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.

How to use ranitidine

Dissolve 1 tablet in at least 1 teaspoon (5 milliliters) of water. After the tablet is completely dissolved, give the solution by mouth with or without food, usually once or twice daily or as directed by your doctor. When giving the solution to an infant, it is best to use a medicine dropper or oral syringe (available from your pharmacist). If this medication is being used once daily, it is usually taken after the evening meal or before bedtime.

The dosage and length of treatment are based on medical condition and response to therapy. In children, dosage may also be based on body weight. Follow the doctor's instructions carefully. Other medications (e.g., antacids) may be taken if needed as recommended by the doctor.

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

Tell the doctor if the condition does not improve or if it worsens.

Drowsiness, dizziness, headache, abdominal discomfort, nausea, vomiting, diarrhea and constipation may occur. If any of these effects persist or worsen, notify the doctor or pharmacist promptly.

Remember that the doctor has prescribed this medication because he or she has judged that the benefit is greater than the risk of side effects. Many people using this medication do not have serious side effects.

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

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

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 the 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 using ranitidine, tell the doctor or pharmacist if your child is allergic to it; or to other H2 histamine blockers (e.g., cimetidine, famotidine); or if your child has 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 your child has certain medical conditions. Before using this medication, tell the doctor or pharmacist if your child has: a certain blood disorder (porphyria).

Before using this medication, tell the doctor or pharmacist your child's medical history, especially of: immune system problems, kidney problems, liver problems, lung problems (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 your child has: heartburn with lightheadedness/sweating/dizziness, chest/jaw/arm/shoulder pain (especially with shortness of breath, unusual sweating), unexplained weight loss.

This medicine may contain aspartame. If your child has phenylketonuria (PKU) or any other condition that requires intake of aspartame (or phenylalanine) to be restricted, consult the doctor or pharmacist regarding the safe use of this medicine.

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.

This medication 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 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 the 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 all the doctors know your child is using this drug.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

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 or your child.

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

Missed Dose

If a dose is missed, give it as soon as remembered. If it is near the time of the next dose, skip the missed dose and resume the usual dosing schedule. Do not double the dose to catch up.

Storage

Store in the original foil packages between 36-86 degrees F ( 2-30 degrees C) away from moisture and light. Do not open until ready to use. Discard any medication in damaged/opened packages. 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 June 2014. Copyright(c) 2014 First Databank, Inc.