SUMATRIPTAN SUCCINATE

Sumatriptan Succinate Adverse Events Reported to the FDA Over Time

How are Sumatriptan Succinate adverse event reports trending over time?

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

Most Common Sumatriptan Succinate Adverse Events Reported to the FDA

What are the most common Sumatriptan Succinate adverse events reported to the FDA?

Drug Ineffective	2409 (14%)
Product Quality Issue	633 (3.68%)
Nausea	505 (2.94%)
Headache	470 (2.73%)
Migraine	385 (2.24%)
Vomiting	313 (1.82%)
Chest Pain	268 (1.56%)
Chest Discomfort	237 (1.38%)
Device Malfunction	225 (1.31%)
Injection Site Pain	194 (1.13%)
Therapeutic Response Decreased	193 (1.12%)
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Dizziness	190 (1.1%)
Dyspnoea	190 (1.1%)
Feeling Abnormal	162 (.94%)
Drug Administration Error	161 (.94%)
Malaise	154 (.9%)
Pain	153 (.89%)
Somnolence	145 (.84%)
Paraesthesia	139 (.81%)
Palpitations	119 (.69%)
Hypoaesthesia	116 (.67%)
Drug Interaction	113 (.66%)
Fatigue	112 (.65%)
Throat Tightness	108 (.63%)
Hyperhidrosis	105 (.61%)
Myocardial Infarction	102 (.59%)
Overdose	102 (.59%)
Blood Pressure Increased	93 (.54%)
Flushing	92 (.53%)
Muscle Tightness	91 (.53%)
Burning Sensation	89 (.52%)
Product Substitution Issue	85 (.49%)
Pain In Extremity	84 (.49%)
Rash	81 (.47%)
Anxiety	78 (.45%)
Drug Exposure During Pregnancy	77 (.45%)
Hypersensitivity	77 (.45%)
Adverse Event	76 (.44%)
Loss Of Consciousness	76 (.44%)
Arthralgia	75 (.44%)
Injection Site Haemorrhage	70 (.41%)
Asthenia	69 (.4%)
Diarrhoea	69 (.4%)
Medication Error	67 (.39%)
Heart Rate Increased	66 (.38%)
Dysgeusia	65 (.38%)
Hypertension	65 (.38%)
Incorrect Route Of Drug Administrat...	65 (.38%)
Neck Pain	64 (.37%)
Injection Site Irritation	63 (.37%)
Urticaria	62 (.36%)
Convulsion	58 (.34%)
Confusional State	57 (.33%)
Feeling Hot	57 (.33%)
Pyrexia	55 (.32%)
Condition Aggravated	54 (.31%)
Muscle Spasms	54 (.31%)
Abdominal Pain Upper	53 (.31%)
Drug Effect Decreased	53 (.31%)
Tremor	53 (.31%)
Cerebrovascular Accident	52 (.3%)
Serotonin Syndrome	51 (.3%)
Contusion	50 (.29%)
Therapeutic Response Delayed	50 (.29%)
Musculoskeletal Stiffness	47 (.27%)
Wrong Technique In Drug Usage Proce...	47 (.27%)
Myalgia	46 (.27%)
Abdominal Discomfort	45 (.26%)
Insomnia	45 (.26%)
Cardiac Disorder	44 (.26%)
Pruritus	43 (.25%)
Abdominal Pain	42 (.24%)
Erythema	42 (.24%)
Vision Blurred	42 (.24%)
Memory Impairment	41 (.24%)
Amnesia	39 (.23%)
Pain In Jaw	38 (.22%)
Arteriospasm Coronary	37 (.22%)
Drug Hypersensitivity	36 (.21%)
Epistaxis	36 (.21%)
Sensory Disturbance	36 (.21%)
Expired Drug Administered	35 (.2%)
Nasal Discomfort	34 (.2%)
Agitation	33 (.19%)
Fall	33 (.19%)
Pharyngeal Oedema	33 (.19%)
Death	32 (.19%)
Injection Site Haematoma	32 (.19%)
Photophobia	32 (.19%)
Dyspepsia	31 (.18%)
Injection Site Swelling	31 (.18%)
Oedema Peripheral	31 (.18%)
Ill-defined Disorder	30 (.17%)
Therapeutic Response Unexpected	30 (.17%)
Dysphagia	29 (.17%)
Adverse Drug Reaction	28 (.16%)
Anaphylactic Shock	28 (.16%)
Depression	28 (.16%)
Circulatory Collapse	27 (.16%)
Muscular Weakness	27 (.16%)
Speech Disorder	27 (.16%)

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

What are the most common Sumatriptan Succinate adverse events reported to the FDA?

