Side effects of imitrex

Imitrex and Chronic Headaches
An Interview with Dr. Allan Bernstein, Neurologist Trainers – We have a question about the use of Imitrex and why its use is often limited. Is it a health concern or is it too expensive for the insurance companies?

Dr. Bernstein – The answer is that it is both. It is very expensive. So there is some plain old economics involved. The second part is there is a real tendency to overuse it. When you do get relief using Imitrex, it is so dramatic that the tendency is to want to take it every time a headache threatens. People with headaches have been taught to take it at the first sign of a migraine. They have been told once a migraine is full blown, nothing is going to help. So the thought is “this headache is going to be a migraine”, fear of migraine becomes an issue. There can be a tendency is to take Imitrex immediately, at the first sign of headache even if the headache is not migraine.

The other problem is it is a pretty potent vasoconstrictor. People talk about chest tightness and changes in blood pressure, all of which are transient; but there is a hypothetical risk of heart attacks and strokes. Now, we haven’t seen this a lot, given how long it has been on the market and how many millions of doses have been used. It does appear to be a pretty safe drug. But frequent use raises questions about risk. Part of the answer to the question is the cost, part of the answer is potential risk and part of it is you may be treating the wrong headache.

One of the things we try to focus on is getting people to identify which headache is which.

A MIGRAINE is NOT A DAILY HEADACHE.

It is by definition an episodic event. Migraine headaches occur once a month or once a week, but generally not every single day. People who are using Imitrex 15, 20, 30 times a month may be treating their fear of migraine as much as they are treating migraine. They may be treating the wrong headache. They may be treating tension headaches or headaches related to neck tension; and in that case Imitrex is probably the wrong drug. There are better ways to treat tension headaches and headaches related to neck tension, such as The Natural Headache Relief Program.

Trainers – What you just said is really an important piece of information, about which people do not seem to be aware. In the Internet newsgroups where people are discussing headaches, they talk about “migraine” headaches and seem to be assuming all bad headaches are in the migraine category. What you are saying is imperative, because using Imitrex may not achieve the desired result. The tendency is for people to think Imitrex is the ultimate answer for all types of headache and it may not be the answer for their current headache pattern.

Dr. Bernstein – People will come to see me after they have seen 5 other doctors even other neurologists. Where I find the problem often has been, is that the patient uses the term “migraine”, and the doctor accepts the term without trying to sort out whether or not other types of headaches are present and distinguish the migraine from the non-migraine headache. People with migraine can have other types of headaches as well.

Trainers – Yes we have noticed that just about any really painful, serious or bad headache is automatically termed a migraine.

Dr. Bernstein – Yes, a bad headache is often called a “migraine” on TV. The “Excedrin commercials” discuss severe headaches as if they are all migraine. It is similar to the old sinus medicine commercials where the sinuses are throbbing. The inference was that the “Headache goes away when you squirt this medicine in your nose” or “take this tablet to relieve sinus headache”. Any throbbing headache was in the category of “Oh it’s my sinuses”, which is another misused term. Very few headaches are sinus headaches. There is a tendency in the media to talk about migraine without defining what migraine is. Also, overuse of some of non-prescription medications can cause rebound headaches.

Trainers – Does Imitrex cause rebound headaches?

Dr. Bernstein – Probably, there are people who take Imitrex everyday who develop headaches when the Imitrex wears off. So, then you have to go back and ask are they taking Imitrex for the right headache and when the Imitrex wears off do they then take two Excedrin or three Tylenol. Patients don’t always report to their physician how much non-prescription medication they take. They always talk about how much Imitrex they are taking but may not realize how important it is to report non-prescription medication.

Here is a typical scenario:
Patient- “My Imitrex is down to three a week.”
Doctor- “So that’s great, what are you taking in between?”
Patient-” Well, I just take Excedrin.”
Doctor- “How much Excedrin?”
Patient- “Oh, I take two”.
Doctor- ” How often do you take two?”
Patient- “Every three hours”.
Doctor- “That’s 16 a day”.
Patient- “Yeah, that’s about right. I take it everyday. I get up in the morning and I take it, as long as I keep taking it I’m okay. Then every now and then I really get nauseous and vomiting and I take my Imitrex.”

