Berkley and Jensen Acid Reducer Maximum Strength

Ranitidine 150 mg (as ranitidine hydrochloride 168 mg)

Acid reducer

• do not use if printed foil under cap is broken or missing
• avoid excessive heat or humidity
• store at 20° - 25°C (68° - 77°F)
• this product is sugar free

1-800-934-1204

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

Uncommon (0.1% to 1%): Abdominal discomfort/pain, constipation, nausea, vomiting
Very rare (less than 0.01%): Acute pancreatitis, diarrhea[Ref]

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

Rare (0.01% to 0.1%): Hypersensitivity reactions
Very rare (less than 0.01%): Anaphylactic shock/anaphylaxis[Ref]

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

Some side effects of Berkley and Jensen Acid Reducer Maximum Strength may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.