Seroquel Drug Warnings:

There have been 26 drug regulatory agency warnings from seven countries (Australia, Canada, Denmark, New Zealand, South Africa, United Kingdom and United States) on Seroquel (or quetiapine). 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):

7 warnings on Seroquel causing death or increased risk of death
7 warnings on Seroquel causing cardiovascular disorders
4 warnings on Seroquel causing weight gain
4 warnings on Seroquel causing nervous system disorders
4 warnings on Seroquel causing heart problems
3 warnings on Seroquel causing stroke
3 warnings on Seroquel causing blood disorders
3 warnings on Seroquel causing metabolic disorders
3 warnings on Seroquel causing involuntary movements
2 warnings on Seroquel causing muscle problems
2 warnings on Seroquel causing blood pressure changes or high or low blood pressure
2 warnings on Seroquel causing liver problems
1 warning on Seroquel causing newborn complications (including infant withdrawal symptoms)
1 warning on Seroquel causing allergic reactions
1 warning on Seroquel causing sleep problems
1 warning on Seroquel causing diabetes
1 warning on Seroquel causing risk of fractures
1 warning on Seroquel causing Neuroleptic Malignant Syndrome (a life-threatening neurological disorder)
1 warning on Seroquel causing abnormal bleeding
1 warning on Seroquel causing skin conditions
1 warning on Seroquel causing seizures or convulsions
1 warning on Seroquel causing hallucinations
1 warning on Seroquel causing suicide risk or attempts
1 warning on Seroquel causing dependence
1 warning on Seroquel causing withdrawal reactions

Seroquel Drug Studies:

There have been 47 studies done in 16 countries (Australia, Brazil, Canada, China, Denmark, Finland, France, Italy, Japan, Netherlands, Spain, Switzerland, Taiwan, Turkey, United Kingdom and United States) on Seroquel (or quetiapine). 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):

15 studies on Seroquel causing cardiovascular disorders
12 studies on Seroquel causing death or increased risk of death
7 studies on Seroquel causing heart problems
5 studies on Seroquel causing diabetes
4 studies on Seroquel causing weight gain
4 studies on Seroquel causing metabolic disorders
3 studies on Seroquel causing heart attacks
3 studies on Seroquel causing stroke
2 studies on Seroquel causing nervous system disorders
2 studies on Seroquel causing involuntary movements
2 studies on Seroquel causing lack of efficacy
2 studies on Seroquel causing blood pressure changes or high or low blood pressure
2 studies on Seroquel causing skin conditions
2 studies on Seroquel causing pregnancy complications
2 studies on Seroquel causing pneumonia
1 study on Seroquel causing muscle problems
1 study on Seroquel causing lowered bone mass
1 study on Seroquel causing sedation
1 study on Seroquel causing newborn complications
1 study on Seroquel causing Neuroleptic Malignant Syndrome (a life-threatening neurological disorder)
1 study on Seroquel causing allergic reactions
1 study on Seroquel causing premature birth
1 study on Seroquel causing infant withdrawal symptoms
1 study on Seroquel causing brain shrinkage or other structural brain changes
1 study on Seroquel causing violence
1 study on Seroquel causing homicidal ideation
1 study on Seroquel causing birth defects
1 study on Seroquel causing suicide risk or completed suicide
1 study on Seroquel causing swelling
1 study on Seroquel causing risk of fractures
1 study on Seroquel causing cognitive impairment

Adverse Reaction Reports Filed with the US FDA: There have been 37,268 adverse reactions reported to the US FDA in connection with Seroquel (quetiapine).

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.

• 7,473 cases of diabetes mellitus
• 3,732 cases of type 2 diabetes mellitus
• 3,236 cases of insomnia
• 3,138 cases of pancreatitis (inflammation of the pancreas)
• 2,018 cases of weight increased
• 1,448 cases of somnolence
• 1,296 cases of death
• 1,289 cases of ketoacidosis (build up of the chemical ketone in the blood)
• 1,254 cases of malaise (unease or discomfort)
• 1,197 cases of anxiety

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