Something is wrong….what’s wrong with this picture? This person was sent by a neurologist who was treating their “migraine” and had gotten her down to three Imitrex a week which is still a lot. But she still had daily headaches. Nobody discussed the use of non-prescription medicine, and this is often not in the medical records and patients generally don’t volunteer this information.

Trainers – Are there other medications like Imitrex?

Dr. Bernstein – There are 3 other medications in the same chemical family as Imitrex, triptans. There’s Maxalt, Zomig,and Amerge. Amerge is slower in onset but a much longer acting drug than Imitrex. Amerge may have a physiological effect two to three times as long as Imitrex. So, for people who tell you they get a three day headache once a month, Amerge may be a better drug. Imitrex works very quickly but wears off very quickly. Maxalt and Zomig are in the middle, with a relatively fast onset but they last about twice as long as Imitrex. So more and more we are getting away from using Imitrex due to the availability of longer acting drugs and are using more Maxalt, Zomig and Amerge.

Trainers – How about tolerance to the triptans. Do people show tolerance if they are taking a lot of triptans on a regular basis?

Dr. Bernstein – There are people who start using Imitrex and tell you it works great, then tell you 6 months later it doesn’t work anymore. You always wonder if they are overusing it or are they getting rebound headaches from other drugs such as Excedrin or Tylenol or are they taking it for the wrong headache. But does it wear off? I think it does become less effective if used too frequently. I think all the triptans are very good drugs for episodic headaches. For twice a month headaches, even if they are three day headaches each, they are wonderful drugs…if you take them twice a month. If you are taking them multiple times a week you are in trouble, you may need to look for alternative treatments.

sumatriptan (oral/nasal) (Imitrex, Imitrex Nasal, Onzetra Xsail)

Brand Names: Imitrex, Imitrex Nasal, Onzetra Xsail

Generic Name: sumatriptan (oral/nasal)

  • What is sumatriptan (Imitrex, Imitrex Nasal, Onzetra Xsail)?
  • What are the possible side effects of sumatriptan (Imitrex, Imitrex Nasal, Onzetra Xsail)?
  • What is the most important information I should know about sumatriptan (Imitrex, Imitrex Nasal, Onzetra Xsail)?
  • What should I discuss with my healthcare provider before using sumatriptan (Imitrex, Imitrex Nasal, Onzetra Xsail)?
  • How should I use sumatriptan (Imitrex, Imitrex Nasal, Onzetra Xsail)?
  • What happens if I miss a dose (Imitrex, Imitrex Nasal, Onzetra Xsail)?
  • What happens if I overdose (Imitrex, Imitrex Nasal, Onzetra Xsail)?
  • What should I avoid while using sumatriptan (Imitrex, Imitrex Nasal, Onzetra Xsail)?
  • What other drugs will affect sumatriptan (Imitrex, Imitrex Nasal, Onzetra Xsail)?
  • Where can I get more information (Imitrex, Imitrex Nasal, Onzetra Xsail)?

What is sumatriptan (Imitrex, Imitrex Nasal, Onzetra Xsail)?

Sumatriptan is a headache medicine that narrows blood vessels around the brain. Sumatriptan also reduces substances in the body that can trigger headache pain, nausea, sensitivity to light and sound, and other migraine symptoms.

Sumatriptan is used to treat migraine headaches in adults. Sumatriptan will only treat a headache. This medicine will not prevent headaches or reduce the number of attacks.

Sumatriptan should not be used to treat a common tension headache or a headache that causes loss of movement on one side of your body. Use this medicine only if your condition has been confirmed by a doctor as migraine headaches.

Sumatriptan may also be used for purposes not listed in this medication guide.

