When ibuprofen was introduced in the United States in 1974, the recommended dose was 1200–3200 mg/day. This amount is three times the current recommended dose. The use became widespread and it was confirmed by the FDA as one of the safest of the nonsteroidal anti-inflammatory drugs (NSAIDs); However, concerns about side effects to the liver and stomach had been mounting for some time.
Ibuprofen’s safety record remained good with problems only being related to overdosing. The product was “Fast Tracked” from prescription to over the counter (OTC) status by the FDA.
It became available in the UK in 1983 under the brand name “Nurofen” and in the United States in 1984 under the brand name “Advil“. Anyone could buy it without a prescription for the treatment of headaches, dental pain, migraine and menstrual pain.
By 1985, an estimated 100 million people had been treated with ibuprofen in more than 120 countries.
