Ranitidine (Discontinued)

Ranitidine was a prescription medication used to treat gastroesophageal reflux disease (GERD). 

• Ranitidine was available under the following different brand names: Zantac, Zantac 150 Maximum Strength, Zantac 75.

Adult and pediatric dosage

Injection solution

• 25mg/mL

Syrup

• 15mg/mL

Tablet

• 75mg
• 150mg
• 300mg

Capsule

• 150mg
• 300mg

Gastroesophageal Reflux Disease

Adult dosage

• 150 mg orally every 12 hours or 50 mg IM/IV every 6-8 hours

Pediatric dosage

• Children 1 month-16 years: 5-10 mg/kg/day orally divided every 12 hours; not to exceed 300 mg/day

Gastric Ulcer, Benign

Adult dosage

• 150 mg orally every 12 hours or 300 mg orally at bedtime
• Maintenance of healing: 150 mg orally at bedtime

Pediatric dosage

• Treatment: 4-8 mg/kg orally every 12 hours; not to exceed 300 mg/day
• Maintenance: 2-4 mg/kg orally once daily; not to exceed 150 mg/day
• Parenteral: 2-4 mg/kg/day IV divided every 6-8 hours; not to exceed 50 mg/dose or 200 mg/day

Erosive Esophagitis

Adult dosage

• 150 mg orally every 6 hours or 50 mg IM/IV every 6-8 hours intermittent bolus or infusion; alternatively, 6.25 mg/hour IV by continuous infusion 
• Maintenance of healing: 150 mg orally every 12 hours

Pediatric dosage

• Children 1 month-16 years: 5-10 mg/kg/day orally divided every 12 hours; not to exceed 300 mg/day

Hypersecretory Conditions

Adult dosage

• 150 mg orally every 12 hours; up to 6 g/day used
• Parenteral: 50 mg (2mL) IM or intermittent IV bolus or infusion every 6-8 hours; not to exceed 400 mg/day; alternatively, 6.25 mg/hour continuous infusion 

Dosage Considerations – Should be Given as Follows: 

• See "Dosages."

Common side effects of Ranitidine include:

• nausea, 
• vomiting, 
• stomach pain, 
• diarrhea, and
• constipation 

Serious side effects of Ranitidine include:

• hives, 
• difficulty breathing, 
• swelling of the face, lips, tongue, or throat, 
• stomach pain, 
• loss of appetite, 
• dark urine, 
• yellowing of the skin or eyes (jaundice), 
• fever, 
• chills, 
• cough with mucus, 
• chest pain, 
• shortness of breath, 
• fast or slow heart rate, 
• easy bruising, 
• unusual bleeding, and
• problems with the skin or hair

Rare side effects of Ranitidine include:

• pancreatitis
• deficiency of platelets in the blood
• reduction of all blood cells
• lowered white blood cells
• acquired immune hemolytic anemia
• joint pain
• muscle pain

This is not a complete list of side effects and other serious side effects or health problems may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

• Ranitidine has severe interactions with no other drugs.
• Ranitidine has serious interactions with the following drugs:
  • infigratinib
  • lonafarnib
  • sotorasib
  • trilaciclib
• Ranitidine has moderate interactions with the following drugs:
  • atogepant
  • finerenone
  • isavuconazonium sulfate
• Ranitidine has minor interactions with no other drugs. 

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this drug, tell your doctor or pharmacist of all the drugs you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

Contraindications

• Hypersensitivity to ranitidine or components of the formulation.

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Ranitidine?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Ranitidine?”

Cautions

• If gastroesophageal reflux disease does not respond adequately in 6-8 weeks, do not increase dosage; prescribe proton pump inhibitor instead
• Prolonged treatment may lead to B12 malabsorption and subsequent vitamin B12 deficiency; degree of deficiency is dose-related and association stronger in females and younger in age (younger than 30 years)
• Use caution in renal impairment; adjust dosage
• Use caution in hepatic impairment
• Elevation of ALT levels reported with higher doses (more than or equal to 100 mg) or prolonged IV therapy (5 or more days); monitor for ALT levels for the remainder of treatment
• Avoid in patients with acute porphyria; may precipitate attack
• Symptom relieve does not rule out presence of gastric malignancy
• Reversible confusional state reported with use (linked to age  above 50 years and renal or hepatic impairment); clears within 3-4 days after discontinuation
• If patient taking a prescription drug, the patient should ask a doctor or a pharmacist whether acid reducers can be taken concomitantly with it
• Patients with kidney disease should ask doctor before use

Pregnancy and Lactation

• Use may be acceptable during pregnancy.  
• Lactation: Drug crosses into breast milk; discontinue drug, use caution.