Zantac is back

By Assoc Prof Geraldine Moses Apr 25

Two forms of the anti-reflux drug ranitidine (‘Zantac’) are back on the Australian market, five years after being withdrawn due to safety concerns.

Ranitidine (‘Zantac’) was previously available as 150mg and 300mg tablets since the 1980’s as Australia’s favourite anti-reflux medicine.  It was the first anti-reflux medicine that could be taken as a simple tablet and that worked by reducing stomach acid production. As its effect on blocking stomach acid pumps was short lived (unlike modern proton pump inhibitors that permanently block stomach acid pumps) it was very safe and eventually became available for general sale without prescription.

However, ranitidine was removed from the Australian market in September 2019 due to concerns over N-Nitrosodimethylamine (NDMA) impurities, classified as probable carcinogens, which were discovered in the manufacturing process.

 In addition, the FDA determined that the NDMA impurity in some ranitidine products increased over time and may result in unacceptable levels of exposure if stored at higher than room temperatures. All brands of ranitidine were withdrawn worldwide for this reason by January 2020. 

In Australia, the medication’s sponsor, Aspen Pharmacare Australia, has been working with the Therapeutic Goods Administration to ensure ranitidine manufacture met the requirements for nitrosamine content for inclusion in the Australian Register of Therapeutic Goods.  The company said it has also worked with the TGA to show the drug was stable throughout its shelf life and that nitrosamines are controlled within internationally established acceptable intake limits applied to the maximum daily dose.   

Ranitidine has been available again in Australian pharmacies and grocery outlets since 1st October 2024, but it seems not many people are aware that their old favourite anti-reflux medicine is back!

Ranitidine is a histamine-2 receptor antagonist (H2RA) over-the-counter medicine for the treatment of gastro-oesophageal reflux symptoms.  The 150mg tablets are for 12-hour relief from heartburn and acid indigestion, while the double strength tablets are for 24-hour relief of symptoms of gastro-oesophageal reflux.