NICOTINE

Nicotine Adverse Events Reported to the FDA Over Time

How are Nicotine adverse event reports trending over time?

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

Most Common Nicotine Adverse Events Reported to the FDA

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

Intentional Drug Misuse	566 (3.58%)
Nicotine Dependence	546 (3.45%)
Nausea	396 (2.5%)
Drug Ineffective	316 (2%)
Dizziness	273 (1.72%)
Drug Administration Error	268 (1.69%)
Dyspnoea	245 (1.55%)
Overdose	238 (1.5%)
Treatment Noncompliance	233 (1.47%)
Malaise	210 (1.33%)
Headache	194 (1.23%)
	Show More
Incorrect Drug Administration Durat...	194 (1.23%)
Vomiting	178 (1.12%)
Anxiety	151 (.95%)
Product Quality Issue	143 (.9%)
Feeling Abnormal	135 (.85%)
Dependence	133 (.84%)
Drug Dependence	127 (.8%)
Chest Pain	126 (.8%)
Palpitations	117 (.74%)
Insomnia	112 (.71%)
Blood Pressure Increased	102 (.64%)
Depression	99 (.63%)
Tremor	98 (.62%)
Application Site Erythema	96 (.61%)
Abnormal Dreams	94 (.59%)
Oral Discomfort	92 (.58%)
Drug Toxicity	91 (.57%)
Irritability	90 (.57%)
Drug Interaction	88 (.56%)
Dyspepsia	88 (.56%)
Hallucination	88 (.56%)
Fatigue	87 (.55%)
Hypersensitivity	87 (.55%)
Loss Of Consciousness	86 (.54%)
Cough	81 (.51%)
Pruritus	79 (.5%)
Pain	78 (.49%)
Heart Rate Increased	77 (.49%)
Hypoaesthesia	76 (.48%)
Diarrhoea	75 (.47%)
Blood Glucose Increased	74 (.47%)
Asthenia	73 (.46%)
Condition Aggravated	72 (.45%)
Stomatitis	71 (.45%)
Convulsion	70 (.44%)
Dysgeusia	70 (.44%)
Wrong Technique In Drug Usage Proce...	70 (.44%)
Pain In Extremity	69 (.44%)
Hyperhidrosis	68 (.43%)
Abdominal Pain Upper	67 (.42%)
Application Site Pruritus	67 (.42%)
Hypertension	66 (.42%)
Nightmare	65 (.41%)
Stress	61 (.39%)
Rash	60 (.38%)
Throat Irritation	58 (.37%)
Myocardial Infarction	57 (.36%)
Glossodynia	56 (.35%)
Nervousness	56 (.35%)
Oropharyngeal Pain	55 (.35%)
Abdominal Discomfort	53 (.33%)
Oral Pain	53 (.33%)
Urticaria	53 (.33%)
Hiccups	52 (.33%)
Oedema Peripheral	52 (.33%)
Sleep Disorder	52 (.33%)
Incorrect Dose Administered	50 (.32%)
Weight Increased	50 (.32%)
Depressed Mood	49 (.31%)
Drug Withdrawal Syndrome	49 (.31%)
Inappropriate Schedule Of Drug Admi...	49 (.31%)
Anger	48 (.3%)
Expired Drug Administered	47 (.3%)
Somnolence	47 (.3%)
Withdrawal Syndrome	46 (.29%)
Pneumonia	45 (.28%)
Rash Erythematous	45 (.28%)
Suicidal Ideation	45 (.28%)
Flatulence	43 (.27%)
Asthma	42 (.27%)
Syncope	42 (.27%)
Confusional State	41 (.26%)
Fall	41 (.26%)
Pharyngeal Oedema	41 (.26%)
Blister	40 (.25%)
Ischaemic Stroke	40 (.25%)
Burning Sensation	39 (.25%)
Crying	39 (.25%)
Homicidal Ideation	39 (.25%)
Retching	39 (.25%)
Erythema	38 (.24%)
Drug Exposure During Pregnancy	37 (.23%)
Dry Mouth	35 (.22%)
Vision Blurred	35 (.22%)
Angina Pectoris	34 (.21%)
Blood Pressure Decreased	34 (.21%)
Pyrexia	34 (.21%)
Chest Discomfort	33 (.21%)
Chronic Obstructive Pulmonary Disea...	33 (.21%)
Pruritus Generalised	33 (.21%)

