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Sumatriptan (Sumatriptan) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Sumatriptan and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (78)
Death (5)
Life Threatening Events (4)
Disability (2)

Reports by Reaction Type

Drug Ineffective (18)Product Quality Issue (13)Maternal Drugs Affecting Foetus (6)Chest Discomfort (6)Apnoea (5)Nausea (5)Bradycardia (5)Product Substitution Issue (4)Hypersensitivity (4)Foetal Exposure During Pregnancy (4)Headache (4)Completed Suicide (4)

Below are a few examples of reports where side effects / adverse reactions may be related to Sumatriptan. For a complete list or a specific selection of reports, please use the links above.

Possible Sumatriptan side effects in male

Reported by a physician from United States on 2012-08-24

Patient: male

Reactions: Arthralgia, Tendonitis

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Ibuprofen
    Indication: Product Used FOR Unknown Indication

Sudafed 12 Hour
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Ibuprofen

Sumatriptan Succinate
    Indication: Migraine
    Start date: 2007-01-01

Sumatriptan
    Administration route: Oral
    Indication: Migraine
    Start date: 2007-01-01

Sudafed 12 Hour
    Administration route: Oral



Possible Sumatriptan side effects in 40 year old male

Reported by a physician from United States on 2012-08-24

Patient: 40 year old male

Reactions: Arthralgia, Tendonitis

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Sumatriptan
    Dosage: 6 mg, 1x/day
    Indication: Migraine
    Start date: 2007-01-01

Sudafed 12 Hour
    Dosage: unk
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Ibuprofen
    Dosage: unspecified
    Indication: Product Used FOR Unknown Indication

Sumatriptan
    Dosage: 100 mg, 1x/day
    Administration route: Oral
    Indication: Migraine
    Start date: 2007-01-01



Possible Sumatriptan side effects in 59 year old female

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: 59 year old female

Reactions: Vomiting, Drug Ineffective, Dehydration, Headache, Drug Dependence

Drug(s) suspected as cause:
Topamax
    Administration route: Oral
    Indication: Migraine

Sumatriptan
    Dosage: 100mg per day
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication



Possible Sumatriptan side effects in 64 year old male

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient: 64 year old male

Reactions: Flushing, Chest Discomfort, Mitral Valve Incompetence, Coronary Artery Disease, Tricuspid Valve Incompetence, Muscle Tightness

Drug(s) suspected as cause:
Imitrex
    Indication: Migraine

Sumatriptan
    Dosage: 6mg per day
    Indication: Cluster Headache
    Start date: 1995-07-01
    End date: 2012-07-20

Other drugs received by patient: Oxybutynin; Bupropion Hydrochloride; Synthroid; Percocet; Celebrex; Xanax; Simvastatin; Terazosin Hydrochloride; Androderm



Possible Sumatriptan side effects in female

Reported by a pharmacist from United States on 2012-08-22

Patient: female

Reactions: Drug Ineffective, Feeling Abnormal

Drug(s) suspected as cause:
Relpax
    Dosage: 20 mg, as needed
    Administration route: Oral
    Indication: Migraine
    Start date: 2011-01-01

Zomig
    Dosage: unk
    Indication: Migraine

Sumatriptan
    Dosage: unk
    Indication: Migraine



Possible Sumatriptan side effects in 22 year old female

Reported by a physician from United States on 2012-08-22

Patient: 22 year old female

Reactions: Myocardial Infarction, Cardiac Arrest

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Sumatriptan Succinate
    Dosage: unk

Sumatriptan
    Dosage: unk
    Indication: Migraine



Possible Sumatriptan side effects in 64 year old male

Reported by a consumer/non-health professional from United States on 2012-08-21

Patient: 64 year old male

Reactions: Flushing, Chest Discomfort, Mitral Valve Incompetence, Coronary Artery Disease, Tricuspid Valve Incompetence, Muscle Tightness

Drug(s) suspected as cause:
Imitrex
    Indication: Migraine

Sumatriptan
    Dosage: 6mg per day
    Indication: Cluster Headache
    Start date: 1995-07-01
    End date: 2012-07-20

Other drugs received by patient: Androderm; Synthroid; Bupropion Hydrochloride; Percocet; Celebrex; Simvastatin; Oxybutynin; Terazosin Hydrochloride; Xanax



Possible Sumatriptan side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-14