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Imitrex 100 mg

triangular, pink, imprinted with IMITREX, 100

Imitrex 100 mg-New

triangular, pink, imprinted with IMITEX 100, LOGO

Imitrex 25 mg

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Imitrex 50 mg

triangular, white, imprinted with IMITREX, 50

Imitrex 50 mg-New

triangular, white, imprinted with IMITREX 50, LOGO

Imitrex Nasal Sumatriptan 100 mg-TEV

oblong, pink, imprinted with 93, 224

Sumatriptan 25 mg-TEV

oblong, white, imprinted with 93, 222

Sumatriptan 50 mg-TEV

oblong, white, imprinted with 93, 223

What are the possible side effects of sumatriptan (Imitrex, Imitrex Nasal, Onzetra Xsail)?

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using sumatriptan and call your doctor at once if you have:

  • sudden and severe stomach pain and bloody diarrhea;
  • severe chest pain, shortness of breath, irregular heartbeats;
  • a seizure (convulsions);
  • blood circulation problems in your legs or feet–cramps, tight or heavy feeling, numbness or tingling, muscle weakness, burning pain, cold feeling, color changes (pale or blue), hip pain;
  • heart attack symptoms–chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
  • high levels of serotonin in the body–agitation, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting;
  • increased blood pressure–severe headache, blurred vision, pounding in your neck or ears, anxiety, nosebleed; or
  • signs of a stroke–sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance.

Common side effects may include:

  • pain or tight feeling in your chest, throat, or jaw;
  • pressure or heavy feeling in any part of your body;
  • numbness or tingling, feeling hot or cold;
  • dizziness, drowsiness, weakness;
  • unusual or unpleasant taste in your mouth after using the nasal medicine;
  • pain, burning, numbness, or tingling in your nose or throat after using the nasal medicine; or
  • runny or stuffy nose after using the nasal medicine.

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 the most important information I should know about sumatriptan (Imitrex, Imitrex Nasal, Onzetra Xsail)?

You should not use this medicine if you have uncontrolled high blood pressure, heart problems, certain heart rhythm disorders, a history of heart attack or stroke, or circulation problems that cause a lack of blood supply within the body.

Do not use this medicine if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine.

Do not use sumatriptan within 24 hours before or after using any other migraine headache medicine.

Sumatriptan Side Effects

Medically reviewed by Drugs.com. Last updated on Feb 7, 2019.

  • Overview
  • Side Effects
  • Dosage
  • Professional
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In Summary

Commonly reported side effects of sumatriptan include: dizziness, injection site reaction, vertigo, nausea and vomiting, flushing sensation, tingling sensation, and unpleasant taste. Other side effects include: asthenia, burning sensation, chest discomfort, neck pain, neck stiffness, numbness, throat irritation, feeling of heaviness, flushing, sensation of pressure, and sensation of tightness. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to sumatriptan: oral tablet

Other dosage forms:

  • nasal powder, nasal spray
  • subcutaneous kit, subcutaneous solution
  • transdermal patch device assisted

Along with its needed effects, sumatriptan may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking sumatriptan:

Less common

  • Abdominal or stomach pain
  • anxiety
  • blurred vision
  • changes in patterns and rhythms of speech
  • chest pain or tightness
  • chills
  • confusion
  • dizziness
  • fast, slow, irregular, pounding, or racing heartbeat or pulse
  • headache
  • muscle cramps and stiffness
  • neck, throat, or jaw pain
  • nightmares
  • shivering
  • sweating
  • swelling of the fingers, hands, feet, or lower legs
  • tightness in the chest
  • trouble breathing

Rare

  • Blindness
  • chest pain or discomfort
  • chest tightness or heaviness
  • flushing or redness of the skin, especially on the face and neck
  • increased blinking or spasms of the eyelid
  • itching, pain, redness, or swelling
  • lightheadedness, dizziness, or fainting
  • nerve pain
  • severe numbness, especially on one side of the face or body
  • severe or continuing stomach pain
  • trouble speaking or swallowing
  • twitching
  • unusual bleeding or bruising
  • vomiting of blood or material that looks like coffee grounds
  • weakness of the arms and legs

