Slideshows Images Quizzes

Imitrex

Last reviewed on RxList: 11/22/2016
Imitrex Side Effects Center

Last reviewed on RxList 9/7/2016

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. 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).

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. 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). 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.

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.

Imitrex Consumer Information

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;
  • drowsiness;
  • 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)

Imitrex Professional Information

SIDE EFFECTS

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

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.

Cardiovascular

Hypotension, palpitations.

Neurological

Dystonia, tremor.

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

Related Resources for Imitrex

Health Solutions From Our Sponsors