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Imitrex

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Imitrex

Imitrex

SIDE EFFECTS

The following adverse reactions are discussed in more detail in other sections of the prescribing information:

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 clinic trials of another drug and may not reflect the rates observed in practice.

Table 1 lists adverse reactions that occurred in placebo-controlled clinical trials in patients who took at least 1 dose of study drug. Only treatment-emergent adverse reactions that occurred at a frequency of 2% or more in any group treated with IMITREX Tablets and that occurred at a frequency greater than the placebo group are included in Table 1.

Table 1: Adverse Reactions Reported by at Least 2% of Patients Treated With IMITREX Tablets and at a Greater Frequency Than Placebo

Adverse Reaction Percent of Patients Reporting
IMITREX Tablets 25 mg
(n = 417)
IMITREX Tablets 50 mg
(n = 771)
IMITREX Tablets 100 mg
(n = 437)
Placebo
(n = 309)
Atypical sensations 5 6 6 4
  Paresthesia (all types) 3 5 3 2
  Sensation warm/cold 3 2 3 2
Pain and other pressure sensations 6 6 8 4
  Chest - pain/tightness/pressure and/or heaviness 1 2 2 1
  Neck/throat/jaw - pain/tightness/pressure < 1 2 3 < 1
  Pain - location specified 2 1 1 1
  Other - pressure/tightness/heaviness 1 1 3 2
Neurological
  Vertigo < 1 < 1 2 < 1
Other
  Malaise/fatigue 2 2 3 < 1

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.

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. These reactions have been chosen for inclusion due to either their seriousness, frequency of reporting, or causal connection to IMITREX or a combination of these factors.

Cardiovascular: Hypotension, palpitations.

Neurological: Dystonia, tremor.

Read the Imitrex (sumatriptan succinate) Side Effects Center for a complete guide to possible side effects

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 Tablets within 24 hours of each other is contraindicated.

Monoamine Oxidase-A Inhibitors

MAO-A inhibitors increase systemic exposure by 7-fold. Therefore, the use of IMITREX Tablets in patients receiving MAO-A inhibitors is contraindicated [see CLINICAL PHARMACOLOGY].

Other 5-HT 1 Agonists

Because their vasospastic effects may be additive, co-administration of IMITREX Tablets 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 co-administration of triptans and SSRIs, SNRIs, TCAs, and MAO inhibitors [see WARNINGS AND PRECAUTIONS].

Last reviewed on RxList: 12/9/2013
This monograph has been modified to include the generic and brand name in many instances.

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Imitrex - User Reviews

Imitrex User Reviews

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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