CEPHALEXIN

Cephalexin Adverse Events Reported to the FDA Over Time

How are Cephalexin adverse event reports trending over time?

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

Most Common Cephalexin Adverse Events Reported to the FDA

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

Rash	117 (1.76%)
Diarrhoea	115 (1.73%)
Pyrexia	100 (1.5%)
Drug Hypersensitivity	93 (1.4%)
Drug Interaction	91 (1.37%)
Nausea	91 (1.37%)
Vomiting	91 (1.37%)
Dyspnoea	83 (1.25%)
Pruritus	83 (1.25%)
Urticaria	76 (1.14%)
Abdominal Pain	68 (1.02%)
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Pain	63 (.95%)
International Normalised Ratio Incr...	62 (.93%)
Dizziness	58 (.87%)
Malaise	56 (.84%)
Arthralgia	55 (.83%)
Drug Ineffective	55 (.83%)
Headache	55 (.83%)
White Blood Cell Count Increased	47 (.71%)
Deep Vein Thrombosis	46 (.69%)
Stevens-johnson Syndrome	46 (.69%)
Haemoglobin Decreased	45 (.68%)
Pain In Extremity	43 (.65%)
Hypovolaemic Shock	42 (.63%)
Retroperitoneal Haematoma	42 (.63%)
Fatigue	41 (.62%)
Renal Failure Acute	41 (.62%)
Abdominal Pain Upper	38 (.57%)
Hypersensitivity	38 (.57%)
Ureteric Obstruction	38 (.57%)
Urinary Tract Infection	38 (.57%)
Drug Exposure During Pregnancy	36 (.54%)
Anaemia	33 (.5%)
Chest Pain	33 (.5%)
Erythema	33 (.5%)
Completed Suicide	32 (.48%)
Dehydration	32 (.48%)
Muscle Haemorrhage	32 (.48%)
Oedema Peripheral	31 (.47%)
Medication Error	28 (.42%)
Anaphylactic Reaction	27 (.41%)
Rash Pruritic	27 (.41%)
Cellulitis	26 (.39%)
Myalgia	26 (.39%)
Rash Erythematous	26 (.39%)
Rash Generalised	26 (.39%)
Blister	25 (.38%)
Hypotension	25 (.38%)
Swelling Face	25 (.38%)
Condition Aggravated	24 (.36%)
Skin Exfoliation	24 (.36%)
Asthenia	23 (.35%)
Hyponatraemia	23 (.35%)
Muscle Spasms	23 (.35%)
Chills	22 (.33%)
Loss Of Consciousness	22 (.33%)
Paraesthesia	22 (.33%)
Swollen Tongue	22 (.33%)
Decreased Appetite	21 (.32%)
Liver Disorder	21 (.32%)
Liver Function Test Abnormal	21 (.32%)
Weight Decreased	21 (.32%)
Clostridium Difficile Colitis	20 (.3%)
Constipation	20 (.3%)
Tremor	20 (.3%)
Blood Pressure Increased	19 (.29%)
Convulsion	19 (.29%)
Muscular Weakness	19 (.29%)
Pruritus Generalised	19 (.29%)
Staphylococcal Infection	19 (.29%)
Alanine Aminotransferase Increased	18 (.27%)
Heart Rate Increased	18 (.27%)
Clostridial Infection	17 (.26%)
Erythema Multiforme	17 (.26%)
Insomnia	17 (.26%)
Toxic Epidermal Necrolysis	17 (.26%)
Acute Generalised Exanthematous Pus...	16 (.24%)
Cough	16 (.24%)
Cystitis	16 (.24%)
Extrasystoles	16 (.24%)
Haematuria	16 (.24%)
Infection	16 (.24%)
Sinusitis	16 (.24%)
Swelling	16 (.24%)
Fall	15 (.23%)
Feeling Abnormal	15 (.23%)
Hip Fracture	15 (.23%)
Rash Macular	15 (.23%)
Rhabdomyolysis	15 (.23%)
Somnolence	15 (.23%)
Angioedema	14 (.21%)
Apnoea	14 (.21%)
Chest Discomfort	14 (.21%)
Confusional State	14 (.21%)
Drug Dispensing Error	14 (.21%)
Dysphagia	14 (.21%)
Dysuria	14 (.21%)
Rash Papular	14 (.21%)
Anxiety	13 (.2%)
Blood Creatinine Increased	13 (.2%)
Cardiac Arrest	13 (.2%)

