NITROFURANTOIN

Nitrofurantoin Adverse Events Reported to the FDA Over Time

How are Nitrofurantoin adverse event reports trending over time?

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

Most Common Nitrofurantoin Adverse Events Reported to the FDA

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

Nausea	120 (2.44%)
Dyspnoea	102 (2.08%)
Pyrexia	94 (1.91%)
Chills	89 (1.81%)
Vomiting	85 (1.73%)
Headache	81 (1.65%)
Rash	67 (1.36%)
Asthenia	66 (1.34%)
Malaise	64 (1.3%)
Dizziness	56 (1.14%)
Fatigue	55 (1.12%)
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Chest Pain	51 (1.04%)
Diarrhoea	51 (1.04%)
Cough	50 (1.02%)
Urinary Tract Infection	47 (.96%)
Pain	44 (.9%)
Pruritus	44 (.9%)
Arthralgia	43 (.88%)
Pneumonia	39 (.79%)
Oedema Peripheral	37 (.75%)
Paraesthesia	37 (.75%)
Interstitial Lung Disease	36 (.73%)
Pulmonary Fibrosis	33 (.67%)
Hepatitis	32 (.65%)
Abdominal Pain	31 (.63%)
Abdominal Pain Upper	31 (.63%)
Drug Hypersensitivity	31 (.63%)
Myalgia	31 (.63%)
Tremor	31 (.63%)
Autoimmune Hepatitis	30 (.61%)
Drug Interaction	30 (.61%)
Weight Decreased	30 (.61%)
Urticaria	29 (.59%)
Loss Of Consciousness	26 (.53%)
Blood Pressure Increased	24 (.49%)
Dehydration	24 (.49%)
Jaundice	23 (.47%)
Somnolence	23 (.47%)
Back Pain	22 (.45%)
Burning Sensation	22 (.45%)
Confusional State	22 (.45%)
Drug Exposure During Pregnancy	22 (.45%)
Pain In Extremity	22 (.45%)
Drug Ineffective	21 (.43%)
Systemic Inflammatory Response Synd...	21 (.43%)
Feeling Abnormal	20 (.41%)
Hypoaesthesia	20 (.41%)
Intracranial Pressure Increased	20 (.41%)
Pulmonary Toxicity	20 (.41%)
Decreased Appetite	19 (.39%)
Hyperhidrosis	19 (.39%)
Hypotension	19 (.39%)
Neuropathy Peripheral	19 (.39%)
Swelling Face	19 (.39%)
Alanine Aminotransferase Increased	18 (.37%)
Optic Disc Disorder	18 (.37%)
Erythema	17 (.35%)
Liver Injury	17 (.35%)
Pneumonitis	17 (.35%)
Aspartate Aminotransferase Increase...	16 (.33%)
Cataract	16 (.33%)
Chest Discomfort	16 (.33%)
Condition Aggravated	16 (.33%)
Constipation	16 (.33%)
Lung Disorder	16 (.33%)
Hypersensitivity	15 (.31%)
Infection	15 (.31%)
Tubulointerstitial Nephritis	15 (.31%)
Visual Acuity Reduced	15 (.31%)
Fall	14 (.29%)
Pleural Effusion	14 (.29%)
Dry Mouth	13 (.26%)
Dysuria	13 (.26%)
Gait Disturbance	13 (.26%)
Hepatic Enzyme Increased	13 (.26%)
Hepatotoxicity	13 (.26%)
Influenza Like Illness	13 (.26%)
Insomnia	13 (.26%)
International Normalised Ratio Incr...	13 (.26%)
Leukocytosis	13 (.26%)
Liver Disorder	13 (.26%)
Lung Infiltration	13 (.26%)
Maternal Drugs Affecting Foetus	13 (.26%)
Respiratory Disorder	13 (.26%)
Abasia	12 (.24%)
Anxiety	12 (.24%)
Cleft Palate	12 (.24%)
Heart Rate Increased	12 (.24%)
Hypoxia	12 (.24%)
Muscle Spasms	12 (.24%)
Anorexia	11 (.22%)
Chromaturia	11 (.22%)
Convulsion	11 (.22%)
Craniosynostosis	11 (.22%)
Cystitis	11 (.22%)
Developmental Delay	11 (.22%)
Dyspepsia	11 (.22%)
Glaucoma	11 (.22%)
Hepatic Failure	11 (.22%)
Palpitations	11 (.22%)
Pierre Robin Syndrome	11 (.22%)

