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What is Zantac?

Zantac (ranitidine) belongs to a group of drugs called histamine-2 blockers. Zantac works by reducing the amount of acid your stomach produces.

Zantac is used to treat and prevent ulcers in the stomach and intestines. It also treats conditions in which the stomach produces too much acid, such as Zollinger-Ellison syndrome. Zantac also treats gastroesophageal reflux disease (GERD) and other conditions in which acid backs up from the stomach into the esophagus, causing heartburn.

Zantac may also be used for other purposes not listed in this medication guide.

Important information about Zantac

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.

Do not use Zantac if you are allergic to ranitidine.

Ask a doctor or pharmacist if it is safe for you to take this medicine if you have kidney disease, liver disease, or porphyria.

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.

Zantac granules and effervescent tablets must be dissolved in water before you take them. Your doctor may recommend an antacid to help relieve pain. Carefully follow your doctor's directions about the type of antacid to use, and when to use it. Avoid drinking alcohol. It can increase the risk of damage to your stomach. It may take up to 8 weeks of using Zantac before your ulcer heals. For best results, keep using the medication as directed. Talk with your doctor if your symptoms do not improve after 6 weeks of treatment.

Before using Zantac

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).

How should I take Zantac?

Take Zantac exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Your doctor may recommend an antacid to help relieve pain. Carefully follow your doctor's directions about the type of antacid to use, and when to use it.

Do not crush, chew, or break the Zantac effervescent tablet, and do not allow it to dissolve on your tongue. The 25-milligram effervescent tablet must be dissolved in at least 1 teaspoon of water before swallowing. The150-milligram effervescent tablet should be dissolved in 6 to 8 ounces of water.

Allow the Zantac effervescent tablet to dissolve completely in the water, and then drink the entire mixture. If you are giving this medicine to a child, you may draw the liquid mixture into a medicine dropper and empty the dropper into the child's mouth.

Zantac granules should be mixed with 6 to 8 ounces of water before drinking.

Measure Zantac liquid with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

It may take up to 8 weeks before your ulcer heals. Keep using the medication as directed and tell your doctor if your symptoms do not improve after 6 weeks of treatment.

This medication can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using Zantac.

Store Zantac at room temperature away from moisture, heat, and light.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include lack of coordination, feeling light-headed, or fainting.

What should I avoid while taking Zantac?

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

Zantac side effects

Stop using Zantac and get emergency medical help if you have any of these signs of an allergic reaction to Zantac: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop taking Zantac and call your doctor at once if you have a serious side effect such as:

  • chest pain, fever, feeling short of breath, coughing up green or yellow mucus;

  • easy bruising or bleeding, unusual weakness;

  • fast or slow heart rate;

  • problems with your vision;

  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash; or

  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious Zantac side effects may include:

  • headache (may be severe);

  • drowsiness, dizziness;

  • sleep problems (insomnia);

  • decreased sex drive, impotence, or difficulty having an orgasm; or

  • swollen or tender breasts (in men);

  • nausea, vomiting, stomach pain; or

  • diarrhea or constipation.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Zantac?

Before taking Zantac, tell your doctor if you are taking triazolam (Halcion). You may not be able to use Zantac, or you may need dosage adjustments or special tests during treatment.

There may be other drugs that can interact with Zantac. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

For the Consumer

Applies to ranitidine: oral solution, oral tablets and tablets for, oral tablets effervescent for solution, parenteral injection, parenteral injection for iv infusion only

Side effects include:

Oral or parenteral therapy: Headache, sometimes severe.

IM therapy: Transient pain at injection site.

IV therapy: Transient local burning or itching.

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Applies to ranitidine: compounding powder, injectable solution, intravenous solution, oral capsule, oral granule effervescent, oral syrup, oral tablet, oral tablet effervescent

General

Ranitidine (the active ingredient contained in Zantac) is generally well tolerated.

Gastrointestinal

Gastrointestinal side effects have included constipation, nausea/vomiting, diarrhea, abdominal pain, and rare reports of pancreatitis. Rebound acid hypersecretion has been reported after discontinuation of therapy. A case report of coinfection with Giardia lamblia and Clostridium difficile has been attributed to the achlorhydria induced by ranitidine (the active ingredient contained in Zantac) predisposing the patient to the enteric infection.

Hepatic

Hepatic side effects have included transient and minor increases in serum transaminases, which may be important in patients with liver disease. There are rare reports of ranitidine-induced hepatitis with or without jaundice, one case of subfulminant hepatitis with a fatal outcome, and very rare cases of acute interstitial nephritis.

