"Jan. 23, 2013 -- Worrying about what may trigger a migraine attack adds to the discomfort of many people with migraines. But according to a new study from Denmark, much of that worry may be unfounded.
The researchers studied the effect of l"...
Imitrex Side Effects Center
Medical Editor: Melissa Conrad Stöppler, MD
Imitrex (sumatriptan) is a medication within the drug class, selective serotonin receptor agonists. Imitrex is available as a generic drug and is used in oral, intranasal or injectable dosage form to treat migraine headaches. Common side effects of Imitrex are pain or chest tightness, weakness and stomach discomfort. Imitrex is dosed from 4-100 mg a day depending on the dosage form used.
Drug interactions of Imitrex include sibutramine (Meridia); monoamine oxidase inhibitors (MAOIs) isocarboxazid (Marplan); selective serotonin reuptake inhibitors, fluoxetine (Prozac) and sertraline (Zoloft), serotonin; norepinephrine reuptake inhibitors, venlafaxine (Effexor)) and duloxetine (Cymbalta); and ergot-containing medications, dihydroergotamine (Migranal) and ergotamine (Methergine). The safety of using Imitrex during pregnancy has not been established and it is secreted in breast milk.
Our Imitrex Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Imitrex in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using sumatriptan and call your doctor if you have a serious side effect such as:
- feeling of pain or tightness in your jaw, neck, or throat;
- chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
- sudden numbness or weakness, especially on one side of the body;
- sudden severe headache, confusion, problems with vision, speech, or balance;
- sudden and severe stomach pain and bloody diarrhea;
- seizure (convulsions);
- numbness or tingling and a pale or blue-colored appearance in your fingers or toes; or
- (if you are also taking an antidepressant) -- agitation, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting.
Less serious side effects may include:
- mild headache (not a migraine);
- pressure or heavy feeling in any part of your body;
- feeling hot or cold;
- dizziness, spinning sensation;
- nausea, vomiting, drooling;
- unusual taste in your mouth after using the nasal spray;
- burning, numbness, pain or other irritation in your nose or throat after using the nasal spray; or
- warmth, redness, or mild tingling under your skin.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Imitrex (Sumatriptan Succinate) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Imitrex Overview - Patient Information: Side Effects
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Chest/jaw/neck tightness can commonly occur shortly after using sumatriptan. Only rarely are these signs of a serious condition. However, you may not be able to tell it apart from a serious reaction related to a lack of blood flow to the heart, brain or other parts of the body. Seek immediate medical attention if any of these unlikely but very serious (rarely fatal) side effects occur: chest pain, jaw/left arm pain, fainting, fast/irregular/pounding heartbeat, vision changes, weakness on one side of the body, confusion, slurred speech, sudden or severe stomach/abdominal pain, bloody diarrhea.
Tell your doctor immediately if any of these unlikely but serious side effects occur: blue fingers/toes/nails, cold sensation of hands/feet, hearing changes, mental/mood changes, seizures.
This medication may rarely cause a very serious condition called serotonin syndrome. The risk increases when this medication is taken with certain other drugs such as other "triptans" used to treat migraine headaches (e.g., rizatriptan, zolmitriptan), certain antidepressants including SSRIs (e.g., citalopram, fluoxetine, paroxetine) and NSRIs (e.g., duloxetine, venlafaxine), or a certain drug to treat obesity (sibutramine). Before taking this drug, tell your doctor if you take any of these medications. Serotonin syndrome may be more likely when you start or increase the dose of any of these medications. Seek immediate medical attention if you develop some of the following symptoms: hallucinations, unusual restlessness, loss of coordination, fast heartbeat, severe dizziness, high fever, severe nausea/vomiting/diarrhea, twitchy muscles.
A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Imitrex (Sumatriptan Succinate)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Imitrex FDA Prescribing Information: Side Effects
Serious cardiac events, including some that have been fatal, have occurred following the use of IMITREX Injection or Tablets. These events are extremely rare and most have been reported in patients with risk factors predictive of CAD. Events reported have included coronary artery vasospasm, transient myocardial ischemia, myocardial infarction, ventricular tachycardia, and ventricular fibrillation (see CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS).
Incidence in Controlled Clinical Trials
Table 2 lists adverse events that occurred in placebo-controlled clinical trials in patients who took at least 1 dose of study drug. Only events that occurred at a frequency of 2% or more in any group treated with IMITREX Tablets and were more frequent in that group than in the placebo group are included in Table 2. The events cited reflect experience gained under closely monitored conditions of clinical trials in a highly selected patient population. In actual clinical practice or in other clinical trials, these frequency estimates may not apply, as the conditions of use, reporting behavior, and the kinds of patients treated may differ.
