverse events is not correlated with age, however adverse events occur more often in females than in males. Moclobemide is regarded as a generally safe antidepressant and due to its favorable side effect profile, it can be considered a first-line therapeutic antidepressant. Side effects of moclobemide are exceptionally low, with insomnia, headache and dizziness being the most commonly reported side effects in the initial stages of therapy with moclobemide. Many antidepressants have an adverse effect on sexual function, however, treatment with moclobemide has actually been found to improve sexual function. Moclobemide does not have any adverse effect on cognitive abilities, thus there are no impairments of moclobemide therapy on memory, attention functions nor is ability to drive a motor vehicle affected adversely. In fact moclobemide has been found to improve cognition, especially memory; this is relevant with regard to the elderly as adverse effects on cognition are of particular concern in this population. People with dementia and comorbid depression also show improvements in cognitive impairments; these improvements are unrelated to alleviation of depression. Alcohol related cognitive impairments are also improved by moclobemide. Improvements in cognition also occur in young depressed people after 6 weeks of treatment. There is a mild impairment in psychometric performance in elderly people but none in younger people. Moclobemide, even at high doses of 600 mg, does not impair the ability to drive a motor vehicle. The tolerability of moclobemide is similar in woman and men and it is also well tolerated in the elderly. Moclobemide is tolerated to a similar degree to the SSRI antidepressants, although unlike SSRIs moclobemide does not cause sexual dysfunction and gastrointestinal disturbance is less common. Moclobemide has been found to be superior to tricyclic and irreversible MAOI antidepressants in terms of side effects, as it does not cause anticholinergic, sedative or cardiovascular adverse effects as well as not causing weight gain.

Unlike the irreversible MAOIs there is no evidence of liver toxicity with moclobemide. Moclobemide has a similar efficacy profile compared to other antidepressants but is significantly superior to the tricyclic antidepressants and the classic (unselective or irreversible) MAOIs, in terms of tolerance and safety profile. Moclobemide has little effect on psychomotor functions. Other side effects include, nausea, insomnia, tremor and lightheadedness; orthostatic hypotension is uncommon even among the elderly. Behavioural toxicity or other impairments relating to everyday living does not occur with moclobemide, except in doses of 400 mg of higher, peripheral reaction time may be impaired. Peripheral oedema has been associated with moclobemide.

Some other side effects include, nausea, stimulation, migraine, disorientation, sedation, agitation and diarrhea. Over 80 percent of side effects are transient disappearing within 2 weeks of treatment. tiredness, headache, restlessness, nervousness and sleep disturbances have been described as side effects from moclobemide therapy. A paradoxical worsening of depression has been reported in some individuals in several studies, and reports of suicidal ideation and suicide as an adverse effect have been reported as a rare adverse effect of moclobemide. Overall, antidepressants decrease the risk of suicide. Moclobemide is believed to have only small proconvulsant effects; however rarely seizures may occur. Hypertension, has been reported to occur very rarely with moclobemide therapy.

Moclobemide is relatively well tolerated. Severe side effects are infrequent. The side effect profile is as follows:

• Blood and blood-forming-organs: Isolated cases of bone-marrow-damage.
• Allergic Reactions/Hypersensitivity: Occasionally isolated urticaria without other symptoms, isolated cases of anaphylaxis involving urticaria, angioedema, asthma, and rapid fall in blood pressure.
• Psychiatric Reactions: Preexisting schizophrenia may exacerbate under moclobemide therapy (see under Cautions).
• Central and Peripheral Nervous System: infrequent peripheral neuropathy.
• Eyes: Infrequent is blurred vision.
• Cardiovascular: Changes in blood pressure such as hypotension are infrequent.
• Gastro-Intestinal Tract: Dry mouth, infrequently stomach upset, heartburn, diarrhea, and constipation.
• Skin: Occasionally rash, pruritus and redness of skin.
• Breast: Rarely secretion of milk in both sexes (due to elevated prolactin levels) and breast enlargement.