Incidence not known

  • Agitation
  • back, leg, or stomach pains
  • bleeding gums
  • changes in vision
  • muscle twitching
  • pinpoint red spots on the skin
  • poor coordination
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • restlessness
  • skin rash, hives, or itching
  • unexplained bleeding or bruising
  • unusually warm skin
  • weakness in the arm or leg on one side of the body, sudden and severe

Some side effects of sumatriptan may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

  • Burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings
  • change in color vision
  • change in hearing
  • difficulty with concentrating
  • drowsiness
  • heartburn
  • increased sensitivity of the eyes to sunlight
  • joint pain
  • muscle aching or cramping
  • muscle stiffness or tightness
  • swollen joints
  • trouble sleeping

Rare

  • Aggressiveness
  • belching
  • change in taste
  • feeling halos around lights
  • increased sensitivity to pain
  • loss of appetite
  • numbness, pain, tingling, or weakness
  • stomach discomfort or upset
  • tingling in the hands and feet
  • tunnel vision
  • weakness

For Healthcare Professionals

Applies to sumatriptan: nasal capsule, nasal spray, oral tablet, subcutaneous kit, subcutaneous solution, transdermal film extended release

General

The more commonly observed adverse reactions have included those of pressure sensation, flushing, tingling, dizziness/vertigo, warm/hot sensation, burning sensation, flushing, and numbness; formulation specific events including injection site reactions, application site pain, and nasal discomfort have been reported.

Cardiovascular

Life-threatening disturbances of cardiac rhythm, such as ventricular tachycardia and ventricular fibrillation leading to death, and rare reports of acute myocardial infarction, have been reported within a few hours after administration of 5-HT1 agonists.

Chest discomfort is usually noncardiac in origin. A survey of 453 migraine patients found chest symptoms occurred in up to 58% of patients in at least some attacks and in up to 42% of patients in all attacks.

One study of 735 consecutive migraine patients reported that chest symptoms are frequent, but rarely important adverse effects of (primarily subcutaneous) sumatriptan. The risk of chest symptoms was reported to be patient dependent and not related, even opposite, to cardiovascular disease. This report contradicts the hypothesis that chest symptoms after sumatriptan are caused by cardiac ischemia.

Another study of 125 patients concluded that panic-like symptoms may explain the chest pain and related side effects after sumatriptan administration in patients with high levels of anxiety.

Uncommon (0.1% to 1%): Bradycardia, hypertension, hypotension, palpitations, pulsating sensations, tachycardia, 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)

Rare (less than 0.1%): Abnormal pulse, arrhythmia, pallor, Raynaud’s phenomenon, vasodilation

Frequency not reported: Abdominal aortic aneurysm, angina, atherosclerosis, cerebrovascular lesion, coronary artery vasospasm, edema, heart block, peripheral cyanosis, phlebitis, thrombosis, transient myocardial ischemia

Postmarketing reports: Cyanosis, hypotension, myocardial infarction, palpitations

Nervous system

Very common (10% or more): Dizziness (10%), abnormal taste (20%; nasal powder)

Common (1% to 10%): Bad/unusual taste, drowsiness/sedation, dystonia, headache, hypoesthesia, paraesthesia (all types), tremor

Uncommon (0.1% to 1%): Syncope

Rare (less than 0.1%): Difficulties in concentration, disturbances of smell, dysarthria, dysesthesia, hyperesthesia, monoplegia/diplegia, myoclonia, transient hemiplegia

Frequency not reported: Bradylogia, cerebral ischemia, cerebrovascular lesion, cluster headache, convulsions, facial paralysis, incoordination, increased alertness, memory disturbance, migraine, motor dysfunction, neuralgia, nystagmus, paralysis, radiculopathy, raised intracranial pressure, seizures, speech disturbance