Table 2: Treatment-Emergent Adverse Events Reported by at
Least 2% of Patients in Controlled Migraine Trialsa
|Adverse Event Type||Percent of Patients Reporting|
(N = 309)
|IMITREX 25 mg
(N = 417)
|IMITREX 50 mg
(N = 771)
|IMITREX 100 mg
(N = 437)
|Paresthesia (all types)||2%||3%||5%||3%|
|Pain and other pressure sensations||4%||6%||6%||8%|
|Chest - pain/tightness/pressure and/or heaviness||1%||1%||2%||2%|
|Neck/throat/jaw - pain/tightness/pressure||< 1%||< 1%||2%||3%|
|Pain - location specified||1%||2%||1%||1%|
|Other - pressure/tightness/heaviness||2%||1%||1%||3%|
|NeurologicalVertigo||< 1%||< 1%||< 1%||2%|
|a Events that occurred at a frequency of 2% or more in the group treated with IMITREX Tablets and that occurred more frequently in that group than the placebo group.|
Other events that occurred in more than 1% of patients receiving IMITREX Tablets and at least as often on placebo included nausea and/or vomiting, migraine, headache, hyposalivation, dizziness, and drowsiness/sleepiness.
IMITREX Tablets are generally well tolerated. Across all doses, most adverse reactions were mild and transient and did not lead to long-lasting effects. The incidence of adverse events in controlled clinical trials was not affected by gender or age of the patients. There were insufficient data to assess the impact of race on the incidence of adverse events.
Other Events Observed in Association With the Administration of IMITREX Tablets
In the paragraphs that follow, the frequencies of less commonly reported adverse clinical events are presented. Because the reports include events observed in open and uncontrolled studies, the role of IMITREX Tablets in their causation cannot be reliably determined. Furthermore, variability associated with adverse event reporting, the terminology used to describe adverse events, etc., limit the value of quantitative frequency estimates provided. Event frequencies are calculated as the number of patients who used IMITREX Tablets (25, 50, or 100 mg) and reported an event divided by the total number of patients (N = 6,348)exposed to IMITREX Tablets. All reported events are included except those already listed in the previous table, those too general to be informative, and those not reasonably associated with the use of the drug. Events are further classified within body system categories and enumerated in order of decreasing frequency using the following definitions: frequent adverse events are defined as those occurring in at least 1/100 patients, infrequent adverse events are those occurring in 1/100 to 1/1,000 patients, and rare adverse events are those occurring in fewer than 1/1,000 patients.
Atypical Sensations: Frequent were burning sensation and numbness. Infrequent was tight feeling in head. Rare were dysesthesia.
Cardiovascular: Frequent were palpitations, syncope, decreased blood pressure, and increased blood pressure. Infrequent were arrhythmia, changes in ECG, hypertension, hypotension, pallor, pulsating sensations, and tachycardia. Rare were angina, atherosclerosis, bradycardia, cerebral ischemia, cerebrovascular lesion, heart block, peripheral cyanosis, thrombosis, transient myocardial ischemia, and vasodilation.
Ear, Nose, and Throat: Frequent were sinusitis, tinnitus; allergic rhinitis; upper respiratory inflammation; ear, nose, and throat hemorrhage; external otitis; hearing loss; nasal inflammation; and sensitivity to noise. Infrequent were hearing disturbances and otalgia. Rare was feeling of fullness in the ear(s).
Endocrine and Metabolic: Infrequent was thirst. Rare were elevated thyrotropin stimulating hormone (TSH) levels; galactorrhea; hyperglycemia; hypoglycemia; hypothyroidism; polydipsia; weight gain; weight loss; endocrine cysts, lumps, and masses; and fluid disturbances.
Eye: Rare were disorders of sclera, mydriasis, blindness and low vision, visual disturbances, eye edema and swelling, eye irritation and itching, accommodation disorders, external ocular muscle disorders, eye hemorrhage, eye pain, and keratitis and conjunctivitis.
Gastrointestinal: Frequent were diarrhea and gastric symptoms. Infrequent were constipation, dysphagia, and gastroesophageal reflux. Rare were gastrointestinal bleeding, hematemesis, melena, peptic ulcer, gastrointestinal pain, dyspeptic symptoms, dental pain, feelings of gastrointestinal pressure, gastritis, gastroenteritis, hypersalivation, abdominal distention, oral itching and irritation, salivary gland swelling, and swallowing disorders.
Hematological Disorders: Rare was anemia.
Musculoskeletal: Frequent was myalgia. Infrequent was muscle cramps. Rare were tetany; muscle atrophy, weakness, and tiredness; arthralgia and articular rheumatitis; acquired musculoskeletal deformity; muscle stiffness, tightness, and rigidity; and musculoskeletal inflammation.