Share/Embed Graph Export Data

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

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

Psychiatric	1519 (9.6%)
Medication Errors	1077 (6.8%)
Gastrointestinal Signs	970 (6.13%)
Neurological	876 (5.53%)
Respiratory	722 (4.56%)
Epidermal And Dermal Conditions	611 (3.86%)
Therapeutic And Nontherapeutic Effe...	536 (3.39%)
Administration Site Reactions	423 (2.67%)
Oral Soft Tissue Conditions	407 (2.57%)
Anxiety Disorders	374 (2.36%)
Sleep Disorders	339 (2.14%)
	Show More
Lifestyle Issues	314 (1.98%)
Cardiac And Vascular Investigations	267 (1.69%)
Headaches	214 (1.35%)
Infections - Pathogen Unspecified	202 (1.28%)
Dental And Gingival Conditions	187 (1.18%)
Chemical Injury And Poisoning	186 (1.18%)
Cardiac Disorder Signs	166 (1.05%)
Depressed Mood Disorders	162 (1.02%)
Musculoskeletal And Connective Tiss...	161 (1.02%)
Injuries	159 (1%)
Product Quality Issues	157 (.99%)
Disturbances In Thinking	152 (.96%)
Movement Disorders	148 (.94%)
Allergic Conditions	147 (.93%)
Tongue Conditions	143 (.9%)
Mood Disorders	140 (.88%)
Central Nervous System Vascular	131 (.83%)
Coronary Artery	127 (.8%)
Gastrointestinal Motility And Defec...	127 (.8%)
Skin Appendage Conditions	114 (.72%)
Seizures	103 (.65%)
Bronchial Disorders	99 (.63%)
Cardiac Arrhythmias	99 (.63%)
Metabolic, Nutritional And Blood Ga...	90 (.57%)
Upper Respiratory Tract Disorders	90 (.57%)
Vision	87 (.55%)
Deliria	83 (.52%)
Personality Disorders	79 (.5%)
Suicidal And Self-injurious Behavio...	75 (.47%)
Vascular Hypertensive	72 (.45%)
Physical Examination Topics	69 (.44%)
Angiedema And Urticaria	68 (.43%)
Muscle	67 (.42%)
Lower Respiratory Tract Disorders	66 (.42%)
Mental Impairment	66 (.42%)
Vascular	61 (.39%)
Joint	60 (.38%)
Salivary Gland Conditions	59 (.37%)
Decreased And Nonspecific Blood Pre...	51 (.32%)
Appetite And General Nutritional	44 (.28%)
Injuries By Physical Agents	44 (.28%)
Bone And Joint Injuries	42 (.27%)
Bone Disorders	41 (.26%)
Gastrointestinal Conditions	41 (.26%)
Hematology Investigations	39 (.25%)
Body Temperature Conditions	36 (.23%)
Eye	34 (.21%)
Gastrointestinal Hemorrhages	34 (.21%)
Hepatic And Hepatobiliary	33 (.21%)
Musculoskeletal And Connective Tiss...	32 (.2%)
Heart Failures	31 (.2%)
Electrolyte And Fluid Balance Condi...	29 (.18%)
Glucose Metabolism Disorders	29 (.18%)
Schizophrenia And Other Psychotic	29 (.18%)
Cranial Nerve Disorders	28 (.18%)
Gastrointestinal Inflammatory Condi...	28 (.18%)
Dissociative	27 (.17%)
Fatal Outcomes	27 (.17%)
Procedural And Device Related Injur...	27 (.17%)
Psychiatric And Behavioural Symptom...	27 (.17%)
Toxicology And Therapeutic Drug Mon...	27 (.17%)
Water, Electrolyte And Mineral	27 (.17%)
Cardiac Valve	26 (.16%)
Myocardial	26 (.16%)
Miscellaneous And Site Unspecified ...	25 (.16%)
Ocular Infections, Irritations And ...	25 (.16%)
Sleep Disturbances	24 (.15%)
Inner Ear And Viiith Cranial Nerve	23 (.15%)
Manic And Bipolar Mood Disorders	23 (.15%)
Respiratory And Mediastinal Neoplas...	23 (.15%)
Viral Infectious	23 (.15%)
Cornification And Dystrophic Skin	22 (.14%)
Pulmonary Vascular	22 (.14%)
Renal And Urinary Tract Investigati...	22 (.14%)
Skin Vascular Abnormalities	21 (.13%)
Anemias Nonhemolytic And Marrow Dep...	19 (.12%)
Bacterial Infectious	19 (.12%)
Embolism And Thrombosis	19 (.12%)
Abortions And Stillbirth	18 (.11%)
Arteriosclerosis, Stenosis, Vascula...	18 (.11%)
Ocular Neuromuscular	18 (.11%)
Therapeutic Procedures And Supporti...	17 (.11%)
Gastrointestinal Neoplasms Malignan...	16 (.1%)
Hepatobiliary	16 (.1%)
Increased Intracranial Pressure And...	16 (.1%)
Pregnancy, Labour, Delivery And Pos...	16 (.1%)
Urinary Tract Signs	16 (.1%)
Changes In Physical Activity	15 (.09%)
Eating Disorders	15 (.09%)
Fungal Infectious	15 (.09%)

Share/Embed Graph Export Data

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