ZANTAC

Adverse Events

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Zantac Adverse Events Reported to the FDA Over Time

How are Zantac adverse event reports trending over time?

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

Most Common Zantac Adverse Events Reported to the FDA

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

Drug Ineffective	1298 (5.28%)
Diarrhoea	412 (1.68%)
Vomiting	404 (1.64%)
Dyspepsia	396 (1.61%)
Nausea	383 (1.56%)
Dyspnoea	377 (1.53%)
Dizziness	295 (1.2%)
Abdominal Pain Upper	287 (1.17%)
Pruritus	240 (.98%)
Headache	226 (.92%)
Chest Pain	214 (.87%)
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Overdose	213 (.87%)
Malaise	212 (.86%)
Rash	197 (.8%)
Urticaria	191 (.78%)
Fatigue	187 (.76%)
Abdominal Pain	186 (.76%)
Hypotension	174 (.71%)
Anaphylactic Reaction	164 (.67%)
Loss Of Consciousness	162 (.66%)
Gastrooesophageal Reflux Disease	155 (.63%)
Drug Screen Positive	154 (.63%)
Pyrexia	153 (.62%)
Drug Exposure During Pregnancy	151 (.61%)
Accidental Overdose	141 (.57%)
Anaphylactic Shock	141 (.57%)
Constipation	140 (.57%)
Medication Error	129 (.52%)
Flatulence	125 (.51%)
Erythema	122 (.5%)
Chest Discomfort	120 (.49%)
Dysgeusia	119 (.48%)
Drug Interaction	113 (.46%)
Abdominal Discomfort	112 (.46%)
Confusional State	112 (.46%)
Insomnia	112 (.46%)
Feeling Abnormal	106 (.43%)
Hypersensitivity	106 (.43%)
Accidental Drug Intake By Child	102 (.41%)
Incorrect Dose Administered	100 (.41%)
Blood Pressure Decreased	99 (.4%)
Circulatory Collapse	97 (.39%)
Asthenia	96 (.39%)
Pain	93 (.38%)
Dry Mouth	92 (.37%)
Anxiety	91 (.37%)
Cardiac Arrest	90 (.37%)
Faeces Discoloured	90 (.37%)
Abdominal Distension	89 (.36%)
Tremor	87 (.35%)
Alanine Aminotransferase Increased	86 (.35%)
Somnolence	86 (.35%)
Condition Aggravated	85 (.35%)
Drug Screen False Positive	85 (.35%)
Tachycardia	85 (.35%)
Blood Pressure Increased	84 (.34%)
Hypertension	82 (.33%)
Pain In Extremity	82 (.33%)
Arthralgia	79 (.32%)
Completed Suicide	79 (.32%)
Convulsion	79 (.32%)
Oxygen Saturation Decreased	79 (.32%)
Burning Sensation	75 (.3%)
Anaemia	74 (.3%)
Neutropenia	74 (.3%)
Aspartate Aminotransferase Increase...	73 (.3%)
Paraesthesia	73 (.3%)
Renal Failure Acute	73 (.3%)
Hyperhidrosis	72 (.29%)
Thrombocytopenia	72 (.29%)
Weight Decreased	72 (.29%)
Drug Effect Decreased	71 (.29%)
Cough	70 (.28%)
Eructation	70 (.28%)
Oedema Peripheral	69 (.28%)
Muscle Spasms	67 (.27%)
Shock	67 (.27%)
Blood Glucose Increased	65 (.26%)
Heart Rate Increased	65 (.26%)
Product Quality Issue	65 (.26%)
Agitation	64 (.26%)
Back Pain	64 (.26%)
Hypoaesthesia	64 (.26%)
Palpitations	63 (.26%)
Swelling Face	63 (.26%)
Throat Irritation	62 (.25%)
Pneumonia	60 (.24%)
Cyanosis	59 (.24%)
Myalgia	59 (.24%)
Drug Hypersensitivity	58 (.24%)
Flushing	57 (.23%)
Respiratory Arrest	57 (.23%)
Rhabdomyolysis	57 (.23%)
Dysphagia	56 (.23%)
Glossodynia	55 (.22%)
Vision Blurred	54 (.22%)
Angioedema	53 (.22%)
Lethargy	53 (.22%)
Depressed Level Of Consciousness	51 (.21%)
Urine Amphetamine Positive	50 (.2%)
Alopecia	49 (.2%)

