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Home » Drug Information » FDA Approved Drugs » 1996
Medical Areas: Endocrinology | Psychiatry/Psychology | Family Medicine

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Remeron (Mirtazapine)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company: Organon
Approval Status: Approved June 1996
Treatment Area: depression

General Information

Remeron has been approved for the treatment of depression.

Clinical Results

The FDA clearance of Remeron is based on efficacy data from clinical trials involving approximately 3,000 people. Results from placebo and amitriptyline-controlled clinical trials supported the conclusion that Remeron provides effective relief of depression.

Side Effects

Side effects observed in clinical trials were mostly mild and generally have not caused subjects to stop taking Remeron. The commonly reported drug-related side effects in subjects taking Remeron were somnolence, increased appetite, weight gain, and dizziness.

Mechanism of Action

Remeron is the first agent in a new class of anti-depressants. Remeron stimulates norepinephrine and serotonin release while also blocking two serotonin receptors (5-HT2 and 5-HT3).