AMLODIPINE

Amlodipine Adverse Events Reported to the FDA Over Time

How are Amlodipine adverse event reports trending over time?

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

Most Common Amlodipine Adverse Events Reported to the FDA

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

Oedema Peripheral	1212 (1.78%)
Dizziness	1107 (1.62%)
Hypotension	1064 (1.56%)
Blood Pressure Increased	817 (1.2%)
Drug Ineffective	801 (1.17%)
Hypertension	761 (1.11%)
Completed Suicide	758 (1.11%)
Headache	729 (1.07%)
Dyspnoea	631 (.92%)
Death	616 (.9%)
Nausea	578 (.85%)
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Drug Interaction	570 (.84%)
Fatigue	558 (.82%)
Malaise	549 (.8%)
Blood Pressure Inadequately Control...	498 (.73%)
Renal Failure Acute	498 (.73%)
Overdose	474 (.69%)
Fall	432 (.63%)
Loss Of Consciousness	431 (.63%)
Asthenia	396 (.58%)
Rash	372 (.54%)
Vomiting	369 (.54%)
Blood Pressure Decreased	359 (.53%)
Syncope	355 (.52%)
Pain In Extremity	352 (.52%)
Bradycardia	348 (.51%)
Suicide Attempt	342 (.5%)
Cerebrovascular Accident	330 (.48%)
Joint Swelling	329 (.48%)
Chest Pain	328 (.48%)
Renal Failure	327 (.48%)
Cough	325 (.48%)
Feeling Abnormal	317 (.46%)
Palpitations	312 (.46%)
Diarrhoea	310 (.45%)
Pruritus	300 (.44%)
Pyrexia	297 (.44%)
Weight Decreased	290 (.42%)
Insomnia	286 (.42%)
Arthralgia	284 (.42%)
Somnolence	279 (.41%)
Pain	262 (.38%)
Condition Aggravated	260 (.38%)
Pneumonia	257 (.38%)
Myalgia	256 (.38%)
Intentional Overdose	254 (.37%)
Muscle Spasms	247 (.36%)
Metabolic Acidosis	238 (.35%)
Myocardial Infarction	236 (.35%)
Oedema	233 (.34%)
Cardiac Arrest	232 (.34%)
Heart Rate Increased	226 (.33%)
Hyperkalaemia	221 (.32%)
Abdominal Pain	214 (.31%)
Blood Creatinine Increased	214 (.31%)
Hyponatraemia	212 (.31%)
Hypersensitivity	209 (.31%)
Pulmonary Oedema	206 (.3%)
Dehydration	203 (.3%)
Gait Disturbance	203 (.3%)
Anaemia	199 (.29%)
Muscular Weakness	199 (.29%)
Renal Impairment	199 (.29%)
Constipation	197 (.29%)
Dry Mouth	195 (.29%)
Weight Increased	194 (.28%)
Blood Glucose Increased	192 (.28%)
Hypokalaemia	192 (.28%)
Rhabdomyolysis	189 (.28%)
Back Pain	186 (.27%)
Confusional State	185 (.27%)
Alanine Aminotransferase Increased	184 (.27%)
Depression	184 (.27%)
Respiratory Failure	184 (.27%)
Swelling	184 (.27%)
Vision Blurred	184 (.27%)
Tremor	183 (.27%)
Blood Creatine Phosphokinase Increa...	173 (.25%)
Aspartate Aminotransferase Increase...	171 (.25%)
Shock	171 (.25%)
Decreased Appetite	169 (.25%)
Angioedema	168 (.25%)
Drug Toxicity	166 (.24%)
Abdominal Pain Upper	165 (.24%)
Atrial Fibrillation	165 (.24%)
Depressed Level Of Consciousness	164 (.24%)
Cardiac Failure Congestive	161 (.24%)
Drug Hypersensitivity	161 (.24%)
Diabetes Mellitus	160 (.23%)
Interstitial Lung Disease	159 (.23%)
Cardiac Failure	156 (.23%)
Blood Cholesterol Increased	155 (.23%)
Paraesthesia	155 (.23%)
Anxiety	152 (.22%)
Asthma	152 (.22%)
Erythema	149 (.22%)
Convulsion	148 (.22%)
Haemoglobin Decreased	148 (.22%)
Tachycardia	148 (.22%)
Multiple Drug Overdose	143 (.21%)
Hepatic Function Abnormal	141 (.21%)

