FAMOTIDINE

Famotidine Adverse Events Reported to the FDA Over Time

How are Famotidine adverse event reports trending over time?

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

Most Common Famotidine Adverse Events Reported to the FDA

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

Liver Disorder	80 (1.82%)
Alanine Aminotransferase Increased	68 (1.54%)
Aspartate Aminotransferase Increase...	65 (1.48%)
Pyrexia	61 (1.39%)
Hepatic Function Abnormal	59 (1.34%)
Nausea	59 (1.34%)
Platelet Count Decreased	57 (1.29%)
Thrombocytopenia	42 (.95%)
Vomiting	41 (.93%)
Condition Aggravated	39 (.89%)
White Blood Cell Count Decreased	39 (.89%)
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Malaise	38 (.86%)
Delirium	37 (.84%)
Dehydration	36 (.82%)
Anorexia	35 (.8%)
Drug Rash With Eosinophilia And Sys...	35 (.8%)
Toxic Epidermal Necrolysis	35 (.8%)
Interstitial Lung Disease	31 (.7%)
Drug Interaction	30 (.68%)
Pancytopenia	29 (.66%)
Rash	28 (.64%)
Decreased Appetite	27 (.61%)
Renal Impairment	26 (.59%)
Death	25 (.57%)
Drug Ineffective	25 (.57%)
Hepatitis	25 (.57%)
Anaemia	24 (.55%)
Fatigue	24 (.55%)
Torsade De Pointes	24 (.55%)
Blood Lactate Dehydrogenase Increas...	23 (.52%)
Drug Eruption	23 (.52%)
Jaundice	23 (.52%)
Agranulocytosis	22 (.5%)
Blood Bilirubin Increased	22 (.5%)
Gamma-glutamyltransferase Increased	22 (.5%)
Stevens-johnson Syndrome	22 (.5%)
Dizziness	21 (.48%)
Electrocardiogram Qt Prolonged	21 (.48%)
Fall	21 (.48%)
Blood Alkaline Phosphatase Increase...	20 (.45%)
Neutrophil Count Decreased	20 (.45%)
Cardiac Arrest	19 (.43%)
Heart Rate Increased	19 (.43%)
Respiratory Arrest	19 (.43%)
Sepsis	19 (.43%)
Blood Pressure Increased	18 (.41%)
Medication Error	18 (.41%)
Confusional State	17 (.39%)
Dyspnoea	17 (.39%)
Haemoglobin Decreased	17 (.39%)
Hepatitis Acute	17 (.39%)
Poisoning	17 (.39%)
Completed Suicide	16 (.36%)
Diarrhoea	16 (.36%)
Multi-organ Failure	16 (.36%)
Myocardial Infarction	16 (.36%)
Renal Failure	16 (.36%)
Rhabdomyolysis	16 (.36%)
Urticaria	16 (.36%)
Cardiac Failure	15 (.34%)
Disseminated Intravascular Coagulat...	15 (.34%)
Drug Toxicity	15 (.34%)
Gastrointestinal Haemorrhage	15 (.34%)
Hypertension	15 (.34%)
Renal Failure Acute	15 (.34%)
Alopecia	14 (.32%)
Blood Creatinine Increased	14 (.32%)
Bradycardia	14 (.32%)
Convulsion	14 (.32%)
Headache	14 (.32%)
Oedema Peripheral	14 (.32%)
Overdose	14 (.32%)
Acute Myocardial Infarction	13 (.3%)
Cerebral Infarction	13 (.3%)
Drug Hypersensitivity	13 (.3%)
Eosinophil Count Increased	13 (.3%)
Lymphocyte Stimulation Test Positiv...	13 (.3%)
Pneumonia	13 (.3%)
Pruritus	13 (.3%)
Stomatitis	13 (.3%)
Asthenia	12 (.27%)
Asthma	12 (.27%)
Dyspepsia	12 (.27%)
Erythema	12 (.27%)
Erythema Multiforme	12 (.27%)
Neutropenia	12 (.27%)
Renal Disorder	12 (.27%)
Blood Creatine Phosphokinase Increa...	11 (.25%)
Blood Pressure Decreased	11 (.25%)
C-reactive Protein Increased	11 (.25%)
Diabetes Mellitus	11 (.25%)
Hepatic Enzyme Increased	11 (.25%)
Liver Function Test Abnormal	11 (.25%)
Oedema	11 (.25%)
White Blood Cell Count Increased	11 (.25%)
Anaphylactic Reaction	10 (.23%)
Constipation	10 (.23%)
Haemorrhage	10 (.23%)
Hypoglycaemia	10 (.23%)
Hypokalaemia	10 (.23%)
Impaired Gastric Emptying	10 (.23%)

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This graph shows the top adverse events submitted to the FDA for Famotidine, 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 Famotidine 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 Famotidine

