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.
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.
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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.