Applies to ranitidine: oral capsule, oral suspension reconstituted, oral syrup, oral tablet. Other dosage forms:

• injection solution

Serious side effects of Ranitidine

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.

Other side effects of Ranitidine

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Headache.
• Constipation, diarrhea, stomach pain, upset stomach, or throwing up.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

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]