Therapeutic And Nontherapeutic Effe...	3042 (17.68%)
Neurological	1156 (6.72%)
Gastrointestinal Signs	1071 (6.23%)
Headaches	885 (5.14%)
Product Quality Issues	744 (4.32%)
Medication Errors	581 (3.38%)
Administration Site Reactions	531 (3.09%)
Respiratory	495 (2.88%)
Epidermal And Dermal Conditions	308 (1.79%)
Musculoskeletal And Connective Tiss...	283 (1.65%)
Cardiac And Vascular Investigations	282 (1.64%)
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Procedural And Device Related Injur...	282 (1.64%)
Muscle	266 (1.55%)
Coronary Artery	211 (1.23%)
Anxiety Disorders	208 (1.21%)
Cardiac Disorder Signs	186 (1.08%)
Central Nervous System Vascular	177 (1.03%)
Allergic Conditions	169 (.98%)
Injuries	164 (.95%)
Movement Disorders	140 (.81%)
Skin Appendage Conditions	139 (.81%)
Vascular	132 (.77%)
Vision	132 (.77%)
Infections - Pathogen Unspecified	130 (.76%)
Lifestyle Issues	125 (.73%)
Cardiac Arrhythmias	121 (.7%)
Gastrointestinal Motility And Defec...	118 (.69%)
Joint	111 (.65%)
Mental Impairment	110 (.64%)
Upper Respiratory Tract Disorders	104 (.6%)
Seizures	101 (.59%)
Chemical Injury And Poisoning	93 (.54%)
Deliria	85 (.49%)
Psychiatric	81 (.47%)
Sleep Disorders	78 (.45%)
Physical Examination Topics	76 (.44%)
Vascular Hypertensive	73 (.42%)
Angiedema And Urticaria	70 (.41%)
Mood Disorders	67 (.39%)
Neuromuscular	67 (.39%)
Decreased And Nonspecific Blood Pre...	57 (.33%)
Body Temperature Conditions	56 (.33%)
Eye	56 (.33%)
Hearing	54 (.31%)
Oral Soft Tissue Conditions	54 (.31%)
Bone Disorders	48 (.28%)
Bronchial Disorders	48 (.28%)
Arteriosclerosis, Stenosis, Vascula...	47 (.27%)
Suicidal And Self-injurious Behavio...	46 (.27%)
Fatal Outcomes	45 (.26%)
Disturbances In Thinking	43 (.25%)
Inner Ear And Viiith Cranial Nerve	43 (.25%)
Depressed Mood Disorders	41 (.24%)
Ocular Sensory Symptoms	39 (.23%)
Urinary Tract Signs	38 (.22%)
Gastrointestinal Inflammatory Condi...	37 (.22%)
Hepatobiliary	34 (.2%)
Myocardial	34 (.2%)
Tongue Conditions	32 (.19%)
Hematology Investigations	31 (.18%)
Cardiac Valve	30 (.17%)
Gastrointestinal Conditions	29 (.17%)
Personality Disorders	29 (.17%)
Cranial Nerve Disorders	27 (.16%)
Metabolic, Nutritional And Blood Ga...	26 (.15%)
Dental And Gingival Conditions	25 (.15%)
Gastrointestinal Hemorrhages	25 (.15%)
Breast	24 (.14%)
Menstrual Cycle And Uterine Bleedin...	24 (.14%)
Neurological Disorders Of The Eye	24 (.14%)
Ocular Infections, Irritations And ...	24 (.14%)
Ocular Structural Change, Deposit A...	24 (.14%)
Renal Disorders	24 (.14%)
Gastrointestinal Ulceration And Per...	23 (.13%)
Therapeutic Procedures And Supporti...	23 (.13%)
Electrolyte And Fluid Balance Condi...	22 (.13%)
Enzyme	22 (.13%)
Toxicology And Therapeutic Drug Mon...	22 (.13%)
Abortions And Stillbirth	21 (.12%)
Embolism And Thrombosis	21 (.12%)
Aneurysms And Artery Dissections	20 (.12%)
Ocular Neuromuscular	20 (.12%)
Sleep Disturbances	19 (.11%)
Anterior Eye Structural Change, Dep...	18 (.1%)
Bacterial Infectious	18 (.1%)
Glucose Metabolism Disorders	18 (.1%)
Musculoskeletal And Connective Tiss...	18 (.1%)
Platelet	18 (.1%)
Salivary Gland Conditions	18 (.1%)
Anemias Nonhemolytic And Marrow Dep...	17 (.1%)
Lipid Analyses	17 (.1%)
Maternal Complications Of Labour An...	17 (.1%)
Pregnancy, Labour, Delivery And Pos...	17 (.1%)
Bone And Joint Injuries	16 (.09%)
Retina, Choroid And Vitreous Hemorr...	16 (.09%)
Tissue	16 (.09%)
Water, Electrolyte And Mineral	16 (.09%)
Aural	15 (.09%)
Heart Failures	15 (.09%)
Hepatic And Hepatobiliary	15 (.09%)
Psychiatric And Behavioural Symptom...	15 (.09%)

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