ADVERSE REACTIONS
The following have been reported as events in clinical trials or in the routine management of patients treated with ranitidine. The relationship to therapy with ranitidine has been unclear in many cases. Headache, sometimes severe, seems to be related to administration of ranitidine.
Central Nervous System:
Rarely, malaise, dizziness, somnolence, insomnia, and vertigo. Rare cases of reversible mental confusion, agitation, depression, and hallucinations have been reported, predominantly in severely ill elderly patients. Rare cases of reversible blurred vision suggestive of a change in accommodation have been reported. Rare reports of reversible involuntary motor disturbances have been received.
Cardiovascular:
As with other H2-blockers, rare reports of arrhythmias such as tachycardia, bradycardia, atrioventricular block, and premature ventricular beats.
Gastrointestinal:
Constipation, diarrhea, nausea/vomiting, abdominal discomfort/ pain, and rare reports of pancreatitis.
Hepatic:
There have been occasional reports of hepatocellular, cholestatic, or mixed hepatitis, with or without jaundice. In such circumstances, ranitidine should be immediately discontinued. These events are usually reversible, but in rare circumstances death has occurred. Rare cases of hepatic failure have also been reported. In normal volunteers, SGPT values were increased to at least twice the pretreatment levels in 6 of 12 subjects receiving 100 mg q.i.d. intravenously for 7 days, and in 4 of 24 subjects receiving 50 mg q.i.d. intravenously for 5 days.
Musculoskeletal:
Rare reports of arthralgias and myalgias.
Hematologic:
Blood count changes (leukopenia, granulocytopenia, and thrombocytopenia) have occurred in a few patients. These were usually reversible. Rare cases of agranulocytosis, pancytopenia, sometimes with marrow hypoplasia, and aplastic anemia and exceedingly rare cases of acquired immune hemolytic anemia have been reported.
Endocrine:
Controlled studies in animals and man have shown no stimulation of any pituitary hormone by ranitidine and no antiandrogenic activity, and cimetidine-induced gynecomastia and impotence in hyper-secretory patients have resolved when ranitidine has been substituted. However, occasional cases of gynecomastia, impotence, and loss of libido have been reported in male patients receiving ranitidine, but the incidence did not differ from that in the general population.
Integumentary:
Rash, including rare cases of erythema multiforme. Rare cases of alopecia and vasculitis.
Other:
Rare cases of hypersensitivity reactions (e.g., bronchospasm, fever, rash, eosinophilia), anaphylaxis, angioneurotic edema, and small increases in serum creatinine.
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REPORTS OF SIDE EFFECTS / ADVERSE REACTIONS RELATED TO RANITIDINE
Below is a sample of reports where side effects / adverse reactions may be related to Ranitidine. The information is not vetted and should not be cosidered as verified clinical evidence.
Possible Ranitidine side effects / adverse reactions in 85 year old female
Reported by a health professional (non-physician/pharmacist) from France on 2007-01-12
Patient: 85 year old female weighing 150.0 kg (330.0 pounds)
Reactions: Ventricular Extrasystoles, Cardiac Failure, Supraventricular Extrasystoles, Pulmonary Oedema, Hypertension
Adverse event resulted in: hospitalization
Suspect drug(s):
Solu-Medrol
Dosage: daily dose:120mg-text:120mg/2ml
Paclitaxel
Dosage: daily dose:250mg
Indication: Breast Cancer
Ranitidine
Dosage: daily dose:50mg
Dexchlorpheniramine
Dosage: daily dose:5mg
Trastuzumab
Dosage: daily dose:800mg
Indication: Breast Cancer
Possible Ranitidine side effects / adverse reactions in 42 year old male
Reported by a consumer/non-health professional from Switzerland on 2007-01-15
Patient: 42 year old male weighing 93.0 kg (204.6 pounds)
Reactions: Blood Alkaline Phosphatase Increased, Blood Bilirubin Increased, Jaundice, Gamma-Glutamyltransferase Increased, Liver Function Test Abnormal, Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased
Adverse event resulted in: hospitalization
Suspect drug(s):
Ranitidine
Other drugs received by patient: Inderal; Konakion; Pantoprazol
Possible Ranitidine side effects / adverse reactions in 54 year old male
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2007-01-16
Patient: 54 year old male
Reactions: Overdose, Haemodynamic Instability
Adverse event resulted in: hospitalization
Suspect drug(s):
Zocor
Administration route: Oral
Zocor
Administration route: Oral
Ranitidine
Administration route: Oral
Ranitidine
Administration route: Oral
Ramipril
Administration route: Oral
Ramipril
Administration route: Oral
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