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

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

Epidermal And Dermal Conditions	670 (10.06%)
Gastrointestinal Signs	361 (5.42%)
Infections - Pathogen Unspecified	276 (4.15%)
Neurological	228 (3.42%)
Respiratory	213 (3.2%)
Therapeutic And Nontherapeutic Effe...	202 (3.03%)
Hematology Investigations	184 (2.76%)
Allergic Conditions	174 (2.61%)
Gastrointestinal Motility And Defec...	148 (2.22%)
Muscle	124 (1.86%)
Bacterial Infectious	122 (1.83%)
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Hepatic And Hepatobiliary	107 (1.61%)
Body Temperature Conditions	103 (1.55%)
Medication Errors	98 (1.47%)
Joint	95 (1.43%)
Angiedema And Urticaria	90 (1.35%)
Electrolyte And Fluid Balance Condi...	87 (1.31%)
Decreased And Nonspecific Blood Pre...	78 (1.17%)
Renal Disorders	73 (1.1%)
Musculoskeletal And Connective Tiss...	72 (1.08%)
Oral Soft Tissue Conditions	71 (1.07%)
Cardiac And Vascular Investigations	70 (1.05%)
Cardiac Arrhythmias	70 (1.05%)
Hepatobiliary	69 (1.04%)
Chemical Injury And Poisoning	65 (.98%)
Injuries	63 (.95%)
Renal And Urinary Tract Investigati...	59 (.89%)
Headaches	57 (.86%)
Movement Disorders	55 (.83%)
Upper Respiratory Tract Disorders	55 (.83%)
Urinary Tract Signs	54 (.81%)
Embolism And Thrombosis	51 (.77%)
Suicidal And Self-injurious Behavio...	50 (.75%)
Anemias Nonhemolytic And Marrow Dep...	48 (.72%)
Peritoneal And Retroperitoneal Cond...	47 (.71%)
Physical Examination Topics	43 (.65%)
Ureteric	41 (.62%)
Bone And Joint Injuries	38 (.57%)
Viral Infectious	38 (.57%)
Psychiatric	36 (.54%)
Skin Vascular Abnormalities	36 (.54%)
Sleep Disorders	36 (.54%)
Mood Disorders	35 (.53%)
White Blood Cell	33 (.5%)
Lifestyle Issues	32 (.48%)
Tongue Conditions	32 (.48%)
Anxiety Disorders	31 (.47%)
Appetite And General Nutritional	30 (.45%)
Skin Appendage Conditions	29 (.44%)
Deliria	27 (.41%)
Myocardial	27 (.41%)
Vision	27 (.41%)
Seizures	26 (.39%)
Gastrointestinal Hemorrhages	25 (.38%)
Dental And Gingival Conditions	24 (.36%)
Gallbladder	24 (.36%)
Product Quality Issues	24 (.36%)
Nephropathies	23 (.35%)
Cardiac Disorder Signs	22 (.33%)
Mental Impairment	21 (.32%)
Metabolic, Nutritional And Blood Ga...	21 (.32%)
Procedural And Device Related Injur...	21 (.32%)
Enzyme	20 (.3%)
Eye	20 (.3%)
Fungal Infectious	20 (.3%)
Ocular Infections, Irritations And ...	19 (.29%)
Water, Electrolyte And Mineral	19 (.29%)
Administration Site Reactions	18 (.27%)
Gastrointestinal Conditions	17 (.26%)
Gastrointestinal Inflammatory Condi...	17 (.26%)
Hematological And Lymphoid Tissue T...	17 (.26%)
Spleen, Lymphatic And Reticulendoth...	17 (.26%)
Vascular	17 (.26%)
Breast	15 (.23%)
Bronchial Disorders	15 (.23%)
Hematological	15 (.23%)
Lower Respiratory Tract Disorders	15 (.23%)
Personality Disorders	15 (.23%)
Tissue	15 (.23%)
Vulvovaginal Disorders	15 (.23%)
Red Blood Cell	14 (.21%)
Bone Disorders	13 (.2%)
Coagulopathies And Bleeding Diathes...	13 (.2%)
Depressed Mood Disorders	13 (.2%)
Microbiology And Serology	13 (.2%)
Vascular Hypertensive	13 (.2%)
Abortions And Stillbirth	12 (.18%)
Bone, Calcium, Magnesium And Phosph...	12 (.18%)
Hemolyses And Related Conditions	12 (.18%)
Neurological Disorders Congenital	12 (.18%)
Protein And Chemistry Analyses	12 (.18%)
Renal And Urinary Tract Disorders C...	12 (.18%)
Sexual Dysfunctions, Disturbances A...	12 (.18%)
Sexual Function And Fertility	12 (.18%)
Acid-base	11 (.17%)
Cardiac Valve	11 (.17%)
Inner Ear And Viiith Cranial Nerve	11 (.17%)
Neonatal Respiratory	11 (.17%)
Ocular Neuromuscular	11 (.17%)
Sleep Disturbances	11 (.17%)
Vascular Hemorrhagic	11 (.17%)

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