Patient: female

Reactions: Confusional State, Agitation, Nightmare, Drug Ineffective, Hyperglycaemia, Rash, Toxicity To Various Agents, Convulsion, Tremor, Weight Increased, Bipolar Disorder, Chest Pain

Drug(s) suspected as cause:
Trileptal

Tizanidine Hydrochloride
    Indication: Migraine

Depakote

Darvocet-N 50

Skelaxin

Prozac

Paxil

Lunesta

Beta Blocking Agents

Topamax

Zonegran

Valium
    Indication: Agitation

Reglan

Abilify

Elavil

Zyprexa

Tegretol

Requip

MAO Inhibitors

Remeron

Buspar

Adderall

Erythromycin

Ritalin

Effexor

Sumatriptan

Wellbutrin

Tofranil

Zoloft

Daytrana

Antidepressants

Steroids NOS

Desyrel

Neurontin

Sinequan

Seroquel

Pamelor

Other drugs received by patient: Aspirin; Vitamin B-Complex, Other Combinations; Ensure; Caltrate +D; ONE A DAY



Possible Sumatriptan side effects in 68 year old female

Reported by a consumer/non-health professional from United States on 2012-08-10

Patient: 68 year old female, weighing 70.3 kg (154.7 pounds)

Reactions: Product Substitution Issue, Migraine, Drug Ineffective

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Sumatriptan

Topiramate



Possible Sumatriptan side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-30

Patient: female

Reactions: Vomiting, Overdose, Dizziness

Drug(s) suspected as cause:
Sumatriptan
    Indication: Migraine
    Start date: 1999-01-01

Imitrex
    Dosage: 100mg see dosage text
    Administration route: Oral
    Indication: Migraine

Other drugs received by patient: Topamax; Neurontin; Inderal



Possible Sumatriptan side effects in 19 year old male

Reported by a consumer/non-health professional from United States on 2012-07-30

Patient: 19 year old male

Reactions: Malaise, Drug Ineffective, Adverse Drug Reaction

Drug(s) suspected as cause:
Sumatriptan



Possible Sumatriptan side effects in 32 year old male

Reported by a individual with unspecified qualification from United States on 2012-07-27

Patient: 32 year old male

Reactions: Intestinal Ischaemia, Prinzmetal Angina, Pancytopenia, Pulmonary Embolism, Atrial Fibrillation, Cardiomyopathy, Thrombophlebitis, Haemolytic Anaemia, Thrombocytopenia, Shock

Drug(s) suspected as cause:
Sumatriptan



Possible Sumatriptan side effects in

Reported by a individual with unspecified qualification from United States on 2012-07-18

Patient:

Reactions: Convulsion

Drug(s) suspected as cause:
Sumatriptan

Other drugs received by patient: Levocetiriz; Tizanidine Hydrochloride; Torsemide; Meloxicam; Bactrim



Possible Sumatriptan side effects in 59 year old female

Reported by a consumer/non-health professional from United States on 2012-07-17

Patient: 59 year old female, weighing 63.5 kg (139.7 pounds)

Reactions: Product Substitution Issue, Product Quality Issue, Drug Ineffective

Drug(s) suspected as cause:
Sumatriptan



Possible Sumatriptan side effects in 25 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-16

Patient: 25 year old female, weighing 68.0 kg (149.7 pounds)

Reactions: Pain Threshold Decreased

Drug(s) suspected as cause:
Sumatriptan



Possible Sumatriptan side effects in female

Reported by a consumer/non-health professional from United States on 2012-06-13

Patient: female

Reactions: Drug Effect Decreased

Drug(s) suspected as cause:
Treximet
    Indication: Product Used FOR Unknown Indication

Sumatriptan
    Indication: Product Used FOR Unknown Indication



Possible Sumatriptan side effects in female

Reported by a consumer/non-health professional from United States on 2012-05-30

Patient: female, weighing 69.9 kg (153.8 pounds)

Reactions: Off Label Use, Migraine

Drug(s) suspected as cause:
Zomig
    Administration route: Oral
    Indication: Migraine

Imitrex

Sumatriptan

Other drugs received by patient: Blood Pressure Medication



Possible Sumatriptan side effects in

Reported by a individual with unspecified qualification from France on 2012-05-16

Patient:

Reactions: Off Label Use, Visual Field Defect

Drug(s) suspected as cause:
Verapamil
    Dosage: 240 mg, twice daily
    Administration route: Oral
    Indication: Cluster Headache
    Start date: 2007-06-01

