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More frequently reported 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:
Headache, dizziness, somnolence, diarrhea.
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 tabletRenal
Very common (10% or more): Increased plasma creatinine (up to 11%)
Rare (0.01% to 0.1%): Interstitial nephritis
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.Gastrointestinal
Common (1% to 10%): Constipation, diarrhea, flatulence, nausea, vomiting
Rare (0.01% to 0.1%): Acute pancreatitis/pancreatitis
Pancreatitis cleared with drug withdrawal.Musculoskeletal
Common (1% to 10%): Musculoskeletal pain, myalgia/reversible myalgia
Rare (0.01% to 0.1%): Arthralgia/reversible arthralgia, exacerbation of joint symptoms, polymyositisNervous system
Common (1% to 10%): Dizziness, drowsiness, headache
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.Dermatologic
Hypersensitivity vasculitis usually cleared with drug withdrawal.
Common (1% to 10%): Rash/skin rashes
Rare (0.01% to 0.1%): Hypersensitivity vasculitis
Very rare (less than 0.01%): Epidermal necrolysis, erythema multiforme, generalized exfoliative erythroderma, reversible alopecia, severe generalized skin reactions, Stevens-Johnson syndrome
Frequency not reported: Severe skin rashOther
Fever cleared with drug withdrawal.
Common (1% to 10%): Tiredness
Rare (0.01% to 0.1%): FeverPsychiatric
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).
Uncommon (0.1% to 1%): Confusional state, depression, hallucination
Frequency not reported: Agitation, anxiety, disorientation, mental confusion, psychosisHepatic
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.
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 injuryHematologic
Uncommon (0.1% to 1%): Leukopenia
Rare (0.01% to 0.1%): Agranulocytosis, aplastic anemia, decreased white blood cell counts, pancytopenia, thrombocytopenia
Very rare (less than 0.01%): Immune hemolytic anemia
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.Cardiovascular
Uncommon (0.1% to 1%): Tachycardia
Rare (0.01% to 0.1%): Atrioventricular (AV) heart block/heart block, sinus bradycardiaGenitourinary
Urinary retention cleared with drug withdrawal.
Uncommon (0.1% to 1%): Reversible impotence
Rare (0.01% to 0.1%): Urinary retention
Very rare (less than 0.01%): GalactorrheaEndocrine
Uncommon (0.1% to 1%): GynecomastiaHypersensitivity
Allergic reactions and anaphylaxis usually cleared with drug withdrawal.
Rare (0.01% to 0.1%): Allergic reactions, anaphylaxisImmunologic
Very rare (less than 0.01%): Strongyloidiasis hyperinfectionRespiratory
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.
Frequency not reported: Pneumonia
February 16, 2021
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August 31, 2020