Mirtazapine: Side Effects, Uses & Monitoring
Facts extracted from current FDA product labeling for Mirtazapine. Educational only — not medical advice.
Reported adverse reactions
| Reaction | Highest frequency reported* |
|---|---|
| Dry mouth | 25% |
| Increased appetite | 17% |
| Constipation | 13% |
| Weight gain | 12% |
| Somnolence | 10.4% |
| Asthenia | 8% |
| Dizziness | 7% |
| Flu syndrome | 5% |
| Abnormal dreams | 4% |
| Thinking abnormal | 3% |
| Back pain | 2% |
| Peripheral edema | 2% |
| Myalgia | 2% |
| Tremor | 2% |
| Confusion | 2% |
| Urinary frequency | 2% |
| Nausea | 1.5% |
| Edema | 1% |
| Dyspnea | 1% |
*Highest percentage across placebo-controlled trial tables summarized in current labeling.
Labeled uses
Mirtazapine tablets, USP are indicated for the treatment of major depressive disorder. The efficacy of mirtazapine tablets, USP in the treatment of major depressive disorder was established in six week controlled trials of outpatients whose diagnoses corresponded most closely to the Diagnostic and Statistical Manual of Mental Disorders – 3rd edition (DSM-III) category of major depressive disorder (see CLINICAL PHARMACOLOGY ). A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation. The effectiveness of mirtazapine tablets, USP in hospitalized depressed patients has not been adequately studied. The efficacy of mirtazapine tablets, USP in maintaining a response in patients with major depr…
Medical disclaimer: Always consult a qualified healthcare professional about any medication.