Postmarketing reports: Central nervous system vasculitis, cerebellar infarction, cerebrovascular accident, subarachnoid hemorrhage, serotonin syndrome, temporal arteritis

Cerebral hemorrhage, subarachnoid hemorrhage, and stroke have occurred with 5-HT1 treatment; some have resulted in fatalities. One case of sumatriptan-induced cortical stroke has been reported in a patient with sagittal sinus thrombosis. In some cases, it appears possible that the cerebrovascular events were primary, and the 5-HT1 agonist administered in the belief that presenting symptoms were due to migraine when they were not. Patients with migraine may also be at an increased risk of certain cerebrovascular events such as stroke, hemorrhage, and transient ischemic attacks.

Medication overuse headache may present as migraine-like headaches or as a marked increase in frequency of migraine attacks.

Serotonin syndrome is characterized by mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination), and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). The onset of symptoms generally occurs within minutes to hours of receiving a new or a greater dose of a serotoninergic medications.

Seizures have been reported in patients with either a history of seizures or concurrent conditions predisposing to seizures and also in patients where no such predisposing factors are apparent.

Gastrointestinal

Common (1% to 10%): Abdominal discomfort, dysphagia, nausea and/or vomiting

Uncommon (0.1% to 1%): Diarrhea, gastroesophageal reflux

Rare (less than 0.1%): Flatulence/eructation, gallstones, peptic ulcer, retching

Frequency not reported: Abdominal distention, colitis, constipation, dental pain, disorder of mouth and tongue (e.g., burning of tongue, numbness of tongue, dry mouth), dyspeptic symptoms, feelings of gastrointestinal pressure, gastritis, gastroenteritis, gastrointestinal bleeding, gastrointestinal pain, hematemesis, hypersalivation, hyposalivation, intestinal obstruction, ischemic colitis, melena, oral itching and irritation, pancreatitis, salivary gland swelling, swallowing disorders

It is unclear whether the nausea and vomiting is related to sumatriptan therapy or to the underlying condition.

One report has suggested that “throat tightness” and chest pain associated with sumatriptan may sometimes be attributable to changes in esophageal motility.

Other

Very common (10% or more): Atypical sensations such as tingling, warm or hot sensations, vertigo

Common (1% to 10%): Atypical sensations such as burning sensation, chills, facial pain, fatigue, feeling of pressure, feeling strange, jaw discomfort, malaise, neck pain/stiffness, numbness, pain and other pressure sensations, pain where the location is specified, prickling sensations, stinging sensations, sensation of lightness, tight feeling in head, tightness or heaviness, weakness

Rare (less than 0.1%): Fever, intoxication, simultaneous hot and cold sensations, swelling of the extremities, tickling sensations

Frequency not reported: Abortion, contusions, ear infection, ear, nose, and throat hemorrhage, external otitis, feeling of fullness in the ear(s), hearing disturbances, hearing loss, Meniere’s disease, otalgia, overdose, photophobia, sensitivity to noise, swelling of face, tinnitus

Postmarketing reports: Deafness

Dermatologic

Very common (10% or more): Application site pain (26%; transdermal patch)

Common (1% to 10%): Sweating, allergic contact dermatitis and application site paresthesia/pruritus/warmth/discomfort/irritation/site discoloration (transdermal patch)

Uncommon (0.1% to 1%): Eruptions, erythema, pruritus, skin rashes

Rare (less than 0.1%): Skin tenderness

Frequency not reported: Dry/scaly skin, eczema, hematoma, hyperhidrosis, seborrheic dermatitis, skin nodules, tightness of skin, wrinkling of skin

Postmarketing reports: Allergic vasculitis, angioedema, exacerbation of sunburn, photosensitivity, urticaria, burns scars, severe redness, pain, skin discoloration, blistering and cracked skin with the iontophoretic transdermal system

Burns and scars have been reported on the skin where the transdermal iontophoretic transdermal system has been worn. These reports describe severe redness, pain, skin discoloration, blistering, and cracked skin. On June 13, 2016, the manufacturer of the patch suspended sales and distribution of the patch to investigate the cause of these reports.

