Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The following adverse reactions are described in more detail in other sections of the prescribing information: • Hypersensitivity [see Contraindications (4) ] • Suicidal Thoughts and Behaviors [see Warnings and Precautions (5.1) ] • Agranulocytosis [see Warnings and Precautions (5.2) ] • Serotonin Syndrome [see Contraindications (4) , Warnings and Precautions (5.3) , Drug Interactions (7) ] • Angle-Closure Glaucoma [see Warnings and Precautions (5.4) ] • QT Prolongation and Torsades de Pointes [see Warnings and Precautions (5.5) ] • Increased Appetite and Weight Gain [see Warnings and Precautions (5.6) ] • Somnolence [see Warnings and Precautions (5.7) ] • Activation of Mania or Hypomania [see Warnings and Precautions (5.8) ] • Seizures [see Warnings and Precautions (5.9) ] • Elevated Cholesterol and Triglycerides [see Warnings and Precautions (5.10) ] • Hyponatremia [see Warnings and Precautions (5.11) ] • Transaminase Elevations [see Warnings and Precautions (5.12) ] • Discontinuation Syndrome [see Warnings and Precautions (5.13) ] • Use in Patients with Concomitant Illness [see Warnings and Precautions (5.14) ] Most common adverse reactions (≥5% or greater and twice placebo) were somnolence, increased appetite, weight gain, and dizziness.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Rising Health, LLC at 1-833-395-6928 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The data described below are from clinical trials in which mirtazapine was administered to 2796 patients in phase 2 and 3 clinical studies.
The trials consisted of double-blind controlled and open-label studies, inpatient and outpatient studies, fixed dose, and titration studies.
Adverse Reactions Leading to Discontinuation of Treatment Approximately 16% of the 453 patients who received mirtazapine in U.S.
6-week placebo-controlled clinical trials discontinued treatment due to an adverse reaction, compared to 7% of the 361 placebo-treated patients in those studies.
The most common reactions leading to discontinuation (≥1% and at a rate at least twice that of placebo) are included in Table
Table 2: Adverse Reactions (≥1% and at least twice placebo) Leading to Discontinuation of Mirtazapine in 6-Week Clinical Trials in Patients with MDD Mirtazapine (n=453) Placebo (n=361) Somnolence 10.4% 2.2% Nausea 1.5% 0% Common Adverse Reactions The most common adverse reactions (≥5% and twice placebo) associated with the use of mirtazapine are listed in Table
Table 3: Adverse Reactions (≥5% and twice placebo) in 6-Week U.S.
5 WARNINGS AND PRECAUTIONS • Agranulocytosis: If sore throat, fever, stomatitis or signs of infection occur, along with a low white blood cell count, treatment with mirtazapine should be discontinued and the patient should be closely monitored.
( 5.2 ) • Serotonin Syndrome: Increased risk when co-administered with other serotonergic drugs (e.g., SSRI, SNRI, triptans), but also when taken alone.
If it occurs, discontinue mirtazapine and initiate supportive treatment.
( 2.4 , 4 , 5.3 , 7 ) • Angle-Closure Glaucoma: Angle closure glaucoma has occurred in patients with untreated anatomically narrow angles treated with antidepressants.
( 5.4 ) • QTc Prolongation: Use mirtazapine with caution in patients with risk factors for QTc prolongation.
Like all medications, Mirtazapine can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: