Fluoxetine contraindications and warnings


Following is information on contraindications to the use of Fluoxetine in general, pregnancy & amp; Breastfeeding and children. Please note that the contraindications may vary depending on the dosage form of a drug (eg tablet, syringe, ointment).

When should fluoxetine not be used?

The active substance should not be used at:

  • Hypersensitivity to Fluoxetine
  • concomitant use of MAO inhibitor antidepressant medications. After discontinuation of a MAOI-type medication, wait at least two weeks to ingest the drug.

Only after a careful benefit-risk assessment by a physician, the drug may be used in:

  • seizures in the past
  • bleeding disorders
  • Severe kidney dysfunction.
  • unstable epilepsy.

What should you watch out for during pregnancy and lactation?

Fluoxetine may induce birth defects during pregnancy. Therefore, the drug may be prescribed by the doctor only if absolutely necessary.

However, if the mother is treated with the drug shortly before birth, the newborn child may have the following symptoms:

  • irritability
  • tremor
  • muscle flaccidity
  • continued screaming
  • difficulty in sucking
  • insomnia.

These may be signs of drug withdrawal after birth. In addition, the drug in the child may cause increased blood pressure in the lungs (pulmonary hypertension).

It is well known that fluoxetine and one of its active metabolites are excreted in breast milk. In breastfed infants, side effects have been reported. If treatment with fluoxetine is considered necessary, the doctor may need to advise to give birth. If breast-fed, the doctor must prescribe the lowest effective dose of fluoxetine.

In studies on animals, fluoxetine reduced the quality of the semen. In theory, this could affect fertility, but so far no impact on human fertility has been observed.

What should be considered in children?

The active substance is not suitable for children and adolescents under the age of 18.

Warnings and Precautions

  • Due to the increased risk of suicide, the smallest possible number of tablets should be prescribed at the beginning of treatment with the medication and the patient should be closely monitored by the doctor or family member.
  • If you are taking MAOI-type medication, you should not take the medicine as it may trigger the life-threatening serotonin syndrome.
  • Caution should be exercised in patients who have received electroconvulsive therapy for the past eight weeks, as they do not yet know if there are any unfavorable links with taking the drug.
  • In patients with cardiovascular disease, heart function should be checked regularly.
  • If the medication is not discontinued at a slowly reduced dose, withdrawal symptoms such as dizziness, tremors, anxiety, palpitations and nausea may occur.
  • The drug is not suitable for children and adolescents under the age of 18.
  • Severe Depressed and young adults under the age of 30, despite the treatment, are at particular risk for suicide and need to be monitored carefully.
  • The medicine may increase the risk of bone fractures.
  • impairment of responsiveness and ability to drive.

Sometimes medications release allergic reactions.
If you notice any signs of allergic reaction, tell your doctor or pharmacist immediately.