Prozac and Pregnancy: Is there Any Danger for the Fetus?

Prozac (Fluoxetine) refers to antidepressants that inhibit serotonin reuptake (serotonergic antidepressants, serotonin reuptake inhibitors). The drug is effective in the treatment of depression and anxiety disorders. It improves mood, reduces the feeling of tension, anxiety, fear. But are Prozac and pregnancy compatible?

The main advantage of Prozac over traditional tricyclic antidepressants (the so-called classic antidepressants) is the reduced side effects due to the selective mechanism of action. When used, fluoxetine is better tolerated and, according to many studies, is more effective than classic antidepressants, although the results of the comparison are not completely straightforward.

Advantages and Disadvantages of Serotonergic Antidepressants

Benefits of antidepressants that selectively suppress serotonin reuptake:

  • Effective therapy for both anxiety and depressive symptoms
  • Safety
  • Minimal cardiovascular risk
  • No addiction
  • The possibility of long-term therapy
  • Prophylactic therapy – prevention of disorders
  • The effect lasts as long as treatment continues
  • Long-term treatment allows you to avoid relapses

Anxiety disorders are often accompanied by alcohol and psychoactive substances addiction. In such cases, it is not recommended to prescribe benzodiazepines and antidepressants that selectively inhibit serotonin reuptake become mainline drugs in the treatment of depression since they do not cause drug dependence.

Disadvantages of Serotonergic Antidepressants

  • Sexual side effects
  • Sometimes there is a need to gradually increase the dose to the maximum amount to achieve a therapeutic effect
  • It may be difficult to determine the early onset of the reaction to treatment
  • Slow, gradual improvement over weeks or months
  • Frequent occurrence of overstimulation phenomena – irritability, insomnia, nervousness, increased anxiety and panic symptoms

The disadvantage of a non-medical nature is the lower economic affordability of drugs of this group (price), as they are taken for a long time, as well as the absence of injectable forms for most drugs.


  • Obsessive compulsive disorder
  • Depression of various origins
  • Premenstrual dysphoria
  • Bulimic neurosis


  • Hypersensitivity to medication components
  • Severe disorders of kidney function and liver
  • Simultaneous reception of monoamine oxidase inhibitors and within 14 days after their cancellation, thioridazine, pimozide
  • Atony of the bladder
  • Children’s age up to 18 years
  • Pregnancy
  • Lactation

With caution: suicidal mood, epilepsy, diabetes, excessive weight loss, Parkinson’s disease.


Prozac and Pregnancy (+ Breastfeeding)

Prozac during pregnancy should be prescribed only in case of emergency. When fluoxetine is used during pregnancy, an increased risk of preterm birth, developmental abnormalities, and low adaptation of newborns (including respiratory distress, cyanosis, excitability) are noted.

The category of action on the fetus by the FDA – is C.

What concerns breastfeeding, it should be stopped at the time of treatment (fluoxetine passes into breast milk of lactating women).

Prozac and Pregnancy (The First Trimester)

A sufficient number of controlled studies on the safety of Prozac and pregnancy during the first trimester has not been conducted, and the results of some published epidemiological studies are contradictory. More than 10 cohort studies and case-control studies did not reveal an increase in the likelihood of congenital malformations.

At the same time, a prospective cohort study conducted by the European Network of Teratology Information Services suggests an increased risk of congenital cardiovascular defects in newborns whose mothers (n = 253) used fluoxetine during the first trimester of pregnancy compared to newborns whose mothers (n = 1359) did not take fluoxetine.

At the same time, a specific group of cardiovascular malformations was not identified and it was not possible to establish a reliable causal relationship between Prozac intake during the first trimester of pregnancy and an increase in the risk of fetal development abnormalities.

Fluoxetine Use in the iII Trimester of Pregnancy

The use of serotonin and noradrenaline reuptake inhibitors, as well as SSRIs, including fluoxetine, at the end of the third trimester of pregnancy, may lead to the development of complications in newborns.

Also, there are reports of the development of such pathological conditions as respiratory distress syndrome of the newborn, apnea, convulsions, lability of body temperature, hypoglycemia, low or high blood pressure, vomiting, the difficulty of adequate nutrition, cyanosis, hyperreflexia, tremor, nervous irritability, excitability, constant crying. These violations may be a manifestation of the toxic effects of serotonin noradrenaline reuptake inhibitors and SSRIs or can be a consequence of their withdrawal syndrome.

Study of Fluoxetine Teratogenicity in Animals

With the introduction of fluoxetine, in doses exceeding 12.5 mg/kg per day to pregnant female rats, as well as in doses exceeding 15 mg/kg per day to pregnant female rabbits (respectively 1.5 and 3.6 times higher than the maximum dose recommended for humans – 80 mg / m2), there was no reliable data indicating the teratogenicity of fluoxetine during the process of organogenesis.

However, data obtained from other tests in rats indicate an increase in the number of stillbirths, a decrease in the weight of the newborn, and an increase in the mortality of the newborn infant rats within 7 days after birth with fluoxetine administered at a dose of 12 mg/kg per day (1.5 times higher dose than that recommended for humans) during pregnancy and at a dose of 7.5 mg/kg per day (90% of the maximum dose recommended for humans) during pregnancy and lactation.

At the same time, no signs of neurotoxicity were found in surviving newborn female rats who received 12 mg/kg of fluoxetine per day during pregnancy. The dose of fluoxetine 5 mg/kg per day (60% of the maximum dose recommended for humans) was determined not to increase the mortality of newborn animals.

Side Effects

  • Dizziness, headache, fatigue, asthenia, sleep disturbances, motor agitation, tremor, agitation, increased suicidal tendencies, anxiety, mania or hypomania.
  • Decreased appetite, dry mouth or hypersalivation, nausea, vomiting, taste disturbance, diarrhea.
  • Allergic reactions in the form of skin rash, itching, urticaria, myalgia, arthralgia, fever.
  • Urinary incontinence, urinary retention, dysmenorrhea, vaginitis, decreased sexual desire, impaired sexual function in men (delayed ejaculation).
  • Increased sweating, tachycardia, impaired visual acuity, weight loss, systemic disorders of the lungs, kidneys or liver, vasculitis.

Attention! Description of the drug is a simplified version of the official instructions for use. Keep in mind that information about the drug is provided solely for informational purposes and should not be used as a guide to self-treatment.