AZITHROMYCIN

Azithromycin Adverse Events Reported to the FDA Over Time

How are Azithromycin adverse event reports trending over time?

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

Most Common Azithromycin Adverse Events Reported to the FDA

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

Diarrhoea	485 (1.82%)
Nausea	401 (1.5%)
Drug Ineffective	375 (1.41%)
Vomiting	369 (1.38%)
Dyspnoea	330 (1.24%)
Pyrexia	325 (1.22%)
Rash	314 (1.18%)
Drug Interaction	247 (.93%)
Hypersensitivity	234 (.88%)
Headache	222 (.83%)
Dizziness	220 (.82%)
	Show More
Urticaria	218 (.82%)
Abdominal Pain	215 (.81%)
Pruritus	198 (.74%)
Drug Hypersensitivity	197 (.74%)
Malaise	194 (.73%)
Abdominal Pain Upper	192 (.72%)
Pneumonia	187 (.7%)
Asthenia	176 (.66%)
Weight Decreased	166 (.62%)
Cough	165 (.62%)
Condition Aggravated	150 (.56%)
Fatigue	145 (.54%)
Loss Of Consciousness	145 (.54%)
Stevens-johnson Syndrome	145 (.54%)
Pain	142 (.53%)
Tinnitus	138 (.52%)
Anxiety	137 (.51%)
Rhabdomyolysis	130 (.49%)
Deafness	128 (.48%)
Insomnia	122 (.46%)
Feeling Abnormal	119 (.45%)
Chest Pain	118 (.44%)
Erythema	118 (.44%)
Hypotension	117 (.44%)
Oedema Peripheral	113 (.42%)
Ageusia	108 (.4%)
Anosmia	108 (.4%)
Dehydration	107 (.4%)
Alanine Aminotransferase Increased	103 (.39%)
Aspartate Aminotransferase Increase...	101 (.38%)
Cardiac Arrest	95 (.36%)
Chills	95 (.36%)
Renal Failure Acute	94 (.35%)
Tachycardia	94 (.35%)
Electrocardiogram Qt Prolonged	93 (.35%)
Bronchitis	92 (.34%)
Dysphagia	92 (.34%)
Tremor	91 (.34%)
Medication Error	89 (.33%)
Convulsion	87 (.33%)
Palpitations	87 (.33%)
Arthralgia	85 (.32%)
Nasopharyngitis	82 (.31%)
Decreased Appetite	81 (.3%)
International Normalised Ratio Incr...	79 (.3%)
Abdominal Discomfort	78 (.29%)
Dysgeusia	74 (.28%)
Sinusitis	74 (.28%)
Swelling Face	74 (.28%)
Drug Eruption	72 (.27%)
Liver Disorder	72 (.27%)
Myalgia	72 (.27%)
Pain In Extremity	72 (.27%)
Confusional State	71 (.27%)
Asthma	70 (.26%)
Heart Rate Increased	70 (.26%)
Swelling	70 (.26%)
Death	69 (.26%)
Somnolence	67 (.25%)
Constipation	66 (.25%)
Hypoaesthesia	66 (.25%)
Back Pain	65 (.24%)
C-reactive Protein Increased	65 (.24%)
Renal Failure	65 (.24%)
Anaemia	64 (.24%)
Drug Exposure During Pregnancy	64 (.24%)
Syncope	64 (.24%)
Pancytopenia	63 (.24%)
Blood Pressure Increased	61 (.23%)
Product Quality Issue	61 (.23%)
Sepsis	61 (.23%)
Depression	60 (.22%)
Rash Generalised	60 (.22%)
Hepatic Function Abnormal	59 (.22%)
Hyperhidrosis	59 (.22%)
Blister	57 (.21%)
Blood Pressure Decreased	56 (.21%)
Pallor	56 (.21%)
Viral Infection	56 (.21%)
Anaphylactic Shock	55 (.21%)
Blood Alkaline Phosphatase Increase...	55 (.21%)
Chromaturia	55 (.21%)
Shock	55 (.21%)
Delirium	54 (.2%)
Jaundice	54 (.2%)
No Adverse Event	54 (.2%)
Paraesthesia	54 (.2%)
Vision Blurred	54 (.2%)
Haematochezia	52 (.19%)
Interstitial Lung Disease	52 (.19%)

