Fluoxetine

Warning

Suicidal thoughts and behaviors in children, adolescents, and young adults

Contraindications

• Monoamine oxidase inhibitors (MAOIs)
• Pimozide
• Thioridazine

Adverse Reactions

• Abnormal dreams
• Abnormal ejaculation
• Anorexia
• Anxiety
• Asthenia
• Diarrhea
• Dry mouth
• Dyspepsia
• Flu syndrome
• Impotence
• Insomnia
• Libido decreased
• Nausea
• Nervousness
• Pharyngitis
• Rash
• Sinusitis
• Somnolence
• Sweating
• Tremor
• Vasodilatation
• Yawn

General Guidance

Dose adjustments may be necessary for patients with hepatic impairment, the elderly, and those with concurrent disease or multiple concomitant medications.

Pregnancy

• Fluoxetine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
• Neonates exposed to fluoxetine in the third trimester have developed complications requiring prolonged hospitalization.

Nursing Mothers

• Fluoxetine is excreted in human milk, and nursing while on fluoxetine is not recommended.
• Infants exposed to fluoxetine via breast milk have developed adverse reactions such as crying, sleep disturbance, vomiting, and watery stools.

Pediatric Use

• The safety and effectiveness of fluoxetine in pediatric patients < 8 years of age have not been established.
• Fluoxetine has been associated with decreased weight gain and decreased alkaline phosphatase levels in pediatric patients.

Geriatric Use

• U.S. fluoxetine clinical trials included 687 patients ≥ 65 years of age and 93 patients ≥ 75 years of age.
• No overall differences in safety or effectiveness were observed between these subjects and younger subjects.