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Nizatidine Side Effects

For the Consumer

Applies to nizatidine: oral capsules, oral tablets for

Side effects include:

Headache, dizziness.

For Healthcare Professionals

Applies to nizatidine: oral capsule, oral solution, oral tablet

General

The most commonly reported side effects included headache, rhinitis, abdominal pain, and diarrhea.[Ref]

Nervous system

Very common (10% or more): Headache (up to 16.6%)

Common (1% to 10%): Dizziness, somnolence

Frequency not reported: Seizure[Ref]

A pediatric patient given 2.5 mg/kg orally 2 times a day for 23 days experienced an EEG-diagnosed seizure during treatment.[Ref]

Gastrointestinal

Common (1% to 10%): Constipation, diarrhea, dry mouth, dyspepsia, flatulence, gastrointestinal disorder, nausea, nausea and vomiting, tooth disorder, vomiting[Ref]

Respiratory

Common (1% to 10%): Cough, cough increased, nasal congestion, nasopharyngitis, pharyngitis, rhinitis, sinusitis

Postmarketing reports: Bronchospasm, laryngeal edema[Ref]

Other

Common (1% to 10%): Accident, asthenia, fever, injury, pain, pyrexia, surgical procedure[Ref]

Psychiatric

Common (1% to 10%): Abnormal dreams, anxiety, insomnia, irritability, nervousness

Postmarketing reports: Decreased libido, reversible mental confusion[Ref]

Dermatologic

Common (1% to 10%): Pruritus, rash, sweating, urticaria

Postmarketing reports: Exfoliative dermatitis[Ref]

Musculoskeletal

Common (1% to 10%): Back pain, myalgia

Postmarketing reports: Arthralgia[Ref]

Immunologic

Common (1% to 10%): Infection

Rare (0.01% to 0.1%): Serum sickness, serum sickness-like reactions[Ref]

Cardiovascular

Common (1% to 10%): Chest pain

Frequency not reported: Short episodes of asymptomatic ventricular tachycardia

Postmarketing reports: Vasculitis[Ref]

Metabolic

Common (1% to 10%): Anorexia

Postmarketing reports: Hyperuricemia unrelated to gout or nephrolithiasis[Ref]

Ocular

Common (1% to 10%): Amblyopia[Ref]

Hematologic

Uncommon (0.1% to 1%): Anemia

Postmarketing reports: Agranulocytosis, eosinophilia, fatal thrombocytopenia, leukopenia, thrombocytopenic purpura[Ref]

Fatal thrombocytopenia was reported in a patient who experienced possible drug-related thrombocytopenia previously received this drug and another histamine-2 (H2) receptor antagonist.[Ref]

Hepatic

Some patients developed ALT and/or AST elevations exceeding 500 international units/L, with a report of an ALT level exceeding 2000 international units/L.

Some patients 2 to 18 years developed mild elevations in serum transaminase levels (1 to 2 times the upper limit of normal).

Liver enzyme elevations and liver abnormalities were reversible upon discontinuation of treatment.[Ref]

Rare (0.01% to 0.1%): Transient, marked transaminase elevations, transient, marked alkaline phosphatase elevations

Frequency not reported: Elevated liver enzyme tests (alkaline phosphatase, ALT, AST), hepatocellular injury, transient, asymptomatic transaminase elevations, transient, asymptomatic alkaline phosphatase elevations

Postmarketing reports: Cholestatic injury, cholestatic injury with jaundice, hepatitis, jaundice, mixed hepatocellular injury, mixed hepatocellular injury with jaundice[Ref]

Hypersensitivity

Hypersensitivity reactions included bronchospasm, eosinophilia, laryngeal edema, and rash.[Ref]

Postmarketing reports: Anaphylaxis, hypersensitivity reactions[Ref]

Genitourinary

Postmarketing reports: Impotence[Ref]

Endocrine

Postmarketing reports: Gynecomastia[Ref]

References

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

2. "Product Information. Axid (nizatidine)." Lilly, Eli and Company, Indianapolis, IN.

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.