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

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

Neurological	3790 (5.55%)
Epidermal And Dermal Conditions	2651 (3.88%)
Respiratory	2301 (3.37%)
Cardiac And Vascular Investigations	2282 (3.34%)
Decreased And Nonspecific Blood Pre...	2111 (3.09%)
Cardiac Arrhythmias	1980 (2.9%)
Gastrointestinal Signs	1972 (2.89%)
Therapeutic And Nontherapeutic Effe...	1763 (2.58%)
Medication Errors	1604 (2.35%)
Renal Disorders	1511 (2.21%)
Infections - Pathogen Unspecified	1210 (1.77%)
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Suicidal And Self-injurious Behavio...	1184 (1.73%)
Muscle	1112 (1.63%)
Electrolyte And Fluid Balance Condi...	1011 (1.48%)
Injuries	969 (1.42%)
Central Nervous System Vascular	911 (1.33%)
Musculoskeletal And Connective Tiss...	870 (1.27%)
Hepatic And Hepatobiliary	863 (1.26%)
Vascular Hypertensive	860 (1.26%)
Lower Respiratory Tract Disorders	857 (1.26%)
Hematology Investigations	840 (1.23%)
Joint	836 (1.22%)
Headaches	788 (1.15%)
Fatal Outcomes	692 (1.01%)
Gastrointestinal Motility And Defec...	684 (1%)
Hepatobiliary	682 (1%)
Physical Examination Topics	676 (.99%)
Urinary Tract Signs	646 (.95%)
Coronary Artery	623 (.91%)
Renal And Urinary Tract Investigati...	600 (.88%)
Cardiac Disorder Signs	560 (.82%)
Vision	539 (.79%)
Heart Failures	514 (.75%)
Movement Disorders	511 (.75%)
Glucose Metabolism Disorders	483 (.71%)
Metabolic, Nutritional And Blood Ga...	481 (.7%)
Allergic Conditions	479 (.7%)
Dental And Gingival Conditions	479 (.7%)
Anxiety Disorders	474 (.69%)
Sleep Disorders	466 (.68%)
Skin Appendage Conditions	438 (.64%)
Vascular	415 (.61%)
Anemias Nonhemolytic And Marrow Dep...	409 (.6%)
Chemical Injury And Poisoning	406 (.59%)
Appetite And General Nutritional	375 (.55%)
Water, Electrolyte And Mineral	363 (.53%)
Mental Impairment	351 (.51%)
Enzyme	349 (.51%)
Lifestyle Issues	347 (.51%)
Bone And Joint Injuries	341 (.5%)
Bronchial Disorders	334 (.49%)
Acid-base	331 (.48%)
Angiedema And Urticaria	330 (.48%)
Body Temperature Conditions	328 (.48%)
Oral Soft Tissue Conditions	324 (.47%)
Deliria	313 (.46%)
Upper Respiratory Tract Disorders	293 (.43%)
Arteriosclerosis, Stenosis, Vascula...	284 (.42%)
Bacterial Infectious	274 (.4%)
Depressed Mood Disorders	267 (.39%)
Lipid Analyses	264 (.39%)
Gastrointestinal Hemorrhages	257 (.38%)
Eye	248 (.36%)
Inner Ear And Viiith Cranial Nerve	248 (.36%)
White Blood Cell	239 (.35%)
Skin Vascular Abnormalities	232 (.34%)
Myocardial	222 (.33%)
Product Quality Issues	219 (.32%)
Nephropathies	218 (.32%)
Salivary Gland Conditions	208 (.3%)
Seizures	203 (.3%)
Viral Infectious	203 (.3%)
Psychiatric	198 (.29%)
Tongue Conditions	187 (.27%)
Gastrointestinal Inflammatory Condi...	175 (.26%)
Procedural And Device Related Injur...	172 (.25%)
Disturbances In Thinking	169 (.25%)
Therapeutic Procedures And Supporti...	169 (.25%)
Platelet	164 (.24%)
Peripheral Neuropathies	161 (.24%)
Hematological And Lymphoid Tissue T...	144 (.21%)
Protein And Chemistry Analyses	138 (.2%)
Bone Disorders	136 (.2%)
Pleural	135 (.2%)
Embolism And Thrombosis	134 (.2%)
Mood Disorders	126 (.18%)
Cardiac Valve	125 (.18%)
Anterior Eye Structural Change, Dep...	122 (.18%)
Hearing	119 (.17%)
Tissue	119 (.17%)
Toxicology And Therapeutic Drug Mon...	119 (.17%)
Coagulopathies And Bleeding Diathes...	118 (.17%)
Vascular Hemorrhagic	116 (.17%)
Exocrine Pancreas Conditions	112 (.16%)
Sexual Function And Fertility	111 (.16%)
Ocular Infections, Irritations And ...	102 (.15%)
Immunology And Allergy	101 (.15%)
Neuromuscular	100 (.15%)
Breast	98 (.14%)
Gastrointestinal Ulceration And Per...	98 (.14%)
Gallbladder	95 (.14%)

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