Gastroesophageal reflux disease, or GERD, is an extremely common digestive condition experienced by an estimated 15 to 30 percent of Americans.
People with GERD experience heartburn or indigestion at least twice per week over a prolonged period of time.
There are many factors that have contributed to the rising prevalence of GERD in the United States, including the obesity epidemic, as people who are overweight or obese are more likely to suffer from the condition.
Over the counter (OTC) medications and medications like prescription ranitidine drugs have offered relief of mild to moderate occasional symptoms of GERD for many people, particularly when used in conjunction with diet and lifestyle changes.
GERD usually does not resolve without substantial lifestyle changes and dietary changes no matter what type of medication is taken, but many people need medication to control their symptoms.
What is ranitidine?
Ranitidine hydrochloride is a medication more commonly known under its brand name, ranitidine, that belongs to a class of medications called Histamine-2 receptor blockers, or H-2 blockers, including famotidine, cimetidine, and nizatidine.
H-2 blockers, also called H02 antagonists, were the first drugs used to treat ulcers and remained the most popular medication for the treatment of GERD and ulcers through the 1980s.
Ranitidine and all ranitidine products were recalled by the U.S. Food and Drug Administration (FDA) in April 2020 due to unacceptable levels of NDMA, a nitrosamine impurity called N-nitrosodimethylamine in some ranitidine products, as of August 2020, ranitidine tablets and other products manufactured with ranitidine are no longer available for purchase as treatment options.
Prior to the recall, ranitidine was available both over the counter at a lower strength and in prescription drug form at a higher strength.
What conditions is ranitidine used to treat?
Ranitidine is used to treat a number of digestive conditions that result from the overproduction of stomach acid, including GERD, Zollinger-Ellison Syndrome, stomach ulcers, and esophagitis.
Some of these conditions are described briefly below.
Gastroesophageal Reflux Disease (GERD)
Gastroesophageal reflux disease, commonly referred to as GERD or heartburn, is a chronic condition that is characterized by a backward flow of stomach acid and digestive enzymes from the stomach into the esophagus.
Heartburn symptoms are experienced by many people on occasion, but the condition is diagnosed as gastroesophageal reflux disease when symptoms are experienced multiple times per week over a long period of time.
GERD is most commonly caused by a dysfunctional esophageal sphincter, which is a muscular ring that is supposed to seal the esophagus off from the stomach to prevent food and acid from coming back up the esophagus.
In people with GERD, the esophageal sphincter often does not function properly and does not seal tightly enough.
A dysfunctional esophageal sphincter stays relaxed between swallows, allowing food and digestive juices to enter the esophagus.
Over time, GERD can cause serious damage to the esophagus, including inflammation, development of open sores, narrowing, or development of a condition called Barrett’s esophagus, which is associated with an increased risk of esophageal cancer.
People with GERD often experience some or all of the following symptoms:
- Sharp or burning pain behind the breast bone
- Tightness in the chest or upper abdomen
- A repeated sour or bitter taste in the mouth
- Sore throat
- Difficulty swallowing
- Coughing, wheezing or needing to clear your throat
Zollinger-Ellison syndrome is rare, but it is a serious medical condition that can cause great discomfort. People with Zollinger-Ellison syndrome suffer from the formation of tumors in the pancreas or upper small intestines.
Tumors caused by Zollinger-Ellison syndrome encourage the overproduction of acid in the stomach by secreting large amounts of a hormone called gastrin.
Over time, the extra acid begins to cause peptic ulcers, diarrhea, and other symptoms. Most people are diagnosed with Zollinger-Ellison syndrome between the ages of 20 and 50, but a diagnosis can occur at any time in life.
Symptoms associated with Zollinger-Ellison syndrome include:
- Nausea and vomiting
- Abdominal pain
- Burning, aching, or discomfort in the upper abdomen
- Decreased appetite
- Acid reflux and heartburn
- Bleeding in the digestive tract
How does ranitidine work?
The H-2 blockers class of drugs like ranitidine work by acting on histamine receptors in the body. In addition to producing allergic reactions to allergens in people with allergies, histamine also directs the stomach lining to produce hydrochloric acid.