Overall, serious hepatotoxicity due to ranitidine is rare. Hepatocellular, hepatocanalicular, and mixed-type injury have been reported. In most cases, hepatotoxicity has been associated with fever, chills, nausea, and occasionally rash and eosinophilia, with onset of symptoms early in the course of therapy. Such symptomatology is suggestive of a hypersensitivity etiology. The majority of cases resolve following discontinuation of ranitidine therapy although, at least two fatalities have been reported.

In a study with healthy volunteers , SGPT values were increased to at least twice the pretreatment levels in 6 of 12 subjects receiving 100 mg intravenously four times daily for 7 days, and in 4 of 24 subjects receiving 50 mg intravenously four times daily for 5 days.

Hypersensitivity

Hypersensitivity side effects have included rash, urticaria, bronchospasm, fever, eosinophilia, angioneurotic edema, acute eosinophilic pneumonia and anaphylaxis. Vasculitis associated with immune complexes has also been reported.

Hematologic

Hematologic side effects have included leukopenia, granulocytopenia, and thrombocytopenia in a few patients. These were usually reversible. Rare cases of agranulocytosis, pancytopenia, sometimes with marrow hypoplasia, aplastic anemia, and acquired immune hemolytic anemia have been reported.

Serious hematologic abnormalities are rare. Patients with renal dysfunction or those who are critically ill may be at increased risk. While the mechanism of bone marrow toxicity is unknown, ranitidine concentration-dependent inhibition of hematopoietic progenitor cell activity and hypersensitivity have both been proposed. Hematologic abnormalities typically resolve upon discontinuation of ranitidine therapy.

Cases of ranitidine-induced thrombocytopenia are typically immune-mediated.

Endocrine

Endocrine side effects have been reported rarely. These have included gynecomastia, impotence, and loss of libido in male patients, although, the incidence was similar to that in the general population. Hyperprolactinemia, amenorrhea, reductions in circulating levothyroxine and hypergastrinemia have also been reported.

Ranitidine does not possess antiandrogenic properties nor has it been associated with significant changes in pituitary hormone concentrations under study conditions. However, increases in prolactin serum concentrations following administration of high doses as well as decreases in levothyroxine serum concentrations during short-term therapy have been reported. Thyroid hormone levels are not affected during long-term therapy.

Nervous system

The mechanism by which ranitidine (the active ingredient contained in Zantac) induces mental status changes is not well established but appears to involve increased serum concentrations of ranitidine. Renal dysfunction, advanced age, and critical illness appear to be associated with an increased risk of central nervous system toxicity. Onset of symptoms is typically within the first few weeks of therapy, but may be delayed. Following discontinuation of ranitidine, mental status usually normalizes over several days.

Nervous system side effects have been reported rarely. These have included headache (sometimes severe), somnolence, dizziness, malaise, and vertigo. Reversible mental confusion, agitation, depression, and hallucinations have been reported, predominantly in severely ill elderly patients. Hostility, mania, mental status changes, dystonia, reversible involuntary motor disturbances have also been reported.

Renal

Renal side effects have included mild elevations in serum creatinine. Rare cases of interstitial nephritis and Fanconi's syndrome have been reported.

Dermatologic

Dermatologic side effects have included alopecia, rash, pruritus, contact dermatitis, erythema multiforme, cutaneous vasculitis, and toxic epidermal necrolysis.

Two cases of toxic epidermal necrolysis have been reported in patients with underlying idiopathic thrombocytopenia purpura. A 72-year-old male also experienced a photosensitivity reaction that resolved after ranitidine was discontinued.

Ocular

Ocular side effects have included blurred vision and increased intraocular pressure in a patient with a history of glaucoma.

Other

Other reported side effects have included tiredness and one case of aseptic meningitis.

Cardiovascular

Cardiovascular side effects have rarely included tachycardia, bradycardia, atrioventricular block, and premature ventricular beats. Several cases of bradycardia following intravenous administration of ranitidine (the active ingredient contained in Zantac) have been reported. Ranitidine-induced bradycardia may be due to a rise in the serum histamine concentration or due to a direct effect of ranitidine on cardiac H2 receptors.

Musculoskeletal

Musculoskeletal side effects have included arthralgias and myalgias.

Respiratory

Respiratory side effects have included an increased risk of developing pneumonia in patients taking H2 receptor antagonists versus those who had stopped treatment. However, a causal relationship has not been established.