Medical Editor: Melissa Conrad Stöppler, MD
What Is Imitrex?
Imitrex (sumatriptan) is a selective serotonin receptor agonist used in oral, intranasal or injectable dosage form to treat migraine headaches. Imitrex is available as a generic drug.
What Are Side Effects of Imitrex?
Imitrex may cause serious side effects including:
- sudden, severe stomach pain,
- diarrhea with or without the presence of blood,
- severe chest pain,
- pain in your jaw or shoulder,
- shortness of breath,
- irregular heartbeats,
- seizure (convulsions),
- leg cramps,
- numbness or tingling in your legs or feet,
- burning pain in your legs or feet,
- cold feeling in your legs or feet,
- color changes in your legs or feet,
- hip pain,
- nausea,
- vomiting,
- sweating or shivering,
- agitation,
- hallucinations,
- fever,
- muscle stiffness,
- loss of coordination,
- sudden numbness or weakness on one side of the body,
- slurred speech,
- difficulty seeing,
- poor balance, and
- sudden severe headache
Get medical help right away, if you have any of the symptoms listed above.
Common side effects of Imitrex are:
- mild headache (not a migraine),
- pain or chest tightness,
- pressure or heavy feeling in any part of your body,
- weakness,
- feeling hot or cold,
- dizziness,
- spinning sensation,
- drowsiness,
- nausea,
- vomiting,
- drooling,
- unusual taste in your mouth after using nasal spray,
- burning/numbness/pain/irritation in your nose or throat after using nasal spray, or
- flushing (warmth, redness, or tingling under the skin).
Seek medical care or call 911 at once if you have the following serious side effects:
- Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
- Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheadedness, or passing out;
- Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.
Dosage for Imitrex
The maximum single recommended adult dose of Imitrex Injection for the acute treatment of migraine or cluster headache is 6 mg injected subcutaneously. For the treatment of migraine, if side effects are dose limiting, lower doses (1 mg to 5 mg) of Imitrex may be used.
What Drugs, Substances, or Supplements Interact with Imitrex?
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).
Imitrex During Pregnancy and Breastfeeding
Tell your doctor if you are pregnant or plan to become pregnant while using Imitrex. It is unknown if Imitrex will harm a fetus. Your name may need to be listed on a sumatriptan pregnancy registry when you start using Imitrex. Imitrex passes into breast milk and may harm a nursing baby. Do not breastfeed within 12 hours after using Imitrex.
Additional Information
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.
SLIDESHOW
16 Surprising Headache Triggers and Tips for Pain Relief See SlideshowGet 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);
- severe headache, blurred vision, pounding in your neck or ears;
- 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, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, vomiting, diarrhea; 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.
QUESTION
Who suffers more frequently from migraine headaches? See AnswerSIDE EFFECTS
The following serious adverse reactions are described below and elsewhere in the labeling:
- Myocardial ischemia, myocardial infarction, and Prinzmetal’s angina [see WARNINGS AND PRECAUTIONS]
- Arrhythmias [see WARNINGS AND PRECAUTIONS]
- Chest, throat, neck, and/or jaw pain/tightness/pressure [see WARNINGS AND PRECAUTIONS]
- Cerebrovascular events [see WARNINGS AND PRECAUTIONS]
- Other vasospasm reactions [see WARNINGS AND PRECAUTIONS]
- Medication overuse headache [see WARNINGS AND PRECAUTIONS]
- Serotonin syndrome [see WARNINGS AND PRECAUTIONS]
- Increase in blood pressure [see WARNINGS AND PRECAUTIONS]
- Hypersensitivity reactions [see CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS]
- Seizures [see WARNINGS AND PRECAUTIONS]
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 U.S. placebo-controlled clinical trials in patients with migraines (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)
| Adverse Reaction | 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 | 2 |
| Drowsiness/sedation | 3 | 2 |
| Headache | 2 | <1 |
| Skin | ||
| Sweating | 2 | 1 |
| a Includes 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 injection, 0% placebo), nausea and vomiting (4% IMITREX injection, 0% placebo), and bronchospasm (1% IMITREX injection, 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.
Cardiovascular
Neurological
DRUG INTERACTIONS
Ergot-Containing Drugs
Ergot-containing drugs have been reported to cause prolonged vasospastic reactions. Because these effects may be additive, use of ergotamine-containing or ergot-type medications (like dihydroergotamine or methysergide) and IMITREX injection within 24 hours of each other is contraindicated.
Monoamine Oxidase-A Inhibitors
MAO-A inhibitors increase systemic exposure by 2-fold. Therefore, the use of IMITREX injection in patients receiving MAO-A inhibitors is contraindicated [see CLINICAL PHARMACOLOGY].
Other 5-HT1 Agonists
Because their vasospastic effects may be additive, coadministration of IMITREX injection and other 5-HT1 agonists (e.g., triptans) within 24 hours of each other is contraindicated.
Selective Serotonin Reuptake Inhibitors/Serotonin Norepinephrine Reuptake Inhibitors And Serotonin Syndrome
Cases of serotonin syndrome have been reported during coadministration of triptans and SSRIs, SNRIs, TCAs, and MAO inhibitors [see WARNINGS AND PRECAUTIONS].
Read the entire FDA prescribing information for Imitrex (Sumatriptan Succinate)
© Imitrex Patient Information is supplied by Cerner Multum, Inc. and Imitrex Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
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