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SUMATRIPTAN

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Sumatriptan Adverse Events Reported to the FDA Over Time

How are Sumatriptan adverse event reports trending over time?

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

Most Common Sumatriptan Adverse Events Reported to the FDA

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

Drug Ineffective
2451 (13.54%)
Product Quality Issue
671 (3.71%)
Nausea
529 (2.92%)
Headache
480 (2.65%)
Migraine
395 (2.18%)
Vomiting
326 (1.8%)
Chest Pain
275 (1.52%)
Chest Discomfort
248 (1.37%)
Device Malfunction
236 (1.3%)
Dizziness
200 (1.1%)
Dyspnoea
199 (1.1%)
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Injection Site Pain
199 (1.1%)
Therapeutic Response Decreased
196 (1.08%)
Feeling Abnormal
165 (.91%)
Drug Administration Error
162 (.89%)
Pain
159 (.88%)
Malaise
156 (.86%)
Somnolence
152 (.84%)
Paraesthesia
151 (.83%)
Drug Interaction
130 (.72%)
Palpitations
127 (.7%)
Hypoaesthesia
119 (.66%)
Fatigue
115 (.64%)
Throat Tightness
113 (.62%)
Overdose
111 (.61%)
Hyperhidrosis
110 (.61%)
Myocardial Infarction
104 (.57%)
Product Substitution Issue
101 (.56%)
Flushing
98 (.54%)
Blood Pressure Increased
94 (.52%)
Muscle Tightness
94 (.52%)
Burning Sensation
90 (.5%)
Drug Exposure During Pregnancy
87 (.48%)
Pain In Extremity
87 (.48%)
Rash
83 (.46%)
Hypersensitivity
82 (.45%)
Anxiety
79 (.44%)
Arthralgia
78 (.43%)
Loss Of Consciousness
78 (.43%)
Adverse Event
76 (.42%)
Diarrhoea
70 (.39%)
Injection Site Haemorrhage
70 (.39%)
Asthenia
69 (.38%)
Heart Rate Increased
69 (.38%)
Medication Error
69 (.38%)
Hypertension
68 (.38%)
Incorrect Route Of Drug Administrat...
66 (.36%)
Neck Pain
66 (.36%)
Dysgeusia
65 (.36%)
Confusional State
64 (.35%)
Convulsion
63 (.35%)
Injection Site Irritation
63 (.35%)
Tremor
63 (.35%)
Pyrexia
62 (.34%)
Urticaria
62 (.34%)
Feeling Hot
59 (.33%)
Cerebrovascular Accident
57 (.31%)
Condition Aggravated
57 (.31%)
Drug Effect Decreased
56 (.31%)
Muscle Spasms
55 (.3%)
Abdominal Pain Upper
54 (.3%)
Serotonin Syndrome
53 (.29%)
Contusion
51 (.28%)
Therapeutic Response Delayed
50 (.28%)
Wrong Technique In Drug Usage Proce...
48 (.27%)
Musculoskeletal Stiffness
47 (.26%)
Abdominal Discomfort
46 (.25%)
Myalgia
46 (.25%)
Amnesia
45 (.25%)
Insomnia
45 (.25%)
Abdominal Pain
44 (.24%)
Cardiac Disorder
44 (.24%)
Vision Blurred
44 (.24%)
Pruritus
43 (.24%)
Erythema
42 (.23%)
Memory Impairment
41 (.23%)
Sensory Disturbance
41 (.23%)
Arteriospasm Coronary
40 (.22%)
Pain In Jaw
40 (.22%)
Expired Drug Administered
37 (.2%)
Fall
37 (.2%)
Drug Hypersensitivity
36 (.2%)
Epistaxis
36 (.2%)
Nasal Discomfort
36 (.2%)
Injection Site Haematoma
35 (.19%)
Pharyngeal Oedema
35 (.19%)
Agitation
34 (.19%)
Death
34 (.19%)
Muscular Weakness
33 (.18%)
Photophobia
33 (.18%)
Oedema Peripheral
32 (.18%)
Dyspepsia
31 (.17%)
Dysphagia
31 (.17%)
Ill-defined Disorder
31 (.17%)
Injection Site Swelling
31 (.17%)
Adverse Drug Reaction
30 (.17%)
Therapeutic Response Unexpected
30 (.17%)
Disorientation
29 (.16%)
Anaphylactic Shock
28 (.15%)
Colitis Ischaemic
28 (.15%)
Depression
28 (.15%)

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

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

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

Common Uses of Sumatriptan According to Those Reporting Adverse Events

Why are people taking Sumatriptan, according to those reporting adverse events to the FDA?

