IMITREX injection adverse reactions
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.