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Ranitidine Side Effects

Medically reviewed by Drugs.com. Last updated on April 2, 2020.

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

Warning

Special Alerts:

[Posted 04/01/2020]

ISSUE: The FDA announced it is requesting manufacturers to withdraw all prescription and over-the-counter (OTC) ranitidine drugs from the market immediately.

This is the latest step in an ongoing investigation of a contaminant known as N-Nitrosodimethylamine (NDMA) in ranitidine medications (commonly known by the brand name Zantac). NDMA is a probable human carcinogen (a substance that could cause cancer). FDA has determined that the impurity in some ranitidine products increases over time and when stored at higher than room temperatures may result in consumer exposure to unacceptable levels of this impurity. As a result of this immediate market withdrawal request, ranitidine products will not be available for new or existing prescriptions or OTC use in the U.S.

BACKGROUND: Ranitidine is a histamine-2 blocker, which decreases the amount of acid created by the stomach. Prescription ranitidine is approved for multiple indications, including treatment and prevention of ulcers of the stomach and intestines and treatment of gastroesophageal reflux disease.

RECOMMENDATION:

  • Consumers: The FDA is also advising consumers taking OTC ranitidine to stop taking any tablets or liquid they currently have, dispose of them properly and not buy more; for those who wish to continue treating their condition, they should consider using other approved OTC products.

  • Patients: Patients taking prescription ranitidine should speak with their health care professional about other treatment options before stopping the medicine, as there are multiple drugs approved for the same or similar uses as ranitidine that do not carry the same risks from NDMA. To date, the FDA's testing has not found NDMA in famotidine (Pepcid), cimetidine (Tagamet), esomeprazole (Nexium), lansoprazole (Prevacid) or omeprazole (Prilosec).

  • Consumers and Patients: In light of the current COVID-19 pandemic, the FDA recommends patients and consumers not take their medicines to a drug take-back location but follow the FDA's recommended steps, available at: [Web], which include ways to safely dispose of these medications at home.

For more information visit the FDA website at: [Web] and [Web].

Side effects include:

Oral or parenteral therapy: Headache, sometimes severe.

IM therapy: Transient pain at injection site.

IV therapy: Transient local burning or itching.

Managing side effects (general information)

For Healthcare Professionals

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

General

The most commonly reported side effect for IM administration was injection site pain, and the most commonly reported side effects with IV administration were localized pain and burning.[Ref]

Gastrointestinal

Abdominal pain, constipation, and nausea tended to improve with continued treatment.[Ref]

Uncommon (0.1% to 1%): Abdominal discomfort/pain, constipation, nausea, vomiting

Very rare (less than 0.01%): Acute pancreatitis, diarrhea[Ref]

Cardiovascular

Rare (0.01% to 0.1%): Hypotension, chest pain, arrhythmia, bradycardia, atrioventricular block, tachycardia, premature ventricular beats

Very rare (less than 0.01%): Asystole, vasculitis[Ref]

Bradycardia, atrioventricular block, tachycardia, and asystole have occurred in H2 receptor antagonists.[Ref]

Psychiatric

Rare (0.01% to 0.1%): Insomnia, reversible mental confusion, agitation, depression, hallucinations

Frequency not reported: Loss of libido[Ref]

Nervous system

Headache may be related to administration of treatment.[Ref]

Rare (0.01% to 0.1%): Dizziness, somnolence, vertigo, reversible involuntary movement disorders

Very rare (less than 0.01%): Headache/severe headache[Ref]

Dermatologic

Rare (0.01% to 0.1%): Urticaria, angioneurotic edema, skin rash

Very rare (less than 0.01%): Erythema multiforme, alopecia[Ref]

Musculoskeletal

Very rare (less than 0.01%): Musculoskeletal symptoms, arthralgia, myalgia[Ref]

Hepatic

Rare (0.01% to 0.1%): Transient and reversible changes in liver function tests, increased ALT levels

Very rare (less than 0.01%): Hepatocellular/hepatocanalicular/mixed hepatitis with/without jaundice[Ref]

Hepatitis with/without jaundice were usually reversible.

ALT levels increased to at least 2 times the pretreatment levels in patients receiving high IV doses for at least 5 days.[Ref]

Other

Rare (0.01% to 0.1%): Fever, malaise

Frequency not reported: Death[Ref]

Hypersensitivity

Anaphylactic shock occurred after administration of a single dose.[Ref]

Rare (0.01% to 0.1%): Hypersensitivity reactions

Very rare (less than 0.01%): Anaphylactic shock/anaphylaxis[Ref]

Renal

Rare (0.01% to 0.1%): Elevation in serum creatinine

Very rare (less than 0.01%): Acute interstitial nephritis[Ref]

Elevation in serum creatinine was usually slight, and typically normalized with continued treatment.[Ref]

Respiratory

Rare (0.01% to 0.1%): Bronchospasm

Frequency not reported: Dyspnea, pneumonia[Ref]

Ocular

Rare (0.01% to 0.1%): Reversible blurred vision[Ref]

Hematologic

Very rare (less than 0.01%): Blood count changes, leukopenia, thrombocytopenia, granulocytopenia, agranulocytosis, pancytopenia, marrow hypoplasia/aplasia

Frequency not reported: Aplastic anemia, immune hemolytic anemia/acquired immune hemolytic anemia, eosinophilia[Ref]

Leukopenia, granulocytopenia, and thrombocytopenia were usually reversible.[Ref]

Genitourinary

Very rare (less than 0.01%): Reversible impotence, breast symptoms/conditions, galactorrhea[Ref]

Endocrine

Very rare (less than 0.01%): Gynecomastia[Ref]

Metabolic

Postmarketing reports: Acute porphyria[Ref]

Local

Frequency not reported: Injection site pain, transient localized burning or itching[Ref]

References

1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

2. "Product Information. Zantac 75 (ranitidine)." Pfizer U.S. Pharmaceuticals, New York, NY.

3. Cerner Multum, Inc. "Australian Product Information." O 0

4. "Product Information. Zantac (ranitidine)." Glaxo Wellcome, Research Triangle Park, NC.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer