IMITREX injection adverse reactions

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Sumatriptan
IMITREX injection® FDA Package Insert
Indications and Usage
Dosage and Administration
Dosage Forms and Strengths
Contraindications
Warnings and Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Overdosage
Description
Clinical Pharmacology
Nonclinical Toxicology
Clinical Studies
How Supplied/Storage and Handling
Patient Counseling Information
Labels and Packages
IMITREX tablet® FDA Package Insert
Indications and Usage
Dosage and Administration
Dosage Forms and Strengths
Contraindications
Warnings and Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Overdosage
Description
Clinical Pharmacology
Nonclinical Toxicology
Clinical Studies
How Supplied/Storage and Handling
Patient Counseling Information
Labels and Packages
IMITREX spray® FDA Package Insert
Indications and Usage
Dosage and Administration
Dosage Forms and Strengths
Contraindications
Warnings and Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Overdosage
Description
Clinical Pharmacology
Nonclinical Toxicology
Clinical Studies
How Supplied/Storage and Handling
Patient Counseling Information
Labels and Packages
Clinical Trials on Sumatriptan
ClinicalTrials.gov

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

  1. "IMITREX (SUMATRIPTAN SUCCINATE) INJECTION [GLAXOSMITHKLINE LLC]".

Adapted from the FDA Package Insert.