What is the maximum single dose of ibuprofen (Nonsteroidal Anti-Inflammatory Drug (NSAID)) for adults?

Maximum Single Dose of Ibuprofen for Adults

The maximum single dose of ibuprofen for adults is 800 mg, which can be administered every 6 hours, not to exceed 3200 mg per day. 1

FDA-Approved Dosing

The FDA label provides clear guidance on single-dose limits 1:

• Single dose for pain relief: 400 mg every 4-6 hours 1
• Maximum single dose: 800 mg (typically given every 6 hours for chronic conditions like rheumatoid arthritis and osteoarthritis) 1
• Absolute daily maximum: 3200 mg 1

Clinical Context for Single Dosing

For acute pain management, 400 mg is the optimal single dose because controlled trials demonstrate that doses greater than 400 mg provide no additional analgesic benefit 1. This finding is reinforced by recent emergency department research showing equivalent pain relief at 60 minutes whether patients received 400 mg, 600 mg, or 800 mg single doses 2.

Key Dosing Scenarios:

• Mild to moderate acute pain: 400 mg every 4-6 hours 1
• Dysmenorrhea: 400 mg every 4 hours as needed 1
• Chronic inflammatory conditions (rheumatoid arthritis, osteoarthritis): 400-800 mg three to four times daily 1
• Cancer pain: 400 mg every 4-6 hours (maximum 3200 mg/day) 3

Important Clinical Caveats

The 800 mg single dose is reserved for chronic inflammatory conditions, not acute pain. 1 While the FDA permits up to 800 mg as a single dose for conditions like rheumatoid arthritis, physicians should recognize that patients on 3200 mg daily dosing require sufficient clinical benefit to justify the increased risk 1.

Over-the-counter dosing limits are more conservative: Standard OTC dosing is 200-400 mg every 4-6 hours with a maximum daily dose of only 1200 mg 4. This lower threshold reflects the enhanced safety profile at OTC doses, which have gastrointestinal risks comparable to paracetamol 5, 6.

Safety Monitoring at Higher Doses:

• GI protection: Consider proton pump inhibitors for chronic use at higher doses 4
• High-risk patients (>60 years, history of peptic ulcer, significant alcohol use) require closer monitoring 3
• Renal monitoring: Stop if urea/creatinine doubles or hypertension develops 3
• Cardiovascular caution: Use carefully in patients with cardiovascular disease history 3

Practical Algorithm

1. For acute pain: Start with 400 mg single dose 1
2. If inadequate relief: Repeat 400 mg every 4-6 hours rather than increasing single dose 1
3. For chronic inflammatory disease: May use 400-800 mg per dose, up to four times daily 1
4. Never exceed: 800 mg single dose or 3200 mg daily total 1