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Diclofenac / misoprostol Pregnancy and Breastfeeding Warnings

Medically reviewed by Last updated on May 11, 2022.

Diclofenac / misoprostol is also known as: Arthrotec

Diclofenac / misoprostol Pregnancy Warnings

Use is contraindicated

AU TGA pregnancy category: X
US FDA pregnancy category: Not assigned

Risk Summary: Administration of misoprostol to pregnant women can lead to abortion, premature birth, or birth defects. Nonsteroidal anti-inflammatory drugs (NSAIDs) use in pregnant women at 30 weeks gestation and later may cause premature closure of the fetal ductus arteriosus; NSAID use at 20 weeks gestation or later may cause fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment.

-Patients prescribed this drug must be advised of the abortifacient properties and warned not to give this drug to others.
-Women of childbearing potential should have a negative pregnancy test within 2 weeks of beginning therapy and should begin therapy on the second or third day of next normal menstrual period.
-Effective contraceptive measures should be used during therapy.
-Not recommended in women attempting to conceive as may impair female fertility.
-If pregnancy occurs during use of this drug, discontinue treatment and advise the patients of the potential hazards to the fetus.

Administration of misoprostol can cause abortion, premature birth, fetal death, or birth defects, as well as cause induction of labor. This drug should not be used in women of childbearing potential unless the patient requires nonsteroidal anti-inflammatory drugs (NSAID) therapy and the patients is at high risk of developing gastric or duodenal ulceration or developing complications from gastric or duodenal complications associated with NSAID use. NSAIDs used in late pregnancy may cause premature closure of the fetal ductus arteriosus. There are no controlled data in human pregnancy.

US FDA Drug Safety Communication (10-2020): The FDA is requiring a new warning be added to NSAID labeling describing the risk of fetal kidney problems that may result in low amniotic fluid. The FDA is recommending pregnant women avoid NSAID use at 20 weeks gestation or later. Through 2017, the FDA has received 35 reports of low amniotic fluid levels or kidney problems in mothers who took NSAIDs while pregnant. Five newborns died; 2 had kidney failure and confirmed low amniotic fluid, 3 had kidney failure without confirmed low amniotic fluid. The low amniotic fluid started as early as 20 weeks of pregnancy. There were 11 reports of low amniotic fluid levels during pregnancy and the fluid volume returned to normal after the NSAID was stopped. The medical literature has reported low amniotic fluid levels with use of NSAIDs for varying amounts of time, ranging from 48 hours to multiple weeks. Complications of prolonged oligohydramnios may include limb contractures and delayed lung maturation. In some postmarketing cases of impaired neonatal renal function, invasive procedures such as exchange transfusion or dialysis were required. In other cases, the condition was reversible within 3 to 6 days of stopping the NSAID and in these cases reappeared when the same NSAID was restarted.

AU TGA pregnancy category X: Drugs which have such a high risk of causing permanent damage to the fetus that they should not be used in pregnancy or when there is a possibility of pregnancy.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

See references

Diclofenac / misoprostol Breastfeeding Warnings

Two small studies including a total of 22 lactating women found very low levels of misoprostol acid, a biologically active metabolite, in breast milk. The maximum concentration in the breast milk occurred 1 hour after the dose. The data on excretion of diclofenac into breast milk is limited. It does appear to pass in small amounts. Some experts consider this drug to be acceptable during breast feeding, however other agents have more published information and may be preferred, especially when nursing a newborn or preterm infant.

Use is not recommended.

Excreted into human milk: Yes (diclofenac, misoprostol)

Comments: The effects in the nursing infant are unknown; however diarrhea is a recognized side effect of misoprostol and could occur in the infant.

See references

References for pregnancy information

  1. "Product Information. Arthrotec (diclofenac-misoprostol)." Searle (2001):
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Cerner Multum, Inc. "Australian Product Information." O 0
  4. US Food and Drug Administration "FDA recommends avoiding use of NSAIDs in pregnancy at 20 weeks or later because they can result in low amniotic fluid." (2020):

References for breastfeeding information

  1. "Product Information. Arthrotec (diclofenac-misoprostol)." Searle (2001):
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Cerner Multum, Inc. "Australian Product Information." O 0
  4. United States National Library of Medicine "Toxnet. Toxicology Data Network." (2013):

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.