Tagamet HB Side Effects
Generic Name: cimetidine
Note: This document contains side effect information about cimetidine. Some of the dosage forms listed on this page may not apply to the brand name Tagamet HB.
More frequent side effects include: gynecomastia. See below for a comprehensive list of adverse effects.
For the Consumer
Applies to cimetidine: oral liquid and tablets, parenteral injection, parenteral injection for iv infusion only
Side effects include:
With ≥1 month of therapy: gynecomastia.
With IM therapy: transient pain at injection site.
For Healthcare Professionals
Applies to cimetidine: compounding powder, intravenous solution, oral liquid, oral tablet
Very common (10% or more): Increased plasma creatinine (up to 11%)
Rare (0.01% to 0.1%): Interstitial nephritis[Ref]
Interstitial nephritis cleared with drug withdrawal.
Creatinine elevations usually occurred during the first week of treatment and were typically non-progressive, with values returning to pretreatment levels during therapy or up to 1 week after stopping treatment.[Ref]
Pancreatitis cleared with drug withdrawal.[Ref]
Common (1% to 10%): Musculoskeletal pain, myalgia/reversible myalgia
Rare (0.01% to 0.1%): Arthralgia/reversible arthralgia, exacerbation of joint symptoms, polymyositis[Ref]
Common (1% to 10%): Dizziness, drowsiness, headache[Ref]
Headaches occurred more frequently in patients given 1600 mg/day compared to patients given 800 mg/day.
Somnolence and dizziness were usually mild and have been reported in patients receiving 800 to 1600 mg/day.[Ref]
Common (1% to 10%): Rash/skin rashes
Rare (0.01% to 0.1%): Hypersensitivity vasculitis
Hypersensitivity vasculitis usually cleared with drug withdrawal.[Ref]
Fever cleared with drug withdrawal.[Ref]
Common (1% to 10%): Tiredness
Rare (0.01% to 0.1%): Fever[Ref]
Confusional states occurred within 2 to 3 days of starting treatment, were reversible within 3 to 4 days of stopping treatment and were more commonly reported in elderly patients and/or ill patients (e.g., renal dysfunction, organic brain syndrome).[Ref]
Uncommon (0.1% to 1%): Confusional state, depression, hallucination
Uncommon (0.1% to 1%): Hepatitis, reversible liver damage
Rare (0.01% to 0.1%): Cholestatic effects, increased serum transaminases, mixed cholestatic-hepatocellular effects
Very rare (less than 0.01%): Fatal hepatic effects
Frequency not reported: Periportal hepatic fibrosis, severe parenchymal injury[Ref]
Hepatitis and serum transaminase level elevations cleared with drug withdrawal.
Fatal hepatic effects have occurred with other histamine-2 receptor antagonists.
Severe parenchymal injury is considered highly unlikely due to the predominance of cholestatic features.
There was a report of biopsy-proven periportal hepatic fibrosis in a patient receiving this drug.[Ref]
Uncommon (0.1% to 1%): Leukopenia
Leukopenia and/or thrombocytopenia were reversible with withdrawal of treatment.
Agranulocytosis/decreased white blood cell counts have been reported, with some events recurring upon rechallenge. These events were more commonly reported in patients with serious concomitant illnesses and/or those who received drugs/treatments known to produce neutropenia.[Ref]
Uncommon (0.1% to 1%): Tachycardia
Uncommon (0.1% to 1%): Reversible impotence
Rare (0.01% to 0.1%): Urinary retention
Very rare (less than 0.01%): Galactorrhea[Ref]
Urinary retention cleared with drug withdrawal.[Ref]
Uncommon (0.1% to 1%): Gynecomastia[Ref]
Rare (0.01% to 0.1%): Allergic reactions, anaphylaxis[Ref]
Very rare (less than 0.01%): Strongyloidiasis hyperinfection[Ref]
In a large epidemiological study, it was suggested that patients taking histamine-2-receptor antagonists had an increased adjusted relative risk of 1.63 (95% confidence interval of 1.07 to 2.48) of developing pneumonia compared to patients who stopped treatment. However, causal relationship between H2RA use and pneumonia has not been established.[Ref]
Frequency not reported: Pneumonia[Ref]
1. "Product Information. Tagamet HB (cimetidine)." SmithKline Beecham, Philadelphia, PA.
2. "Product Information. Tagamet (cimetidine)." SmithKline Beecham, Philadelphia, PA.
3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
4. Cerner Multum, Inc. "Australian Product Information." O 0
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.
More about Tagamet HB (cimetidine)
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- Drug class: H2 antagonists