Share/Embed Graph Export Data

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

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

Epidermal And Dermal Conditions	1626 (6.1%)
Gastrointestinal Signs	1578 (5.92%)
Neurological	1251 (4.69%)
Respiratory	1081 (4.05%)
Infections - Pathogen Unspecified	987 (3.7%)
Therapeutic And Nontherapeutic Effe...	745 (2.79%)
Gastrointestinal Motility And Defec...	634 (2.38%)
Cardiac Arrhythmias	601 (2.25%)
Allergic Conditions	577 (2.16%)
Hepatic And Hepatobiliary	573 (2.15%)
Hematology Investigations	446 (1.67%)
	Show More
Cardiac And Vascular Investigations	427 (1.6%)
Medication Errors	424 (1.59%)
Hepatobiliary	417 (1.56%)
Body Temperature Conditions	363 (1.36%)
Muscle	333 (1.25%)
Bacterial Infectious	308 (1.15%)
Anxiety Disorders	275 (1.03%)
Renal Disorders	269 (1.01%)
Hearing	260 (.97%)
Headaches	257 (.96%)
Injuries	257 (.96%)
Physical Examination Topics	252 (.94%)
Angiedema And Urticaria	247 (.93%)
Viral Infectious	247 (.93%)
Oral Soft Tissue Conditions	245 (.92%)
Musculoskeletal And Connective Tiss...	237 (.89%)
Decreased And Nonspecific Blood Pre...	234 (.88%)
Electrolyte And Fluid Balance Condi...	223 (.84%)
Upper Respiratory Tract Disorders	213 (.8%)
Urinary Tract Signs	209 (.78%)
Joint	203 (.76%)
Movement Disorders	202 (.76%)
Sleep Disorders	199 (.75%)
Ocular Infections, Irritations And ...	196 (.73%)
Anemias Nonhemolytic And Marrow Dep...	195 (.73%)
Lower Respiratory Tract Disorders	187 (.7%)
Inner Ear And Viiith Cranial Nerve	183 (.69%)
Vision	181 (.68%)
Skin Appendage Conditions	172 (.64%)
Bronchial Disorders	170 (.64%)
Cranial Nerve Disorders	166 (.62%)
Appetite And General Nutritional	162 (.61%)
Eye	161 (.6%)
White Blood Cell	158 (.59%)
Cardiac Disorder Signs	152 (.57%)
Seizures	152 (.57%)
Gastrointestinal Hemorrhages	150 (.56%)
Deliria	147 (.55%)
Enzyme	135 (.51%)
Administration Site Reactions	133 (.5%)
Fungal Infectious	133 (.5%)
Product Quality Issues	133 (.5%)
Tongue Conditions	131 (.49%)
Disturbances In Thinking	128 (.48%)
Vascular	126 (.47%)
Metabolic, Nutritional And Blood Ga...	119 (.45%)
Chemical Injury And Poisoning	116 (.43%)
Gastrointestinal Inflammatory Condi...	115 (.43%)
Lifestyle Issues	109 (.41%)
Renal And Urinary Tract Investigati...	109 (.41%)
Fatal Outcomes	104 (.39%)
Protein And Chemistry Analyses	97 (.36%)
Water, Electrolyte And Mineral	96 (.36%)
Mental Impairment	92 (.34%)
Gastrointestinal Conditions	86 (.32%)
Aural	83 (.31%)
Depressed Mood Disorders	80 (.3%)
Skin Vascular Abnormalities	77 (.29%)
Platelet	73 (.27%)
Spleen, Lymphatic And Reticulendoth...	72 (.27%)
Coronary Artery	71 (.27%)
Exocrine Pancreas Conditions	66 (.25%)
Coagulopathies And Bleeding Diathes...	62 (.23%)
Heart Failures	62 (.23%)
Salivary Gland Conditions	60 (.22%)
Toxicology And Therapeutic Drug Mon...	60 (.22%)
Personality Disorders	59 (.22%)
Mood Disorders	58 (.22%)
Encephalopathies	57 (.21%)
Therapeutic Procedures And Supporti...	57 (.21%)
Psychiatric	56 (.21%)
Glucose Metabolism Disorders	54 (.2%)
Myocardial	54 (.2%)
Lipid Analyses	53 (.2%)
Vascular Hemorrhagic	52 (.19%)
Dental And Gingival Conditions	51 (.19%)
Hemolyses And Related Conditions	51 (.19%)
Pleural	50 (.19%)
Psychiatric And Behavioural Symptom...	48 (.18%)
Bone Disorders	44 (.16%)
Gastrointestinal Ulceration And Per...	43 (.16%)
Glaucoma And Ocular Hypertension	43 (.16%)
Musculoskeletal And Connective Tiss...	42 (.16%)
Microbiology And Serology	41 (.15%)
Procedural And Device Related Injur...	41 (.15%)
Bone And Joint Injuries	40 (.15%)
Somatoform And Factitious	40 (.15%)
Eating Disorders	37 (.14%)
Mycobacterial Infectious	37 (.14%)
Central Nervous System Vascular	36 (.13%)

Share/Embed Graph Export Data

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