Verapamil
    Indication: Prophylaxis

Sumatriptan
    Dosage: 1-2 injections per month
    Indication: Cluster Headache
    Start date: 2007-06-01
    End date: 2010-02-01



Possible Sumatriptan side effects in 76 year old female

Reported by a pharmacist from United States on 2012-05-15

Patient: 76 year old female, weighing 77.1 kg (169.6 pounds)

Reactions: Nightmare

Drug(s) suspected as cause:
Sumatriptan



Possible Sumatriptan side effects in male

Reported by a consumer/non-health professional from United States on 2012-05-14

Patient: male

Reactions: Cytogenetic Abnormality, Dysmorphism, Maternal Drugs Affecting Foetus, Glaucoma, Pneumonia Aspiration, Micrognathia, Pierre Robin Syndrome, Caesarean Section, Cleft Palate, Developmental Delay, Respiratory Disorder Neonatal, Laryngomalacia, Gastrooesophageal Reflux Disease, Myopia, Ear Infection, Torticollis, Deafness Congenital, Respiratory Distress, Hyperbilirubinaemia Neonatal, Craniosynostosis, Bronchial Hyperreactivity, Respiratory Tract Infection

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Codeine Phosphate, Guaifenesin (Cheracol / 00693301 / )
    Dosage: transplacental
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-03-25

Olopatadine Hydrochloride
    Dosage: transplacental
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-03-25

Nitrofurantoin
    Dosage: transplacental
    Indication: Product Used FOR Unknown Indication

Cetirizine
    Dosage: transplacental
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-03-25

Azithromycin
    Dosage: transplacental
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-03-25

Topiramate
    Dosage: 50 mg (25 mg, 2 in 1 d), transplacental
    Indication: Migraine
    Start date: 2010-03-15
    End date: 2010-04-15

Amoxicillin
    Dosage: transplacental
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-03-25

Ibuprofen
    Dosage: transplacental
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-03-25

Hydrocodone Bitartrate and Acetaminophen
    Dosage: transplacental
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-03-25

Sumatriptan
    Dosage: transplacental
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-03-25

Fluticasone Propionate
    Dosage: transplacental
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-03-25

Cyclobenzaprine
    Dosage: 30 mg (10 mg, 3 in 1 d), transplacental
    Indication: Sciatic Nerve Injury

Naproxen
    Dosage: transplacental
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-03-25

Prenatal Vitamins (Prenatal Viotamins / 01549301 / )
    Dosage: transplacental
    Indication: Product Used FOR Unknown Indication



Possible Sumatriptan side effects in 14 year old female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-05-07

Patient: 14 year old female, weighing 59.0 kg (129.9 pounds)

Reactions: Chest Discomfort, Dyspnoea, Neck Pain, Gait Disturbance, Hypoaesthesia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Sumatriptan

Other drugs received by patient: Symbicort; Acetaminophen; Pizotifen; Montelukast



Possible Sumatriptan side effects in male

Reported by a consumer/non-health professional from United States on 2012-05-04

Patient: male

Reactions: Hyperbilirubinaemia, Maternal Drugs Affecting Foetus, Cytogenetic Abnormality, Glaucoma, Pierre Robin Syndrome, Deafness, Micrognathia, Body Dysmorphic Disorder, Cleft Palate, Caesarean Section, Developmental Delay, Cough, Dyspnoea, Chest Discomfort, Myopia, Craniosynostosis, Bronchial Hyperreactivity

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Cyclobenzaprine
    Dosage: 30 mg (10 mg, 3 in 1 d), transplacental
    Indication: Sciatic Nerve Injury

Amoxicillin
    Dosage: transplacental
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-03-25

Topiramate
    Dosage: 50;100;1w mg (25 mg, 2 in 1 d), transplacental
    Indication: Migraine

Naproxen
    Dosage: transplacental
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-03-25

Sumatriptan
    Dosage: transplacental
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-03-25

Nitrofurantoin
    Dosage: transplacental
    Indication: Product Used FOR Unknown Indication

Hydrocodone Bitartrate and Acetaminophen
    Dosage: transplacental
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-03-25

Prenatal Vitamins (Prenatal Vitamins (01549301)
    Dosage: transplacental
    Indication: Product Used FOR Unknown Indication

Fluticasone Propionate
    Dosage: transplacental
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-03-25

Azithromycin
    Dosage: transplacental
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-03-25

Ibuprofen
    Dosage: transplacental
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-03-25

Cetirizine
    Dosage: transplacental
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-03-25

