CIMETIDINE

Cimetidine Adverse Events Reported to the FDA Over Time

How are Cimetidine adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Cimetidine, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Cimetidine is flagged as the suspect drug causing the adverse event.

Most Common Cimetidine Adverse Events Reported to the FDA

What are the most common Cimetidine adverse events reported to the FDA?

Drug Ineffective	207 (5.57%)
Drug Interaction	85 (2.29%)
Diarrhoea	84 (2.26%)
Dizziness	70 (1.88%)
Vomiting	51 (1.37%)
Rash	47 (1.26%)
Nausea	46 (1.24%)
Renal Failure Acute	39 (1.05%)
Abdominal Pain Upper	37 (1%)
Asthenia	36 (.97%)
Pyrexia	35 (.94%)
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Malaise	34 (.91%)
Dyspnoea	30 (.81%)
Drug Administration Error	29 (.78%)
Dyspepsia	29 (.78%)
Headache	29 (.78%)
Lactic Acidosis	29 (.78%)
Constipation	28 (.75%)
Urticaria	28 (.75%)
Depressed Level Of Consciousness	27 (.73%)
Abdominal Pain	26 (.7%)
Pruritus	25 (.67%)
Somnolence	25 (.67%)
Death	24 (.65%)
Tremor	23 (.62%)
Blood Glucose Increased	22 (.59%)
Fatigue	22 (.59%)
Vision Blurred	22 (.59%)
Drug Exposure During Pregnancy	21 (.57%)
Confusional State	20 (.54%)
Hypersensitivity	20 (.54%)
Hypertension	20 (.54%)
International Normalised Ratio Incr...	20 (.54%)
Pneumonia	20 (.54%)
Toxic Epidermal Necrolysis	20 (.54%)
Erythema	18 (.48%)
Blood Lactate Dehydrogenase Increas...	17 (.46%)
Blood Pressure Increased	17 (.46%)
Chest Pain	17 (.46%)
Condition Aggravated	17 (.46%)
Dysarthria	17 (.46%)
Feeling Abnormal	17 (.46%)
Circulatory Collapse	16 (.43%)
Haematoma	15 (.4%)
Hepatic Function Abnormal	15 (.4%)
Hypotension	15 (.4%)
Intentional Drug Misuse	15 (.4%)
Platelet Count Decreased	15 (.4%)
Swelling	15 (.4%)
Anaemia	14 (.38%)
Convulsion	14 (.38%)
Decreased Appetite	14 (.38%)
Haemolytic Anaemia	14 (.38%)
Blood Alkaline Phosphatase Increase...	13 (.35%)
Contusion	13 (.35%)
Dry Mouth	13 (.35%)
Hallucination	13 (.35%)
Hyperhidrosis	13 (.35%)
Hypoaesthesia	13 (.35%)
Overdose	13 (.35%)
Renal Impairment	13 (.35%)
Serotonin Syndrome	13 (.35%)
Agitation	12 (.32%)
Aspartate Aminotransferase Increase...	12 (.32%)
Balance Disorder	12 (.32%)
Acute Prerenal Failure	11 (.3%)
Alanine Aminotransferase Increased	11 (.3%)
Blood Bilirubin Increased	11 (.3%)
Depression	11 (.3%)
Faeces Discoloured	11 (.3%)
Gastrooesophageal Reflux Disease	11 (.3%)
Haemoglobin Decreased	11 (.3%)
Insomnia	11 (.3%)
Liver Disorder	11 (.3%)
Muscle Spasms	11 (.3%)
Pancreatitis Acute	11 (.3%)
Product Quality Issue	11 (.3%)
Abdominal Discomfort	10 (.27%)
Abdominal Distension	10 (.27%)
Anaphylactic Reaction	10 (.27%)
Back Pain	10 (.27%)
Blood Urea Increased	10 (.27%)
C-reactive Protein Increased	10 (.27%)
Chills	10 (.27%)
Cough	10 (.27%)
Drug Hypersensitivity	10 (.27%)
Drug Toxicity	10 (.27%)
Respiratory Arrest	10 (.27%)
Weight Decreased	10 (.27%)
White Blood Cell Count Decreased	10 (.27%)
Alopecia	9 (.24%)
Disseminated Intravascular Coagulat...	9 (.24%)
Epistaxis	9 (.24%)
Jaundice	9 (.24%)
Medication Error	9 (.24%)
Pancytopenia	9 (.24%)
Vertigo	9 (.24%)
Abortion Missed	8 (.22%)
Angioedema	8 (.22%)
Blood Creatinine Increased	8 (.22%)
Blood Potassium Decreased	8 (.22%)

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This graph shows the top adverse events submitted to the FDA for Cimetidine, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Cimetidine is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Cimetidine

What are the most common Cimetidine adverse events reported to the FDA?