Endocrine

Frequency not reported: Elevated thyrotropin stimulating hormone (TSH) levels, endocrine cysts, lumps, and masses, hypothyroidism

Genitourinary

Rare (less than 0.1%): Dysmenorrhea, dysuria

Frequency not reported: Abnormal menstrual cycle, bladder inflammation, breast swelling, breast tenderness, cysts, disorder of breasts, endometriosis, galactorrhea, hematuria, increased urination, inflammation of fallopian tubes, intermenstrual bleeding, lumps, masses of breasts, menstruation symptoms, micturition disorders, nipple discharge, urethritis, urinary infections

Hematologic

Frequency not reported: Anemia, lymphadenopathy

Postmarketing reports: Hemolytic anemia, pancytopenia, thrombocytopenia

Hepatic

Uncommon (0.1% to 1%): Minor disturbances in liver function tests

Hypersensitivity

Frequency not reported: Hypersensitivity reactions ranging from cutaneous hypersensitivity to anaphylaxis

Immunologic

Rare (less than 0.1%): Influenza

Frequency not reported: Herpes

Local

Very common (10% or more): Injection site reaction

Common (1% to 10%): Burning sensation (nasal administration)

Frequency not reported: Injection site stinging/burning, swelling, erythema, bruising, and bleeding

Postmarketing reports:

-Following subcutaneous administration: Contusion, induration, lipoatrophy, lipohypertrophy, pain, redness, stinging, subcutaneous bleeding, swelling

Local irritative symptoms were reported in clinical trials with sumatriptan nasal spray in approximately 5% of patients, and were severe in about 1% of cases. Symptoms were noted as being transient and generally resolved in less than 2 hours.

Metabolic

Uncommon (0.1% to 1%): Thirst

Rare (less than 0.1%): Dehydration, hunger, polydipsia, reduced appetite

Frequency not reported: Fluid disturbances, fluid retention, hyperglycemia, hypoglycemia, weight gain, weight loss

Musculoskeletal

Common (1% to 10%): Muscle cramps, myalgia

Uncommon (0.1% to 1%): Joint disturbances (pain, stiffness, swelling, ache)

Rare (less than 0.1%): Backache, muscle stiffness, muscle tiredness, need to flex calf muscles

Frequency not reported: Acquired musculoskeletal deformity, arthralgia, arthritis, articular rheumatitis, difficulty in walking, intervertebral disc disorder, muscle atrophy, muscle tightness and rigidity, musculoskeletal inflammation, rigidity, tetany, twitching

Ocular

Loss of vision included reports of permanent defects. Causality has not been established as visual disorders may occur during a migraine attack itself.

Common (1% to 10%): Vision alterations

Uncommon (0.1% to 1%): Irritation of the eye, lacrimation, photophobia

Frequency not reported: Accommodation disorders, blindness, conjunctivitis, diplopia. disorders of sclera, low vision, eye edema and swelling, eye hemorrhage, eye itching, eye pain, external ocular muscle disorders, flickering, keratitis, mydriasis, scotoma, visual disturbances

Postmarketing reports: Ischaemic optic neuropathy, retinal artery occlusion, retinal vein thrombosis

Oncologic

Frequency not reported: Neoplasm of pituitary, primary malignant breast neoplasm

Psychiatric

Common (1% to 10%): Anxiety

Uncommon (0.1% to 1%): Agitation, euphoria, mental confusion, relaxation

Rare (less than 0.1%): Depression, globus hystericus, hysteria, sleep disturbance

Frequency not reported: Aggressiveness, apathy, depressive disorders, detachment, disturbance of emotions, drug abuse, hallucinations, neurotic disorders, personality change, phobia, psychomotor disorders, stress, suicide

Renal

Rare (less than 0.1%): Renal calculus

Postmarketing reports: Acute renal failure

Respiratory

The consequences of repeated and prolonged use of the nasal spray on nasal and/or respiratory mucosa have not been established.