Neurological: Frequent were phonophobia and photophobia. Infrequent were confusion, depression, difficulty concentrating, disturbance of smell, dysarthria, euphoria, facial pain, heat sensitivity, incoordination, lacrimation, monoplegia, sleep disturbance, shivering, syncope, and tremor. Rare were aggressiveness, apathy, bradylogia, cluster headache, convulsions, decreased appetite, drug abuse, dystonic reaction, facial paralysis, hallucinations, hunger, hyperesthesia, hysteria, increased alertness, memory disturbance, neuralgia, paralysis, personality change, phobia, radiculopathy, rigidity, suicide, twitching, agitation, anxiety, depressive disorders, detachment, motor dysfunction, neurotic disorders, psychomotor disorders, taste disturbances, and raised intracranial pressure.
Skin: Frequent was sweating. Infrequent were erythema, pruritus, rash, and skin tenderness. Rare were dry/scaly skin, tightness of skin, wrinkling of skin, eczema, seborrheic dermatitis, and skin nodules.
Urogenital: Infrequent were dysmenorrhea, increased urination, and intermenstrual bleeding. Rare were abortion and hematuria, urinary frequency, bladder inflammation, micturition disorders, urethritis, urinary infections, menstruation symptoms, abnormal menstrual cycle, inflammation of fallopian tubes, and menstrual cycle symptoms.
Other Events Observed in the Clinical Development of IMITREX
The following adverse events occurred in clinical trials with IMITREX Injection and IMITREX Nasal Spray. Because the reports include events observed in open and uncontrolled studies, the role of IMITREX in their causation cannot be reliably determined. All reported events are included except those already listed, those too general to be informative, and those not reasonably associated with the use of the drug.
Atypical Sensations: Feeling strange, prickling sensation, tingling, and hot sensation.
Cardiovascular: Abdominal aortic aneurysm, abnormal pulse, flushing, phlebitis, Raynaud syndrome, and various transient ECG changes (nonspecific ST or T wave changes, prolongation of PR or QTc intervals, sinus arrhythmia, nonsustained ventricular premature beats, isolated junctional ectopic beats, atrial ectopic beats, delayed activation of the right ventricle).
Chest Symptoms: Chest discomfort.
Endocrine and Metabolic: Dehydration.
Ear, Nose, and Throat: Disorder/discomfort nasal cavity and sinuses, ear infection, Meniere disease, and throat discomfort.
Eye: Vision alterations.
Injection Site Reaction
Miscellaneous: Difficulty in walking, hypersensitivity to various agents, jaw discomfort, miscellaneous laboratory abnormalities, “serotonin agonist effect,” swelling of the extremities, and swelling of the face.
Mouth and Teeth: Disorder of mouth and tongue (e.g., burning of tongue, numbness of tongue, dry mouth).
Musculoskeletal: Arthritis, backache, intervertebral disc disorder, neck pain/stiffness, need to flex calf muscles, and various joint disturbances (pain, stiffness, swelling, ache).
Neurological: Bad/unusual taste, chills, diplegia, disturbance of emotions, sedation, globus hystericus, intoxication, myoclonia, neoplasm of pituitary, relaxation, sensation of lightness, simultaneous hot and cold sensations, stinging sensations, stress, tickling sensations, transient hemiplegia, and yawning.
Respiratory: Influenza and diseases of the lower respiratory tract and lower respiratory tract infection.
Skin: Skin eruption, herpes, and peeling of the skin.
Urogenital: Disorder of breasts, endometriosis, and renal calculus.
Postmarketing Experience (Reports for Subcutaneous or Oral Sumatriptan)
Thefollowing section enumerates potentially important adverse events that have occurred in clinical practice and that have been reported spontaneously to various surveillance systems. The events enumerated represent reports arising from both domestic and nondomestic use of oral or subcutaneous dosage forms of sumatriptan. The events enumerated include all except those already listed in the ADVERSE REACTIONS section above or those too general to be informative. Because the reports cite events reported spontaneously from worldwide postmarketing experience, frequency of events and the role of sumatriptan in their causation cannot be reliably determined. It is assumed, however, that systemic reactions following sumatriptan use are likely to be similar regardless of route of administration.
Ear, Nose, and Throat: Deafness.
Eye: Ischemic optic neuropathy, retinal artery occlusion, retinal vein thrombosis, loss of vision.
Hepatic: Elevated liver function tests.
Psychiatry: Panic disorder.
Respiratory: Bronchospasm in patients with and without a history of asthma.
Skin: Exacerbation of sunburn, hypersensitivity reactions (allergic vasculitis, erythema, pruritus, rash, shortness of breath, urticaria; in addition, severe anaphylaxis/anaphylactoid reactions have been reported [see WARNINGS]), photosensitivity.
Urogenital: Acute renal failure.
Drug Abuse And Dependence
One clinical study with IMITREX Injection enrolling 12 patients with a history of substance abuse failed to induce subjective behavior and/or physiologic response ordinarily associated with drugs that have an established potential for abuse.
Read the entire FDA prescribing information for Imitrex (Sumatriptan Succinate) »
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