Therapeutic And Nontherapeutic Effe...	318 (8.56%)
Gastrointestinal Signs	244 (6.57%)
Neurological	239 (6.43%)
Epidermal And Dermal Conditions	189 (5.09%)
Gastrointestinal Motility And Defec...	127 (3.42%)
Respiratory	111 (2.99%)
Hematology Investigations	99 (2.66%)
Medication Errors	80 (2.15%)
Renal Disorders	79 (2.13%)
Cardiac Arrhythmias	58 (1.56%)
Hepatic And Hepatobiliary	57 (1.53%)
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Cardiac And Vascular Investigations	56 (1.51%)
Infections - Pathogen Unspecified	55 (1.48%)
Allergic Conditions	54 (1.45%)
Hepatobiliary	51 (1.37%)
Metabolic, Nutritional And Blood Ga...	43 (1.16%)
Anxiety Disorders	39 (1.05%)
Enzyme	39 (1.05%)
Movement Disorders	39 (1.05%)
Renal And Urinary Tract Investigati...	38 (1.02%)
Chemical Injury And Poisoning	37 (1%)
Decreased And Nonspecific Blood Pre...	37 (1%)
Acid-base	36 (.97%)
Angiedema And Urticaria	36 (.97%)
Body Temperature Conditions	35 (.94%)
Urinary Tract Signs	33 (.89%)
Anemias Nonhemolytic And Marrow Dep...	32 (.86%)
Headaches	32 (.86%)
Skin Appendage Conditions	30 (.81%)
Neuromuscular	25 (.67%)
Oral Soft Tissue Conditions	25 (.67%)
Vision	25 (.67%)
Deliria	24 (.65%)
Fatal Outcomes	24 (.65%)
Injuries	24 (.65%)
Musculoskeletal And Connective Tiss...	24 (.65%)
Disturbances In Thinking	23 (.62%)
Physical Examination Topics	23 (.62%)
Vascular Hemorrhagic	23 (.62%)
Bone, Calcium, Magnesium And Phosph...	22 (.59%)
Electrolyte And Fluid Balance Condi...	22 (.59%)
Muscle	22 (.59%)
Nephropathies	22 (.59%)
Appetite And General Nutritional	21 (.57%)
Protein And Chemistry Analyses	21 (.57%)
Water, Electrolyte And Mineral	21 (.57%)
Central Nervous System Vascular	20 (.54%)
Vascular Hypertensive	20 (.54%)
Exocrine Pancreas Conditions	19 (.51%)
Immunology And Allergy	19 (.51%)
Psychiatric	19 (.51%)
Microbiology And Serology	18 (.48%)
Sleep Disorders	18 (.48%)
Lifestyle Issues	17 (.46%)
Seizures	17 (.46%)
Suicidal And Self-injurious Behavio...	17 (.46%)
Bacterial Infectious	16 (.43%)
Bronchial Disorders	16 (.43%)
Depressed Mood Disorders	16 (.43%)
Gastrointestinal Ulceration And Per...	16 (.43%)
Abortions And Stillbirth	15 (.4%)
Breast	14 (.38%)
Gastrointestinal Hemorrhages	14 (.38%)
Hemolyses And Related Conditions	14 (.38%)
Lower Respiratory Tract Disorders	13 (.35%)
Salivary Gland Conditions	13 (.35%)
Upper Respiratory Tract Disorders	13 (.35%)
Coagulopathies And Bleeding Diathes...	12 (.32%)
Ocular Infections, Irritations And ...	12 (.32%)
Vascular	12 (.32%)
White Blood Cell	12 (.32%)
Inner Ear And Viiith Cranial Nerve	11 (.3%)
Product Quality Issues	11 (.3%)
Gastrointestinal	10 (.27%)
Therapeutic Procedures And Supporti...	10 (.27%)
Tissue	10 (.27%)
Toxicology And Therapeutic Drug Mon...	10 (.27%)
Joint	9 (.24%)
Platelet	9 (.24%)
Coronary Artery	8 (.22%)
Gastrointestinal Inflammatory Condi...	8 (.22%)
Hematological And Lymphoid Tissue T...	8 (.22%)
Neurological, Special Senses And Ps...	8 (.22%)
Procedural And Device Related Injur...	8 (.22%)
Structural Brain	8 (.22%)
Eating Disorders	7 (.19%)
Fungal Infectious	7 (.19%)
Heart Failures	7 (.19%)
Mental Impairment	7 (.19%)
Schizophrenia And Other Psychotic	7 (.19%)
Aural	6 (.16%)
Changes In Physical Activity	6 (.16%)
Eye	6 (.16%)
Gastrointestinal Conditions	6 (.16%)
Glucose Metabolism Disorders	6 (.16%)
Skin And Subcutaneous Tissue	6 (.16%)
Viral Infectious	6 (.16%)
Bone And Joint Injuries	5 (.13%)
Cardiac Disorder Signs	5 (.13%)
Gastrointestinal Stenosis And Obstr...	5 (.13%)
Immune	5 (.13%)

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This graph shows the top categories of adverse events submitted to the FDA for Cimetidine, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Cimetidine is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.