What FDA-approved Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) are used for the treatment of dysmenorrhea?

FDA-Approved NSAIDs for Dysmenorrhea Treatment

Ibuprofen and naproxen are the FDA-approved NSAIDs specifically indicated for the treatment of dysmenorrhea, with ibuprofen having the strongest evidence for first-line use. 1, 2

FDA-Approved NSAIDs for Dysmenorrhea

First-Line Options

• Ibuprofen: FDA-approved specifically for dysmenorrhea at a dose of 400 mg every 4-6 hours as needed for pain relief 1
• Naproxen/Naproxen sodium: FDA-approved for dysmenorrhea treatment 2

Dosing Recommendations

Ibuprofen

• Recommended dose: 400 mg every 4-6 hours as necessary for pain relief
• Maximum daily dose: 3200 mg
• Administration: Take with food or milk if GI complaints occur

Naproxen

• OTC dose: 200-220 mg (naproxen sodium)
• Prescription dose: Can be higher based on pain severity
• Timing: Most effective when started at earliest onset of menstrual pain

Efficacy Comparison

Research shows that naproxen 400 mg provides greater pain relief than acetaminophen and placebo within 30 minutes of administration. Both naproxen 400 mg and 200 mg demonstrate superior pain relief compared to acetaminophen and ibuprofen at 6 hours after administration 3. However, ibuprofen has a favorable safety profile at the recommended dosage for dysmenorrhea and is often preferred as first-line therapy due to its rapid onset of action.

Important Precautions

Contraindications

• Third trimester of pregnancy: NSAIDs are strongly contraindicated due to risk of premature closure of the ductus arteriosus 4
• History of NSAID-induced asthma or allergic reactions
• Active peptic ulcer disease
• Severe renal impairment

Cautions

• Fertility concerns: Consider discontinuing NSAIDs pre-conception if the patient is having difficulty conceiving due to possible NSAID-induced unruptured follicle syndrome 4
• Cardiovascular risk: Use with caution in patients with cardiovascular disease; naproxen and ibuprofen are preferred in these patients 4
• Renal function: Monitor serum creatinine in patients at risk of renal failure 4
• Concomitant anticoagulant use: Increases risk of bleeding 3-6 times 4

Clinical Pearls

• Use the lowest effective dose for the shortest duration to minimize adverse effects
• Nonselective NSAIDs are recommended over COX-2 specific inhibitors for dysmenorrhea due to limited data on the latter 4
• Starting NSAID therapy at the earliest onset of menstrual pain provides better symptom control 5
• For patients with recurrent dysmenorrhea, consider starting treatment 1-2 days before anticipated menstruation for preventive effect

Monitoring

• Monitor for GI symptoms, which occur in 10-20% of patients taking NSAIDs
• Be vigilant for signs of GI bleeding, especially in high-risk patients
• Assess for changes in blood pressure, particularly in patients with hypertension

The evidence strongly supports the use of NSAIDs as first-line therapy for dysmenorrhea, with ibuprofen and naproxen having specific FDA approval for this indication. Their effectiveness is attributed to their ability to block prostaglandin synthesis, which is implicated in the pathophysiology of dysmenorrhea 6.