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

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

Gastrointestinal Signs	330 (6.72%)
Neurological	289 (5.88%)
Respiratory	282 (5.74%)
Epidermal And Dermal Conditions	247 (5.03%)
Hepatic And Hepatobiliary	235 (4.78%)
Infections - Pathogen Unspecified	168 (3.42%)
Lower Respiratory Tract Disorders	155 (3.16%)
Body Temperature Conditions	95 (1.93%)
Headaches	84 (1.71%)
Gastrointestinal Motility And Defec...	80 (1.63%)
Therapeutic And Nontherapeutic Effe...	79 (1.61%)
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Hepatobiliary	78 (1.59%)
Urinary Tract Signs	67 (1.36%)
Muscle	66 (1.34%)
Musculoskeletal And Connective Tiss...	66 (1.34%)
Allergic Conditions	59 (1.2%)
Joint	57 (1.16%)
Cardiac And Vascular Investigations	55 (1.12%)
Chemical Injury And Poisoning	52 (1.06%)
Movement Disorders	51 (1.04%)
Physical Examination Topics	43 (.88%)
Electrolyte And Fluid Balance Condi...	42 (.86%)
Vision	42 (.86%)
Injuries	41 (.83%)
Hematology Investigations	37 (.75%)
White Blood Cell	37 (.75%)
Peripheral Neuropathies	36 (.73%)
Renal And Urinary Tract Investigati...	35 (.71%)
Angiedema And Urticaria	34 (.69%)
Musculoskeletal And Connective Tiss...	34 (.69%)
Appetite And General Nutritional	33 (.67%)
Medication Errors	33 (.67%)
Deliria	32 (.65%)
Anxiety Disorders	31 (.63%)
Cardiac Arrhythmias	31 (.63%)
Bronchial Disorders	28 (.57%)
Skin Appendage Conditions	28 (.57%)
Decreased And Nonspecific Blood Pre...	25 (.51%)
Renal Disorders	25 (.51%)
Sleep Disorders	25 (.51%)
Increased Intracranial Pressure And...	23 (.47%)
Bacterial Infectious	22 (.45%)
Ocular Structural Change, Deposit A...	22 (.45%)
Cardiac Disorder Signs	21 (.43%)
Enzyme	20 (.41%)
Oral Soft Tissue Conditions	20 (.41%)
Seizures	20 (.41%)
Viral Infectious	20 (.41%)
Eye	19 (.39%)
Gastrointestinal Tract Disorders Co...	19 (.39%)
Metabolic, Nutritional And Blood Ga...	19 (.39%)
Pleural	19 (.39%)
Salivary Gland Conditions	19 (.39%)
Skin Vascular Abnormalities	19 (.39%)
Mental Impairment	17 (.35%)
Nephropathies	17 (.35%)
Tongue Conditions	17 (.35%)
Anterior Eye Structural Change, Dep...	16 (.33%)
Ocular Infections, Irritations And ...	16 (.33%)
Anemias Nonhemolytic And Marrow Dep...	14 (.29%)
Eye Disorders Congenital	14 (.29%)
Lifestyle Issues	14 (.29%)
Microbiology And Serology	14 (.29%)
Upper Respiratory Tract Disorders	14 (.29%)
Bone And Joint Injuries	13 (.26%)
Bone Disorders	13 (.26%)
Platelet	13 (.26%)
Central Nervous System Vascular	12 (.24%)
Neonatal And Perinatal Conditions	12 (.24%)
Pulmonary Vascular	12 (.24%)
Vascular	12 (.24%)
Water, Electrolyte And Mineral	12 (.24%)
Depressed Mood Disorders	11 (.22%)
Embolism And Thrombosis	11 (.22%)
Fungal Infectious	11 (.22%)
Gastrointestinal Conditions	11 (.22%)
Glaucoma And Ocular Hypertension	11 (.22%)
Glucose Metabolism Disorders	11 (.22%)
Hepatobiliary Therapeutic Procedure...	11 (.22%)
Immunology And Allergy	11 (.22%)
Product Quality Issues	11 (.22%)
Somatoform And Factitious	11 (.22%)
Coagulopathies And Bleeding Diathes...	10 (.2%)
Hearing	10 (.2%)
Obstetric And Gynecological Therape...	10 (.2%)
Psychiatric	10 (.2%)
Procedural And Device Related Injur...	9 (.18%)
Acid-base	8 (.16%)
Arteriosclerosis, Stenosis, Vascula...	8 (.16%)
Encephalopathies	8 (.16%)
Heart Failures	8 (.16%)
Maternal Complications Of Pregnancy	8 (.16%)
Peritoneal And Retroperitoneal Cond...	8 (.16%)
Pregnancy, Labour, Delivery And Pos...	8 (.16%)
Cardiac And Vascular Disorders Cong...	7 (.14%)
Cranial Nerve Disorders	7 (.14%)
Exocrine Pancreas Conditions	7 (.14%)
Gastrointestinal Hemorrhages	7 (.14%)
Abortions And Stillbirth	6 (.12%)
Bladder And Bladder Neck Disorders	6 (.12%)
Gallbladder	6 (.12%)

Share/Embed Graph Export Data

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