Very common (10% or more): Nasal discomfort (up to 11%; nasal powder)

Rare (less than 0.1%): Diseases of the lower respiratory tract, hiccoughs, yawning

Frequency not reported: Allergic rhinitis, asthma, breathing disorder, bronchitis, cough, nasal inflammation, sinusitis, upper respiratory tract inflammation, voice disturbances

Postmarketing reports: Shortness of breath (as part of hypersensitivity reaction)

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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MEDSAFE

Contraindications includes IHD & Prinzmetal’s angina

Chest pain or tightness is a common complaint with sumatriptan, occurring rapidly after injection with most episodes lasting 5 – 30 minutes, but sometimes for several hours. The IMMP data show that throat tightness is often linked with chest pain or tightness.

The reason for these events is unknown, however, sumatriptan is a potent vasoconstrictor and may cause some vasospasm of the coronary arteries. It is therefore contraindicated in patients with a history of ischaemic heart disease (IHD) or Prinzmetal’s angina, and should not be used in patients with risk factors for IHD without prior evaluation for underlying cardiovascular disease. Where cardiovascular disease is absent, and a trial of sumatriptan prescribed, the first dose should be given under supervision. There are a few reports in the literature of myocardial infarction, some fatal, in patients with known or unsuspected coronary artery disease taking sumatriptan. There are no such reports in New Zealand, but there are two reports of angina.

Sumatriptan is also contraindicated for 24 hours after using ergotamine preparations, and ergotamine should not be used within six hours after using sumatriptan. The combination may be strongly vasospastic.

No serious cardiac dysrhythmias reported

The great majority of reports of cardiac dysrhythmia are described as tachycardia or palpitations. No serious problems have been reported. These may reflect an autonomic disturbance which is also likely to be responsible for the episodes of dizziness and syncope or hot and cold feelings, shivering or sweating.

Some patients have experienced strange feelings, such as depersonalisation, after sumatriptan use. Patients should be warned of this possibility.

In general, adverse reactions to the use of sumatriptan are common but minor, and most last for only a very short period of time.

Reference
  1. Dalhof C. Headache recurrence after subcutaneous sumatriptan and early treatment. Lancet 1992;340:909.

Imitrex

SIDE EFFECTS

The following serious adverse reactions are described below and elsewhere in the labeling:

  • Myocardial ischemia, myocardial infarction, and Prinzmetal’s angina
  • Arrhythmias
  • Chest, throat, neck, and/or jaw pain/tightness/pressure
  • Cerebrovascular events
  • Other vasospasm reactions
  • Medication overuse headache
  • Serotonin syndrome
  • Increase in blood pressure
  • Hypersensitivity reactions
  • Seizures

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Migraine Headache

Table 1 lists adverse reactions that occurred in 2 US placebo-controlled clinical trials in migraine patients (Studies 2 and 3) following either a single 6-mg dose of IMITREX Injection or placebo. Only reactions that occurred at a frequency of 2% or more in groups treated with IMITREX Injection 6 mg and that occurred at a frequency greater than the placebo group are included in Table 1.

Table 1. Adverse Reactions in Pooled Placebo-Controlled Trials in Patients with Migraine (Studies 2 and 3)

IMITREX Injection 6 mg Subcutaneous
(n = 547) %
Placebo
(n = 370) %
Atypical sensations 42 9
Tingling 14 3
Warm/hot sensation 11 4
Burning sensation 7 < 1
Feeling of heaviness 7 1
Pressure sensation 7 2
Feeling of tightness 5 < 1
Numbness 5 2
Feeling strange 2 < 1
Tight feeling in head 2 < 1
Cardiovascular
Flushing 7 2
Chest discomfort 5 1
Tightness in chest 3 < 1
Pressure in chest 2 < 1
Ear, nose, and throat
Throat discomfort 3 < 1
Discomfort: nasal cavity/sinuses 2 < 1
Injection site reactiona 59 24
Miscellaneous
Jaw discomfort 2 0
Musculoskeletal
Weakness 5 < 1
Neck pain/stiffness 5 < 1
Myalgia 2 < 1
Neurological
Dizziness/vertigo 12 4
Drowsiness/sedation 3 2
Headache 2 < 1
Skin
Sweating 2 1
aIncludes injection site pain, stinging/burning, swelling, erythema, bruising, bleeding.

The incidence of adverse reactions 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 reactions.

Cluster Headache

In the controlled clinical trials assessing the efficacy of IMITREX Injection as a treatment for cluster headache (Studies 4 and 5), no new significant adverse reactions were detected that had not already been identified in trials of IMITREX in patients with migraine.

Overall, the frequency of adverse reactions reported in the trials of cluster headache was generally lower than in the migraine trials. Exceptions include reports of paresthesia (5% IMITREX, 0% placebo), nausea and vomiting (4% IMITREX, 0% placebo), and bronchospasm (1% IMITREX, 0% placebo).

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of IMITREX Tablets, IMITREX Nasal Spray, and IMITREX Injection. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Hypotension, palpitations.

Neurological

Dystonia, tremor.

Read the entire FDA prescribing information for Imitrex (Sumatriptan Succinate)

25 Oct Imitrex – Sumatriptan

Posted at 19:18h in Headache Fact Sheets, Headache Medication by headache

Imitrex is the first of a class of medications commonly referred to as the triptans. It is a specific medication for aborting migraine headaches. It is also effective in cluster headache as an abortive medication. It appears to act in migraine by binding to selected receptors for serotonin found in the blood vessels (5HT1b) and nerve endings (5HT1d). By binding to these receptors it keeps the migraine from developing or causes it to end. It does not appear to stop migraine auras.

Sumatriptan has been available in the United States since 1993. Formulations include a self-administered injection given under the surface of the skin (subcutaneous), nasal spray or oral tablets. In 2004, the tablets were reformulated to dissolve more quickly in the stomach. They are still swallowed as a conventional tablet, not an orally dissolving product. The injectable form is very rapid in its onset of action and can stop a migraine in 15 minutes in some patients. The oral form is slower and usually reaches its maximum effect within two hours. The nasal spray is somewhere between the other two in the amount of time it takes to begin working.

Injectable form

The injectable form contains 6 mg of sumatriptan. Doses should not be taken closer than one hour apart and then only if the first dose provided at least partial relief. Generally, it should not be used more than two days per week.

Side effects are common with this form of sumatriptan only because of how rapidly the medication enters the system. In most people, the side effects (e.g., a sensation of warmth, scalp, neck or chest tightness, and/or lightheadedness) pass very quickly and are not severe.

Oral form

The oral form comes in 25 mg, 50 mg and 100 mg tablets. The dose can be repeated after 2 hours. A maximum of 200 mg should be taken in any 24-hour period. While few patients require only 25 mg to stop a migraine, 50 mg and 100 mg are more effective. A physician can guide you to determine the most effective dose for you.

Nasal spray

The nasal spray is available in 5 mg and 20 mg per dose units. Both doses were effective in clinical trials, but practical use of these forms is still limited. As with the injectable form, both the oral and nasal spray forms should be used no more than two days per week. Side effects with both of these other forms are much less common and severe than the injectable. Triptans can be effective if taken at any time after the headache develops but provide pain-free relief best when taken early in the headache, while the pain is still mild.

The triptans need to be used with caution, if at all, in patients who have complicated forms of migraine such as basilar migraine or hemiplegic migraine. The same is true for patients who have poorly controlled high blood pressure. Patients who have cardiovascular, cerebrovascular or peripheral vascular disease affecting the blood vessels should not use this medication. Patients with risk factors such as high cholesterol, diabetes or high blood pressure may need further testing before using triptans.

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