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- Patient Information:
Details with Side Effects
The following adverse reactions are discussed in more detail in other sections of the prescribing information:
- 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 and 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 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)
(n = 309)
|Paresthesia (all types)||3||5||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|
|Vertigo||< 1||< 1||2||< 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.
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.
Read the Imitrex (sumatriptan succinate) Side Effects Center for a complete guide to possible side effects
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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