Ranitidine was withdrawn from the market in the United States in April 2020.

Ranitidine belongs to a group of drugs called histamine-2 blockers. It works by reducing the amount of acid your stomach produces.

Ranitidine has been used to treat and prevent ulcers in the stomach and intestines. It also was used to treat conditions in which the stomach produces too much acid, such as Zollinger-Ellison syndrome..

Ranitidine was also used to treat gastroesophageal reflux disease (GERD) and other conditions in which acid backs up from the stomach into the esophagus, causing heartburn.

A cancer-causing impurity found in many ranitidine medications may increase to unacceptable levels over time and when ranitidine is stored at high temperatures. As a result, the FDA has asked all makers of ranitidine to withdraw this medicine from the market in the United States.

Ranitidine has been withdrawn from the market in the United States. Some of the contents of this leaflet are preserved for historical purposes only.

Using ranitidine 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 this medication 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.

Ranitidine 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 this medicine 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.

Ranitidine comes as a tablet, an effervescent tablet, effervescent granules, and a syrup to take by mouth. It is usually taken once a day at bedtime or two to four times a day. Over-the-counter ranitidine comes as a tablet to take by mouth. It is usually taken once or twice a day. To prevent symptoms, it is taken 30 to 60 minutes before eating or drinking foods that cause heartburn. Follow the directions on your prescription or the package label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take ranitidine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Dissolve ranitidine effervescent tablets and granules in a full glass (6 to 8 ounces [180 to 240 milliliters]) of water before drinking.

Do not take over-the-counter ranitidine for longer than 2 weeks unless your doctor tells you to. If symptoms of heartburn, acid indigestion, or sour stomach last longer than 2 weeks, stop taking ranitidine and call your doctor.

Because ranitidine has been withdrawn from the market in the U.S., some of the contents of this leaflet are intended for historical purposes only.

Take ranitidine exactly as directed on the label, or as prescribed by your doctor.

Measure liquid medicine carefully. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

It may take up to 8 weeks before your ulcer heals. Keep using your medications as directed and call your doctor if your symptoms do not improve after 6 weeks.

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.

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

If you have been taking prescription-strength ranitidine: Before you stop taking the medicine, ask your doctor about safer treatment options.

If you have been taking over-the-counter (OTC) ranitidine: Stop taking the medicine, and ask your doctor or pharmacist about other approved OTC stomach acid reducers.

Heartburn can mimic early symptoms of a heart attack. Get emergency medical help if you have chest pain that spreads to your jaw or shoulder and you feel anxious or light-headed.

Before using any OTC medicine to reduce stomach acid, ask a doctor or pharmacist if the medicine is safe for you if you have other medical conditions or allergies.

Ask a doctor before using any OTC stomach acid medicine if you are pregnant or breastfeeding.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

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.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unless your doctor tells you otherwise, continue your normal diet.

You should not stop taking prescription-strength ranitidine until you ask your doctor to prescribe a different medication. Talk with doctor as soon as possible about how best to treat your condition.

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

Get emergency medical help if you have signs of an allergic reaction to ranitidine: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using this medicine and call your doctor at once if you have:

• stomach pain, loss of appetite;

• dark urine, jaundice (yellowing of the skin or eyes);

• fever, chills, cough with mucus, chest pain, feeling short of breath;

• fast or slow heart rate;

• easy bruising or bleeding; or

• problems with your skin or hair.

Common ranitidine side effects may include:

• nausea, vomiting, stomach pain; or

• diarrhea, 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.

Many drugs can interact with ranitidine. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.

Keep all appointments with your doctor.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking ranitidine.

Do not let anyone else take your medicine. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.