Migraine
6565
Drug Use For Unknown Indication
948
Headache
481
Product Used For Unknown Indication
293
Cluster Headache
104
Ill-defined Disorder
60
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Migraine Prophylaxis
17
Pain
17
Migraine Without Aura
12
Migraine With Aura
7
Foetal Exposure During Pregnancy
6
Drug Exposure During Pregnancy
6
Analgesia
5
Premenstrual Syndrome
4
Nausea
4
Contraception
4
Hemicephalalgia
3
Tension Headache
3
Insomnia
2
Asthma
2
Back Pain
2
Hypersensitivity
2
Accidental Exposure
2
Premedication
2
Sinus Headache
2
Maternal Exposure During Pregnancy
2
Ophthalmoplegic Migraine
1
Sleep Disorder
1
Periarthritis
1
Photophobia
1
Systemic Lupus Erythematosus
1
Lyme Disease
1
Vomiting
1
Joint Prosthesis User
1
Neuralgia
1
Menstrual Disorder
1
Tic
1
Occipital Neuralgia
1
Basilar Migraine
1
Post Lumbar Puncture Syndrome
1
Headache Postoperative
1

Drug Labels

LabelLabelerEffective
Sumatriptan SuccinateSUN PHARMACEUTICAL INDUSTRIES LIMITED12-AUG-09
Sumatriptan SuccinateJHP Pharmaceuticals LLC04-SEP-09
Sumatriptan SuccinateHikma Pharmaceutical28-SEP-09
Sumatriptan SuccinateStat Rx USA27-OCT-09
Sumatriptan SuccinateTeva Parenteral Medicines, Inc28-OCT-09
Sumatriptan SuccinateBedford Laboratories10-FEB-10
Sumatriptan SuccinateDispensing Solutions Inc.03-MAR-10
Sumatriptan SuccinateBedford Laboratories19-MAR-10
Sumatriptan SuccinatePhysicians Total Care, Inc.24-MAY-10
AlsumaUS WorldMeds, LLC21-JUN-10
Sumatriptan SuccinateMedVantx, Inc.22-SEP-10
Sumatriptan SuccinateRebel Distributors Corp01-DEC-10
ImitrexRebel Distributors Corp28-DEC-10
Sumatriptan SuccinateAPP Pharmaceuticals, LLC12-APR-11
Sumavel DoseproZogenix, Inc.01-JUN-11
Sumatriptan SuccinatePreferred Pharmaceuticals, Inc08-JUN-11
TreximetRebel Distributors Corp13-SEP-11
Sumatriptan SuccinatePar Pharmaceutical Inc28-NOV-11
ImitrexPhysicians Total Care, Inc.12-DEC-11
SumatriptanPhysicians Total Care, Inc.12-DEC-11
Sumatriptan SuccinateH.J. Harkins Company, Inc.29-DEC-11
Sumatriptan SuccinateWockhardt USA LLC.15-FEB-12
Sumatriptan SuccinateWockhardt Limited05-MAR-12
ImitrexGlaxoSmithKline LLC26-MAR-12
ImitrexGlaxoSmithKline LLC27-MAR-12
Sumatriptan SuccinateDr. Reddy's Laboratories Limited30-MAR-12
Sumatriptan SuccinateUnit Dose Services30-MAR-12
Sumatriptan Ranbaxy Pharmaceuticals Inc.01-MAY-12
ImitrexLake Erie Medical & Surgical Supply DBA Quality Care Products LLC02-MAY-12
Sumatriptan SuccinateRebel Distributors Corp08-MAY-12
SumatriptanSandoz Inc09-MAY-12
SumatriptanAurobindo Pharma Limited11-MAY-12
SumatriptanPreferred Pharmaceuticals, Inc.04-JUN-12
Sumatriptan SuccinateAmerican Health Packaging19-JUL-12
Sumatriptan SuccinateTeva Pharmaceuticals USA Inc30-JUL-12
Sumatriptan SuccinateSun Pharma Global FZE13-AUG-12
Sumatriptan SuccinateLake Erie Medical DBA Quality Care Products LLC30-AUG-12
SumatriptanNorthstar Rx LLC17-SEP-12
Sumatriptan SuccinateMylan Pharmaceuticals Inc.28-SEP-12
ImitrexGlaxoSmithKline LLC02-OCT-12
SumatriptanGreenstone LLC10-OCT-12
Sumatriptan SuccinateSTAT Rx USA LLC11-OCT-12
TreximetGlaxoSmithKline LLC07-NOV-12
Sumatriptan SuccinateCobalt Laboratories17-DEC-12
AlsumaPfizer Laboratories Div Pfizer Inc20-DEC-12
Sumatriptan SuccinateSagent Pharmaceuticals31-DEC-12
Sumatriptan SuccinateSandoz Inc31-JAN-13
Sumatriptan SuccinateTeva Pharmaceuticals USA Inc22-APR-13
SumatriptanAuroMedics Pharma LLC29-APR-13

Sumatriptan Case Reports

What Sumatriptan safety concerns are being reported by doctors and researchers in the medical literature?

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About Results

This report contains aggregated drug side effects and adverse events for Sumatriptan. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

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