H-2 blockers like ranitidine prevent histamine from binding and directing the production of hydrochloric acid by binding to the H-2 receptors in the stomach.
Because the production of hydrochloric acid is lowered, peptic ulcers have time to heal, and heartburn and GERD are less likely to occur.
What dose of ranitidine should I take?
Prior to the recall, ranitidine was available in oral tablets with strengths of 75 mg, 150 mg, and 300 mg.
When taken to treat ulcers, the standard dose of ranitidine is 150 mg taken twice daily, but some people are able to find relief from their symptoms by taking one 300 mg dose after dinner or at bedtime.
Patients taking ranitidine to manage Zollinger-Ellison syndrome and GERD are generally advised to take 150 mg twice daily.
What is the cost of ranitidine?
Ranitidine is no longer available for sale either over the counter or by prescription since its recall by the FDA in April 2020.
Prior to the recall, the medication was available both over the counter and by prescription and was considered highly affordable, with a bottle of the generic medication selling for less than ten dollars.
What are the benefits of taking ranitidine?
Ranitidine is a very effective medication for patients with mild to moderate symptoms of heartburn that occur no more than twice per week and do not need to take long-term medication for the management of their condition.
Ranitidine works best when taken on an empty stomach, so it is convenient for most people to take them first thing in the morning.
Ranitidine is more effective at lowering acidity and relieving symptoms associated with heartburn compared to medications like Pepcid, and it also works faster.
Ranitidine is well-suited to short-term use because H-2 blockers are effective at treating symptoms for two to six weeks before the body begins to adjust to the medication and work around it.
For most people with GERD, the low cost and easy accessibility of ranitidine, combined with its effectiveness for short periods, is sufficient for control of their symptoms.
Are there any side effects associated with ranitidine?
- Difficulty having an orgasm
- Swollen or tender breasts (in men)
- Decreased sex drive
- Headache (sometimes severe)
- Muscle pain
- Stomach pain
Are there any drug interactions associated with ranitidine?
There are relatively few drug interactions associated with ranitidine, but patients should always mention any medications and supplements they take to their healthcare provider prior to taking a new medication, as some drug interactions may occur, and it’s important to be thorough with drug information.
Drugs that may interact with ranitidine and cause moderate to severe adverse effects include:
- Blood thinners, such as warfarin
Why was ranitidine recalled by the U.S. Food and Drug Administration?
Ranitidine and all associated products, including brand name Zantac, were recalled by the U.S. Food and Drug Administration (FDA) in April 2020.
The products were recalled due to the presence of a nitrosamine impurity called N-nitrosodimethylamine (NDMA) that was found in some ranitidine products.
Under normal storage conditions, NDMA levels were found to increase over time in ranitidine products, and when the products were stored at high temperatures, the NDMA levels increased at an even faster rate, becoming a probable human carcinogen.
When people are exposed to nitrosamine impurities, like NDMA, at a level above what is recommended for an extended period of time, they may be at an increased risk of cancer.
Because some patients use ranitidine regularly for the management of digestive conditions and may store the medication on their shelves for a long period of time, the medication was recalled.
It should be noted that NDMA is considered safe when consumed at or below the recommended daily intake level, in which a patient could ingest NDMA everyday for 70 years without an increased risk of cancer.
However, NDMA levels were found to be dangerously high in some ranitidine products, which prompted a total recall of all ranitidine products by the FDA.
What alternatives to ranitidine are available?
Although ranitidine is no longer available for sale, several alternatives on the market are still available and are considered safe.
Alternatives to ranitidine include other H2 blockers like Pepcid and Tagamet, antacids like Tums, Mylanta, and Rolaids, and proton pump inhibitors (PPIs) like Nexium (esomeprazole), Prilosec (omeprazole), and Prevacid (lansoprazole).
It should be noted that antacids are intended to provide fast-acting relief for indigestion and heartburn on a temporary basis but may only offer relief for 30 to 60 minutes at a time.
PPIs are more appropriate for persistent cases of GERD, although long term use of PPIs is not without risks. Patients should speak to their healthcare professional about the right ranitidine alternative for their specific situation.
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