Zantac

Ranitidine injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• pain, burning, or itching in the area where the medication was injected

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• slow heartbeat
• hives
• itching
• rash
• difficulty breathing or swallowing
• swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
• hoarseness
• upset stomach
• extreme tiredness
• unusual bleeding or bruising
• lack of energy
• loss of appetite
• pain in the upper right part of the stomach
• yellowing of the skin or eyes
• flu-like symptoms

Ranitidine injection may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

GENERIC AVAILABLE: yes

Zantac is both an over-the-counter and a prescription medication used to treat conditions of the stomach, esophagus, and intestines. The over-the-counter (OTC) form is used to treat heartburn, acid indigestion, and sour or upset stomach. The prescription form is used to treat ulcers, GERD, erosive esophagitis, and other conditions.

Zantac belongs to a group of drugs called H2 blockers. It works by decreasing the amount of acid produced in the stomach.

This medication comes in regular tablet and syrup forms. Zantac is taken by mouth, up to 4 times a day. This medication is also available in an injectable form to be given directly into a vein (IV) or muscle (IM) by a healthcare professional. 

Zantac over-the-counter (OTC) comes in tablet form and can be taken up to twice a day. Do not chew tablets.

Common side effects include headache, diarrhea, and constipation. Zantac can cause dizziness and drowsiness. Do not drive or operate machinery until you know how Zantac affects you.

Serious side effects have been reported with Zantac. See “Drug Precautions” section.

Common side effects of Zantac include:

• headache
• constipation
• diarrhea
• nausea
• vomiting
• stomach pain
• dizziness
• fatigue

This is not a complete list of Zantac side effects. Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Histamine H2 receptor antagonist.1

• Inhibits daytime and nocturnal basal gastric acid secretion, stimulated gastric acid secretion.1 5 5 12

• Competitively inhibits histamine at parietal cell H2 receptors.1

• Importance of patients informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs.1

• Importance of women informing clinician if they are or plan to become pregnant or plan to breast-feed.1

• Importance of informing patients with phenylketonuria that oral effervescent tablets for solution contain aspartame.1

• When used for self-medication, importance of reading the product labeling and carefully reviewing the warning information provided by the manufacturer.287 288

• Importance of following dosage instructions, unless otherwise directed by a clinician, when ranitidine is administered for self-medication.287 288

• Importance of promptly informing clinician of persistent abdominal pain or difficulty swallowing.287 288

• Importance of informing patients of other important precautionary information. (See Cautions.)

Zantac is indicated in:

1. Short-term treatment of active duodenal ulcer. Most patients heal within 4 weeks. Trials available to date have not assessed the safety of ranitidine in uncomplicated duodenal ulcer for periods of more than 8 weeks. 2. Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers. No placebo-controlled comparative trials have been carried out for periods of longer than 1 year. 3. The treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome and systemic mastocytosis). 4. Short-term treatment of active, benign gastric ulcer. Most patients heal within 6 weeks and the usefulness of further treatment has not been demonstrated. Trials available to date have not assessed the safety of ranitidine in uncomplicated, benign gastric ulcer for periods of more than 6 weeks. 5. Maintenance therapy for gastric ulcer patients at reduced dosage after healing of acute ulcers. Placebo-controlled trials have been carried out for 1 year. 6. Treatment of GERD. Symptomatic relief commonly occurs within 24 hours after starting therapy with Zantac 150 mg twice daily. 7. Treatment of endoscopically diagnosed erosive esophagitis. Symptomatic relief of heartburn commonly occurs within 24 hours of therapy initiation with Zantac 150 mg 4 times daily. 8. Maintenance of healing of erosive esophagitis. Placebo-controlled trials have been carried out for 48 weeks.

Concomitant antacids should be given as needed for pain relief to patients with active duodenal ulcer; active, benign gastric ulcer; hypersecretory states; GERD; and erosive esophagitis.

Do not use Zantac if you are allergic to ranitidine.

Heartburn is often confused with the first symptoms of a heart attack. Seek emergency medical attention if you have chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, and a general ill feeling.

Ask a doctor or pharmacist if it is safe for you to take Zantac if you have:

• kidney disease;
• liver disease; or

• porphyria.

FDA pregnancy category B. Zantac is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Ranitidine passes into breast milk. Do not take Zantac without telling your doctor if you are breast-feeding a baby.

Using Zantac may increase your risk of developing pneumonia. Symptoms of pneumonia include chest pain, fever, feeling short of breath, and coughing up green or yellow mucus. Talk with your doctor about your specific risk of developing pneumonia.

The Zantac effervescent tablet may contain phenylalanine. Talk to your doctor before using this form of ranitidine if you have phenylketonuria (PKU).

Avoid drinking alcohol. It can increase the risk of damage to your stomach.