IMITREX injection adverse reactions: Difference between revisions
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==Adverse Reactions== | |||
The following adverse reactions are discussed in more detail in other sections of the labeling: | |||
* Myocardial ischemia, myocardial infarction, and Prinzmetal’s angina [see Warnings and Precautions (5.1)] | |||
* Arrhythmias [see Warnings and Precautions (5.2)] | |||
* Chest, throat, neck, and/or jaw pain/tightness/pressure [see Warnings and Precautions (5.3)] | |||
* Cerebrovascular events [see Warnings and Precautions (5.4)] | |||
* Other vasospasm reactions [see Warnings and Precautions (5.5)] | |||
* Medication overuse headache [see Warnings and Precautions (5.6)] | |||
* Serotonin syndrome [see Warnings and Precautions (5.7)] | |||
* Increase in blood pressure [see Warnings and Precautions (5.8)] | |||
* Anaphylactic/anaphylactoid reactions [see Warnings and Precautions (5.9)] | |||
* Seizures [see Warnings and Precautions (5.10)] | |||
====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 subjects [Studies 2 and 3, see Clinical Studies (14.1)] 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.<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = IMITREX (SUMATRIPTAN SUCCINATE) INJECTION [GLAXOSMITHKLINE LLC] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=fee7d073-0b99-48f2-7985-0d8cf970894b | publisher = | date = | accessdate = }}</ref> | |||
==References== | ==References== | ||
Revision as of 06:43, 1 February 2014
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Sheng Shi, M.D. [2]
Adverse Reactions
The following adverse reactions are discussed in more detail in other sections of the labeling:
- Myocardial ischemia, myocardial infarction, and Prinzmetal’s angina [see Warnings and Precautions (5.1)]
- Arrhythmias [see Warnings and Precautions (5.2)]
- Chest, throat, neck, and/or jaw pain/tightness/pressure [see Warnings and Precautions (5.3)]
- Cerebrovascular events [see Warnings and Precautions (5.4)]
- Other vasospasm reactions [see Warnings and Precautions (5.5)]
- Medication overuse headache [see Warnings and Precautions (5.6)]
- Serotonin syndrome [see Warnings and Precautions (5.7)]
- Increase in blood pressure [see Warnings and Precautions (5.8)]
- Anaphylactic/anaphylactoid reactions [see Warnings and Precautions (5.9)]
- Seizures [see Warnings and Precautions (5.10)]
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 subjects [Studies 2 and 3, see Clinical Studies (14.1)] 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.[1]
References
Adapted from the FDA Package Insert.