Codeine Phosphate, Guaifenesin (Cheracol / 00693301 / )
    Dosage: transplacental
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-03-25

Olopatadine Hydrochloride
    Dosage: transplacental
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-03-25



Possible Sumatriptan side effects in 14 year old female

Reported by a pharmacist from United Kingdom on 2012-05-03

Patient: 14 year old female, weighing 59.0 kg (129.9 pounds)

Reactions: Chest Discomfort, Dyspnoea, Neck Pain, Gait Disturbance, Hypoaesthesia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Sumatriptan

Other drugs received by patient: Pizotifen; Montelukast; Acetaminophen; Symbicort



Possible Sumatriptan side effects in 38 year old female

Reported by a consumer/non-health professional from United States on 2012-04-27

Patient: 38 year old female, weighing 74.1 kg (163.0 pounds)

Reactions: Abdominal Discomfort, Drug Ineffective, Feeling Abnormal

Drug(s) suspected as cause:
Sumatriptan
    Dosage: 6mg single dose
    Indication: Migraine
    Start date: 2011-05-24
    End date: 2011-05-24

Zofran
    Indication: Abdominal Discomfort
    Start date: 2011-05-24
    End date: 2011-05-24

Other drugs received by patient: EYE Drops; Soma; Topamax; Prilosec



Possible Sumatriptan side effects in 19 year old female

Reported by a physician from United Kingdom on 2012-04-09

Patient: 19 year old female, weighing 60.0 kg (132.0 pounds)

Reactions: Hypersensitivity, Throat Irritation, Paraesthesia Oral, Chest Pain, Swollen Tongue

Drug(s) suspected as cause:
Sumatriptan

Other drugs received by patient: Beclomethasone Dipropionate; Albuterol



Possible Sumatriptan side effects in

Reported by a physician from Canada on 2012-04-05

Patient:

Reactions: Foetal Growth Restriction, Hypoglycaemia Neonatal, Maternal Drugs Affecting Foetus, Foetal Exposure During Pregnancy, Hypoglycaemia

Drug(s) suspected as cause:
Pantoprazole

Ondansetron
    Indication: Hyperemesis Gravidarum

Oxazepam

Hydroxyzine
    Dosage: 25mg four times per day
    Indication: Hyperemesis Gravidarum

Diphenhydramine HCL
    Dosage: 50mg four times per day
    Indication: Hyperemesis Gravidarum

Metoclopramide
    Indication: Hyperemesis Gravidarum

Cosyntropin

Humulin R

Sumatriptan

Aspirin

Thiamine HCL
    Indication: Hyperemesis Gravidarum

Multi-Vitamins
    Indication: Hyperemesis Gravidarum

Hydromorphone HCL

Insulin Aspart



Possible Sumatriptan side effects in

Reported by a physician from Canada on 2012-04-05

Patient:

Reactions: Foetal Growth Restriction, Foetal Exposure During Pregnancy, Hypoglycaemia

Drug(s) suspected as cause:
Oxazepam

Pantoprazole

Multi-Vitamins
    Indication: Hyperemesis Gravidarum

Hydroxyzine
    Dosage: 25mg four times per day
    Indication: Hyperemesis Gravidarum

Humulin R

Sumatriptan

Insulin Aspart

Ondansetron
    Indication: Hyperemesis Gravidarum

Aspirin

Diphenhydramine HCL
    Dosage: 50mg four times per day
    Indication: Hyperemesis Gravidarum

Metoclopramide
    Indication: Hyperemesis Gravidarum

Thiamine HCL
    Indication: Hyperemesis Gravidarum

Cosyntropin

Hydromorphone HCL



Possible Sumatriptan side effects in female

Reported by a individual with unspecified qualification from Germany on 2012-04-04

Patient: female, weighing 2.7 kg (5.9 pounds)

Reactions: Maternal Drugs Affecting Foetus, Bradycardia Neonatal, Infantile Apnoeic Attack

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Sumatriptan



Possible Sumatriptan side effects in 57 year old female

Reported by a consumer/non-health professional from United States on 2012-04-03

Patient: 57 year old female, weighing 62.6 kg (137.7 pounds)

Reactions: Rash, Blister

Drug(s) suspected as cause:
Sumatriptan



Possible Sumatriptan side effects in female

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-04-02

Patient: female, weighing 2.7 kg (5.9 pounds)

Reactions: Maternal Exposure During Pregnancy, Bradycardia, Apnoea

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Sumatriptan

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