Share/Embed Graph Export Data

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

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

Gastrointestinal Signs	2353 (9.57%)
Therapeutic And Nontherapeutic Effe...	1648 (6.7%)
Neurological	1324 (5.38%)
Epidermal And Dermal Conditions	1224 (4.98%)
Respiratory	1086 (4.42%)
Medication Errors	1018 (4.14%)
Gastrointestinal Motility And Defec...	761 (3.09%)
Allergic Conditions	544 (2.21%)
Cardiac Arrhythmias	444 (1.81%)
Cardiac And Vascular Investigations	421 (1.71%)
Toxicology And Therapeutic Drug Mon...	381 (1.55%)
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Infections - Pathogen Unspecified	370 (1.5%)
Decreased And Nonspecific Blood Pre...	356 (1.45%)
Hematology Investigations	328 (1.33%)
Hepatic And Hepatobiliary	299 (1.22%)
Hepatobiliary	269 (1.09%)
Chemical Injury And Poisoning	262 (1.07%)
Muscle	257 (1.04%)
Angiedema And Urticaria	249 (1.01%)
Headaches	248 (1.01%)
Anxiety Disorders	246 (1%)
Musculoskeletal And Connective Tiss...	246 (1%)
Movement Disorders	222 (.9%)
Metabolic, Nutritional And Blood Ga...	211 (.86%)
Renal Disorders	208 (.85%)
Skin Appendage Conditions	194 (.79%)
White Blood Cell	183 (.74%)
Deliria	170 (.69%)
Oral Soft Tissue Conditions	169 (.69%)
Upper Respiratory Tract Disorders	167 (.68%)
Injuries	164 (.67%)
Lower Respiratory Tract Disorders	164 (.67%)
Sleep Disorders	164 (.67%)
Body Temperature Conditions	162 (.66%)
Anemias Nonhemolytic And Marrow Dep...	158 (.64%)
Bronchial Disorders	155 (.63%)
Tongue Conditions	153 (.62%)
Vascular	145 (.59%)
Cardiac Disorder Signs	142 (.58%)
Urinary Tract Signs	137 (.56%)
Physical Examination Topics	134 (.54%)
Suicidal And Self-injurious Behavio...	127 (.52%)
Appetite And General Nutritional	125 (.51%)
Salivary Gland Conditions	119 (.48%)
Seizures	116 (.47%)
Joint	111 (.45%)
Vision	110 (.45%)
Electrolyte And Fluid Balance Condi...	107 (.44%)
Product Quality Issues	106 (.43%)
Gastrointestinal Hemorrhages	105 (.43%)
Bacterial Infectious	100 (.41%)
Procedural And Device Related Injur...	99 (.4%)
Enzyme	98 (.4%)
Platelet	97 (.39%)
Mental Impairment	95 (.39%)
Water, Electrolyte And Mineral	94 (.38%)
Disturbances In Thinking	90 (.37%)
Psychiatric	87 (.35%)
Renal And Urinary Tract Investigati...	87 (.35%)
Coronary Artery	85 (.35%)
Gastrointestinal Conditions	83 (.34%)
Vascular Hypertensive	82 (.33%)
Neonatal And Perinatal Conditions	77 (.31%)
Ocular Infections, Irritations And ...	73 (.3%)
Eye	72 (.29%)
Central Nervous System Vascular	67 (.27%)
Gastrointestinal Ulceration And Per...	64 (.26%)
Ocular Neuromuscular	64 (.26%)
Dental And Gingival Conditions	61 (.25%)
Lifestyle Issues	59 (.24%)
Pleural	58 (.24%)
Fatal Outcomes	57 (.23%)
Administration Site Reactions	56 (.23%)
Depressed Mood Disorders	56 (.23%)
Inner Ear And Viiith Cranial Nerve	56 (.23%)
Gastrointestinal Inflammatory Condi...	54 (.22%)
Glucose Metabolism Disorders	53 (.22%)
Mood Disorders	53 (.22%)
Skin Vascular Abnormalities	53 (.22%)
Bone Disorders	52 (.21%)
Bone, Calcium, Magnesium And Phosph...	52 (.21%)
Viral Infectious	49 (.2%)
Nephropathies	48 (.2%)
Exocrine Pancreas Conditions	47 (.19%)
Immunology And Allergy	46 (.19%)
Heart Failures	45 (.18%)
Maternal Complications Of Labour An...	44 (.18%)
Vascular Hemorrhagic	44 (.18%)
Protein And Chemistry Analyses	43 (.17%)
Pulmonary Vascular	43 (.17%)
Obstetric And Gynecological Therape...	41 (.17%)
Bone And Joint Injuries	39 (.16%)
Therapeutic Procedures And Supporti...	36 (.15%)
Neurological, Special Senses And Ps...	35 (.14%)
Neuromuscular	34 (.14%)
Gallbladder	31 (.13%)
Musculoskeletal And Connective Tiss...	30 (.12%)
Pregnancy, Labour, Delivery And Pos...	30 (.12%)
Changes In Physical Activity	29 (.12%)
Peripheral Neuropathies	29 (.12%)
Embolism And Thrombosis	28 (.11%)