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

Epidermal And Dermal Conditions	256 (5.82%)
Hepatic And Hepatobiliary	253 (5.75%)
Hematology Investigations	247 (5.61%)
Hepatobiliary	203 (4.61%)
Gastrointestinal Signs	151 (3.43%)
Cardiac Arrhythmias	143 (3.25%)
Neurological	112 (2.54%)
Respiratory	102 (2.32%)
Infections - Pathogen Unspecified	99 (2.25%)
Renal Disorders	98 (2.23%)
Cardiac And Vascular Investigations	86 (1.95%)
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Therapeutic And Nontherapeutic Effe...	85 (1.93%)
Appetite And General Nutritional	80 (1.82%)
Anemias Nonhemolytic And Marrow Dep...	71 (1.61%)
Body Temperature Conditions	68 (1.54%)
Electrolyte And Fluid Balance Condi...	66 (1.5%)
Lower Respiratory Tract Disorders	65 (1.48%)
White Blood Cell	65 (1.48%)
Medication Errors	62 (1.41%)
Deliria	60 (1.36%)
Enzyme	59 (1.34%)
Gastrointestinal Motility And Defec...	51 (1.16%)
Platelet	50 (1.14%)
Chemical Injury And Poisoning	45 (1.02%)
Coronary Artery	43 (.98%)
Renal And Urinary Tract Investigati...	41 (.93%)
Allergic Conditions	40 (.91%)
Injuries	37 (.84%)
Muscle	35 (.8%)
Bacterial Infectious	34 (.77%)
Movement Disorders	32 (.73%)
Protein And Chemistry Analyses	32 (.73%)
Central Nervous System Vascular	29 (.66%)
Fungal Infectious	29 (.66%)
Mental Impairment	29 (.66%)
Gastrointestinal Ulceration And Per...	26 (.59%)
Angiedema And Urticaria	25 (.57%)
Coagulopathies And Bleeding Diathes...	25 (.57%)
Fatal Outcomes	25 (.57%)
Glucose Metabolism Disorders	24 (.55%)
Gastrointestinal Hemorrhages	23 (.52%)
Suicidal And Self-injurious Behavio...	23 (.52%)
Skin Appendage Conditions	22 (.5%)
Musculoskeletal And Connective Tiss...	21 (.48%)
Physical Examination Topics	21 (.48%)
Metabolic, Nutritional And Blood Ga...	20 (.45%)
Oral Soft Tissue Conditions	20 (.45%)
Decreased And Nonspecific Blood Pre...	19 (.43%)
Heart Failures	19 (.43%)
Seizures	19 (.43%)
Water, Electrolyte And Mineral	19 (.43%)
Cardiac Disorder Signs	18 (.41%)
Eye	18 (.41%)
Nephropathies	18 (.41%)
Procedural And Device Related Injur...	18 (.41%)
Product Quality Issues	18 (.41%)
Sleep Disorders	18 (.41%)
Viral Infectious	18 (.41%)
Bronchial Disorders	17 (.39%)
Disturbances In Thinking	17 (.39%)
Gastrointestinal Inflammatory Condi...	16 (.36%)
Hematological And Lymphoid Tissue T...	16 (.36%)
Anxiety Disorders	15 (.34%)
Embolism And Thrombosis	15 (.34%)
Psychiatric	15 (.34%)
Urinary Tract Signs	15 (.34%)
Vascular Hypertensive	15 (.34%)
Bone And Joint Injuries	14 (.32%)
Encephalopathies	14 (.32%)
Headaches	14 (.32%)
Hemolyses And Related Conditions	13 (.3%)
Therapeutic Procedures And Supporti...	13 (.3%)
Upper Respiratory Tract Disorders	13 (.3%)
Administration Site Reactions	11 (.25%)
Microbiology And Serology	11 (.25%)
Ocular Infections, Irritations And ...	11 (.25%)
Peripheral Neuropathies	11 (.25%)
Pulmonary Vascular	11 (.25%)
Immunology And Allergy	10 (.23%)
Joint	10 (.23%)
Lifestyle Issues	10 (.23%)
Personality Disorders	10 (.23%)
Toxicology And Therapeutic Drug Mon...	10 (.23%)
Vascular Hemorrhagic	10 (.23%)
Breast	9 (.2%)
Gastrointestinal Conditions	9 (.2%)
Miscellaneous And Site Unspecified ...	9 (.2%)
Neonatal And Perinatal Conditions	9 (.2%)
Psychiatric And Behavioural Symptom...	9 (.2%)
Vascular	9 (.2%)
Vision	9 (.2%)
Gallbladder	8 (.18%)
Gastrointestinal Neoplasms Malignan...	8 (.18%)
Skin And Subcutaneous Tissue	8 (.18%)
Skin Vascular Abnormalities	8 (.18%)
Thyroid Gland	8 (.18%)
Urolithiases	8 (.18%)
Gastrointestinal Stenosis And Obstr...	7 (.16%)
Mood Disorders	7 (.16%)
Peritoneal And Retroperitoneal Cond...	7 (.16%)
Protein And Amino Acid Metabolism	7 (.16%)

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This graph shows the top categories of adverse events submitted to the FDA for Famotidine, 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 Famotidine 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.