Studies indicate that people who take proton pump inhibitor medications (such as Nexium) may be at an increased risk for broken bones. The risk appears to be highest for people who take such medications at high doses or for long periods (over a year). You and your healthcare provider should take this into account when deciding if the benefits of this medication outweigh the risks for your particular situation.

The use of proton pump inhibitors (including this medication) may increase the risk of a potentially serious condition known as Clostridium difficile-associated diarrhea (CDAD). If you develop diarrhea that does not seem to improve (especially if it is watery and accompanied by a fever and abdominal pain), seek immediate medical attention.

The prominent consumer watchdog group Public Citizen has filed a petition with the FDA, indicating that a new black box warning for Nexium, Prilosec and other proton pump inhibitor drugs is necessary to warn consumers and the medical community about the risk of long-term dependence and other dangerous side effects.

According to the petition (PDF) filed with the FDA on Tuesday, Public Citizen indicates that the strongest possible warning label is necessary for the widely used acid reflux drugs, which were prescribed more than 119 million times in 2009 and generated sales in the United States of $13.6 billion.

An estimated one out of every 20 people in the developed world are currently taking a proton pump inhibitor (PPI) to reduce the production of stomach acid in an attempt to alleviate symptoms of gastroesophageal reflux disease (GERD), ulcers and other stomach ailments. In addition to Nexium and Prilosec, other drugs in the same class included Prevacid, Zegerid, Protonix, Dexilant, Aciphex, Vimovo and a number of generic equivalents.

Ranitidine is used to treat ulcers of the stomach and intestines and prevent them from returning after treatment. This medication is also used to treat and prevent certain stomach and throat (esophagus) problems caused by too much stomach acid (e.g., Zollinger-Ellison syndrome, erosive esophagitis) or a backward flow of stomach acid into the esophagus (gastroesophageal reflux disease-GERD).

Ranitidine is known as an H2 histamine blocker. It works by reducing the amount of acid in your stomach. This helps heal and prevent ulcers and improves symptoms such as heartburn and stomach pain.

This medication is also available without a prescription. It is used to prevent and treat heartburn and other symptoms caused by too much acid in the stomach (acid indigestion). If you are taking this medication for self-treatment, it is important to read the manufacturer's package instructions carefully so you know when to consult your doctor or pharmacist.

How to use Acid Control (ranitidine)

Take this medication by mouth with or without food, usually once or twice daily or as directed by your doctor. It may be prescribed 4 times a day for some conditions. If you are taking this medication once daily, it is usually taken after the evening meal or before bedtime.

The dosage and length of treatment are based on your medical condition and response to therapy. In children, dosage may also be based on body weight. Follow your doctor's instructions carefully. You may take other medications (e.g., antacids) for your condition as recommended by your doctor.

Take this medication regularly in order to get the most benefit from it. To help you remember, take it at the same time(s) each day. Do not increase your dose or take it more often than prescribed. Do not stop taking this without your doctor's approval because this may delay healing of the ulcer.

If you are using nonprescription ranitidine for self-treatment of acid indigestion or heartburn, take 1 tablet by mouth with a glass of water as needed. To prevent heartburn, take 1 tablet by mouth with a glass of water 30-60 minutes before eating food or drinking beverages that cause heartburn. Do not take more than 2 tablets in 24 hours unless directed by your doctor. Do not take for more than 14 days in a row without talking with your doctor.

Inform your doctor if your condition does not improve or if it worsens.

Headache, dizziness, constipation or diarrhea may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

If your doctor has directed you to use this medication, remember that he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: blurred vision, mental/mood changes (e.g., agitation, confusion, depression, hallucinations).

Tell your doctor immediately if any of these rare but very serious side effects occur: easy bleeding/bruising, enlarged breasts, severe tiredness, fast/slow/irregular heartbeat, signs of infection (e.g., fever, persistent sore throat, cough), severe stomach/abdominal pain, dark urine, yellowing skin/eyes.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada.

Before taking ranitidine, tell your doctor or pharmacist if you are allergic to it; or to other H2 histamine blockers (e.g., cimetidine, famotidine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: a certain blood disorder (porphyria).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: immune system problems, kidney problems, liver problems, lung diseases (e.g., asthma, chronic obstructive pulmonary disease-COPD), other stomach problems (e.g., tumors).

Some symptoms may actually be signs of a more serious condition. Get medical help right away if you have: heartburn with lightheadedness/sweating/dizziness, chest/jaw/arm/shoulder pain (especially with shortness of breath, unusual sweating), unexplained weight loss.

In addition, before you self-treat with this medication, get medical help right away if you have any of these signs of a serious condition: trouble/pain swallowing food, bloody vomit, vomit that looks like coffee grounds, bloody/black stools, heartburn for over 3 months, frequent chest pain, frequent wheezing (especially with heartburn), nausea/vomiting, stomach pain.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Do not use to treat children younger than 12 unless directed by the doctor.

Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, elderly people may be at greater risk for side effects while using this drug. Caution is advised when using this drug in the elderly because they may be more sensitive to its effects, especially confusion and dizziness.

Ranitidine should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

Ranitidine passes into breast milk. Consult your doctor before breast-feeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: procainamide, propantheline.

This medication decreases the amount of acid in your stomach. This can change the amount of medication absorbed from your stomach which may affect how these medications work. Examples of affected drugs include atazanavir, delavirdine, dasatinib, gefitinib, pazopanib, raltegravir, triazolam among others. Azole antifungals such as ketoconazole may also be affected.

Check the labels on all your medicines because they may contain aspirin or aspirin-like NSAIDs (e.g., ibuprofen, naproxen) that can cause stomach irritation/ulcers. Ask your pharmacist about the safe use of those products. Low-dose aspirin, as prescribed by your doctor for specific medical reasons such as heart attack or stroke prevention (usually at dosages of 81-325 milligrams per day), should be continued. Consult your doctor or pharmacist for more details.

This medication and similar H2 histamine blockers (e.g., cimetidine, famotidine) are available both over-the-counter and by prescription. Do not take them at the same time.

This medication may interfere with certain laboratory tests (e.g., urine protein), possibly causing false test results. Make sure laboratory personnel and your doctors know you use this drug.

If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include difficulty walking, severe dizziness/fainting.

Notes

Do not share this medication with others.

Lifestyle changes such as stress reduction programs, stopping smoking, limiting alcohol, and diet changes (e.g., avoiding caffeine, certain spices) may increase the effectiveness of this medication. Talk to your doctor or pharmacist about lifestyle changes that might benefit you.

Laboratory and/or medical tests (e.g., endoscopy, kidney function tests) may be performed to monitor your progress or check for side effects. Consult your doctor for more details.

Missed Dose

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Storage

Store the US product in a tightly closed container at room temperature between 59-86 degrees F (15-30 degrees C) away from moisture and light. Store the nonprescription medication at room temperature between 68-86 degrees F (20-30 degrees C).

Store the Canadian product in a tightly closed container between 35.6 and 86 degrees F (2 and 30 degrees C) away from moisture and light.

Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2014. Copyright(c) 2014 First Databank, Inc.