Share/Embed Graph Export Data

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

Common Uses of Zantac According to Those Reporting Adverse Events

Why are people taking Zantac, according to those reporting adverse events to the FDA?

Gastrooesophageal Reflux Disease	2678
Dyspepsia	2664
Drug Use For Unknown Indication	2075
Product Used For Unknown Indication	1467
Premedication	902
Prophylaxis	850
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Gastritis	516
Gastric Disorder	385
Prophylaxis Against Gastrointestina...	330
Gastric Ulcer	281
Abdominal Pain Upper	189
Ulcer	167
Abdominal Discomfort	159
Ill-defined Disorder	149
Hyperchlorhydria	133
Hiatus Hernia	112
Gastritis Prophylaxis	106
Antacid Therapy	83
Gastrointestinal Disorder	77
Peptic Ulcer	75
Nausea	73
Reflux Oesophagitis	62
Duodenal Ulcer	61
Abdominal Pain	49
Rheumatoid Arthritis	46
Flatulence	45
Oesophagitis	43
Stomach Discomfort	40
Pain	38
Vomiting	38
Barretts Oesophagus	35
Urticaria	33
Gastric Ph Decreased	30
Chemotherapy	29
Hypersensitivity	29
Crohns Disease	26
Prophylaxis Of Nausea And Vomiting	24
Nervousness	22
Reflux Gastritis	21
Chest Pain	19
Hernia	19
Acne	18
Pruritus	17
Drug Exposure During Pregnancy	17
Gastrointestinal Disorder Therapy	17
Irritable Bowel Syndrome	16
Constipation	16
Gastrooesophageal Reflux Prophylaxi...	16
Breast Cancer	16
Pancreatitis	15
Duodenitis	14

Drug Labels

Label	Labeler	Effective
Zantac	GlaxoSmithKline LLC	18-JAN-11
Zantacefferdose	GlaxoSmithKline LLC	18-JAN-11
Zantac	GlaxoSmithKline LLC	04-MAY-11
Zantac	GlaxoSmithKline LLC	04-MAY-11
Zantac 75	Boehringer Ingelheim Pharmaceuticals Inc.	27-APR-12
Zantac Maximum Strength 150 Cool Mint	Boehringer Ingelheim Pharmaceuticals Inc.	27-APR-12
Maximum Strength Zantac	Boehringer Ingelheim Pharmaceuticals Inc.	27-APR-12
Zantac	Cardinal Health	02-AUG-12
Zantac	Covis Pharmaceuticals, Inc.	15-MAR-13
Zantac	Covis Pharmaceuticals, Inc.	15-MAR-13

Zantac Case Reports

What Zantac safety concerns are being reported by doctors and researchers in the medical literature?

About Results

This report contains aggregated drug side effects and adverse events for Zantac. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

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