CHEARS

Facts about NSAIDs 

• NSAIDs are a class of medicines available by prescription and over-the-counter (OTC). They are some of the most commonly used medicines for pain and fever. 

• NSAIDs are used to treat medical conditions such as arthritis, menstrual cramps, headaches, colds, and the flu. 

• NSAIDs work by blocking the production of certain chemicals in the body that cause inflammation. 

• NSAIDS are available alone and combined with other medicines. Examples of NSAIDs include aspirin, ibuprofen, naproxen, diclofenac, and celecoxib. See Table 1 for a list of NSAIDs. 

• Common side effects of NSAIDs include stomach pain, constipation, diarrhea, gas, heartburn, nausea, vomiting, and dizziness

Additional Information for Pregnant Women 

• Using pain-relieving and fever-reducing nonsteroidal anti-inflammatory drugs (NSAIDs) around 20 weeks or later in pregnancy may cause kidney problems in the unborn baby, which can lead to low levels of amniotic fluid that surrounds the baby. This fluid provides a protective cushion and helps the unborn babies’ lungs, digestive system, and muscles develop. Complications can occur with low levels of this fluid. 

• If you are pregnant, do not use NSAIDs at 20 weeks or later in pregnancy unless specifically advised to do so by your health care professional because these medicines may cause problems in your unborn baby. 

• Many over-the-counter (OTC) medicines contain NSAIDs, including those used for pain, colds, flu, and insomnia, so it is important to read the Drug Facts labels to find out if the medicines contain NSAIDs.

• Talk to your health care professional or pharmacist if you have questions or concerns about NSAIDs or which medicines contain them. 

Among the 35 cases of low amniotic fluid levels or kidney problems reported to FDA* through 2017, all were serious. This number includes only cases submitted to FDA, so there may be additional cases. Two newborns who died had kidney failure and confirmed low amniotic fluid when mothers took NSAIDs while pregnant; three other newborns who died had kidney failure without confirmed low amniotic fluid when mothers took NSAIDs while pregnant. The low amniotic fluid levels started as early as 20 weeks of pregnancy. In 11 cases where low amniotic fluid levels were detected during pregnancy, the fluid volume returned to normal after the NSAID was stopped. The information from the cases was similar to what was found in the medical literature. In these publications, low amniotic fluid levels were detected with use of NSAIDs for varying amounts of time, ranging from 48 hours to multiple weeks. In most cases, the condition was reversible within 3 to 6 days after stopping the NSAID. In many reports, the condition was reversed when the NSAID was stopped, and it reappeared when the same NSAID was started again.