Nonsteroidal anti-inflammatory drugs (NSAIDs) are available by prescription and over-the-counter (OTC). They are used to relieve fever and pain, such as those associated with headaches, colds, flu, and arthritis. Examples of prescription NSAIDs include ibuprofen, naproxen, diclofenac, and celecoxib. Ibuprofen and naproxen are also available OTC at lower strengths.
Information on NSAIDs
- Section 505(o)(4) FDAAA Safety Labeling Change Notification for “Use of NSAIDs during pregnancy and potential serious risks of fetal renal dysfunction, oligohydramnios, and neonatal renal impairment”. The SLC notification letter was issued to NSAIDs approved under section 505(b) and certain NSAIDs approved under 505(j), (12/09/2020). NEW
- FDA Drug Safety Communication: FDA recommends avoiding use of NSAIDs in pregnancy at 20 weeks or later because they can result in low amniotic fluid
- The Benefits and Risks of Pain Relievers: Q&A on NSAIDs with Sharon Hertz, M.D.
- FDA Strengthens Warning of Heart Attack and Stroke Risk for Non-Steroidal Anti-Inflammatory Drugs
- FDA Drug Safety Communication: FDA strengthens warning that non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) can cause heart attacks or strokes
- FDA Drug Safety Communication: FDA has reviewed possible risks of pain medicine use during pregnancy
- COX-2 Selective (includes Bextra, Celebrex, and Vioxx) and Non-Selective Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)