Remeron Drug Warnings:

There have been 18 drug regulatory agency warnings from four countries (Australia, Canada, Japan and United States) and the European Union on Remeron (or mirtazapine). These include the following (note that some warnings cite more than one side effect, so the list below may not be equal to the total number of warnings):

8 warnings on Remeron causing suicide risk or suicidal behavior
4 warnings on Remeron causing Serotonin Syndrome
3 warnings on Remeron causing hostility or aggression
3 warnings on Remeron causing agitation
3 warnings on Remeron causing anxiety
2 warnings on Remeron causing involuntary movements
2 warnings on Remeron causing abnormal behavior
2 warnings on Remeron causing muscle problems
1 warning on Remeron causing newborn complications
1 warning on Remeron causing birth defects
1 warning on Remeron causing eye problems
1 warning on Remeron causing self-harm
1 warning on Remeron causing withdrawal reactions
1 warning on Remeron causing nervous system disorders
1 warning on Remeron causing violence
1 warning on Remeron causing cardiovascular disorders
1 warning on Remeron causing mania or psychosis
1 warning on Remeron causing sleep problems
1 warning on Remeron causing irritability
1 warning on Remeron causing blood disorders
1 warning on Remeron causing heart problems
1 warning on Remeron having lack of efficacy
1 warning on Remeron causing Neuroleptic Malignant Syndrome (a life-threatening neurological disorder)
1 warning on Remeron causing seizures or convulsions
1 warning on Remeron causing gastrointestinal problems
1 warning on Remeron causing skin conditions
1 warning on Remeron causing liver problems
1 warning on Remeron causing hallucinations
1 warning on Remeron causing weight gain

Remeron Drug Studies:

There have been 24 studies done in 16 countries (Australia, Brazil, Canada, China, France, Germany, Italy, Netherlands, Portugal, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom and United States) on Remeron (or mirtazapine). These include the following (note that some studies cite more than one side effect, so the list below may not be equal to the total number of studies):

7 studies on Remeron causing suicide risk or attempts
3 studies on Remeron causing abnormal bleeding
3 studies on Remeron causing gastrointestinal problems
3 studies on Remeron having lack of efficacy
2 studies on Remeron causing self-harm
2 studies on Remeron causing nervous system disorders
2 studies on Remeron causing involuntary movements
2 studies on Remeron causing skin conditions
2 studies on Remeron causing cardiovascular disorders
1 study on Remeron causing newborn complications
1 study on Remeron causing pregnancy complications
1 study on Remeron causing risk of fractures
1 study on Remeron causing premature birth
1 study on Remeron causing risk of falls
1 study on Remeron causing violence
1 study on Remeron causing weight gain
1 study on Remeron causing diabetes
1 study on Remeron causing homicide or homicidal ideation
1 study on Remeron causing liver problems
1 study on Remeron causing allergic reactions
1 study on Remeron causing heart problems
1 study on Remeron causing stroke
1 study on Remeron causing death or increased risk of death
1 study on Remeron causing seizures
1 study on Remeron causing impaired driving
1 study on Remeron causing sleep problems

Top Reactions for All Ages: There have been 4,274 adverse reactions reported to the US FDA in connection with Remeron.

The FDA estimates that less than 1% of all serious events are ever reported to it, so the actual number of side effects occurring are most certainly higher.

• 244 cases of completed suicides
• 202 cases of confusion
• 188 cases of depression
• 184 cases of insomnia
• 184 cases of somnolence (sleepiness)
• 173 cases of hyponatraemia (sodium deficiency)
• 173 cases of overdose
• 163 cases of suicide attempt
• 160 cases of falls
• 159 cases of anxiety

Documented Side Effects of Remeron:
Source: Physicians Desk Reference, National Institutes of Health’s Medline Plus, and/or the drug label.