"Today, the U.S. Food and Drug Administration approved Topamax (topiramate) for prevention (prophylaxis) of migraine headaches in adolescents ages 12 to 17. This is the first FDA approval of a drug for migraine prevention in this age group. The me"...
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]
- 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]
- Anaphylactic/anaphylactoid reactions [see 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 clinical trials of another drug and may not reflect the rates observed in practice.
Table 1 lists adverse reactions that occurred in 2 US placebo-controlled clinical trials in migraine subjects [Studies 2 and 3, see Clinical Studies] 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.
Table 1: Adverse Reactions Reported by at Least 2% of
Subjects and at a Greater Frequency Than Placebo in 2 Placebo-Controlled
Migraine Clinical Trials (Studies 2 and 3)a
|Adverse Reaction||Percent of Subjects Reporting|
|IMITREX Injection 6 mg Subcutaneous
(n = 547)
(n = 370)
|Burning sensation||7||< 1|
|Feeling of heaviness||7||1|
|Feeling of tightness||5||< 1|
|Feeling strange||2||< 1|
|Tight feeling in head||2||< 1|
|Tightness in chest||3||< 1|
|Pressure in chest||2||< 1|
|Ear, nose, and throat|
|Throat discomfort||3||< 1|
|Discomfort: nasal cavity/sinuses||2||< 1|
|Injection site reactionb||59||24|
|Neck pain/stiffness||5||< 1|
|a The sum of the percentages cited is greater
than 100% because subjects may have experienced more than 1 type of adverse
reaction. Only reactions that occurred at a frequency of 2% or more in groups
treated with IMITREX Injection and occurred at a frequency greater than the
placebo groups are included.
b Includes injection site pain, stinging/burning, swelling, erythema, bruising, bleeding.
The incidence of adverse reactions in controlled clinical trials was not affected by gender or age of the subjects. There were insufficient data to assess the impact of race on the incidence of adverse reactions.
In the controlled clinical trials assessing the efficacy of IMITREX Injection as a treatment for cluster headache [Studies 4 and 5, see Clinical Studies], no new significant adverse reactions were detected that had not already been identified in trials of IMITREX in subjects with migraine.
Overall, the frequency of adverse reactions reported in the trials of cluster headache was generally lower than in the migraine trials. Exceptions include reports of paresthesia (5% IMITREX, 0% placebo), nausea and vomiting (4% IMITREX, 0% placebo), and bronchospasm (1% IMITREX, 0% placebo).
Other Adverse Reactions
In the paragraphs that follow, the frequencies of less commonly reported adverse reactions are presented. Reaction frequencies were calculated as the number of subjects reporting a reaction divided by the total number of subjects (N = 6,218) exposed to subcutaneous IMITREX Injection. All reported reactions are included except those already listed in the previous table. Reactions are further classified within body system categories and enumerated in order of decreasing frequency using the following definitions: frequent are defined as those occurring in at least 1/100 subjects, infrequent are those occurring in 1/100 to 1/1,000 subjects, and rare are those occurring in fewer than 1/1,000 subjects.
Gastrointestinal: Frequent was abdominal discomfort.
Musculoskeletal: Frequent were muscle cramps.
Respiratory: Infrequent was dyspnea.
Skin: Infrequent were erythema, pruritus, and skin rashes.
Miscellaneous: Infrequent was “serotonin agonist effect”.
Adverse Events Observed With Other Formulations of IMITREX
The following adverse events occurred in clinical trials with IMITREX® Tablets and IMITREX® Nasal Spray. Because the reports include events observed in open and uncontrolled trials, the role of IMITREX in their causation cannot be reliably determined. All reported events are included except those already listed, those too general to be informative, and those not reasonably associated with the use of the drug.
Gastrointestinal: Abdominal distention and colitis.
Neurological: Convulsions, hallucinations, syncope, suicide, and twitching.
Miscellaneous: Edema, hypersensitivity, swelling of extremities, and swelling of face.
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.
Ear, Nose, and Throat: Deafness.
Eye: Ischemic optic neuropathy, retinal artery occlusion, retinal vein thrombosis.
Non-Site Specific: Angioedema, cyanosis, temporal arteritis.
Skin: Exacerbation of sunburn, hypersensitivity reactions (allergic vasculitis, erythema, pruritus, rash, shortness of breath, urticaria), photosensitivity. Following subcutaneous administration of IMITREX, pain, redness, stinging, induration, swelling, contusion, subcutaneous bleeding, and, on rare occasions, lipoatrophy (depression in the skin) or lipohypertrophy (enlargement or thickening of tissue) have been reported.
Urogenital: Acute renal failure.
Read the Imitrex Injection (sumatriptan succinate injection) 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 Injection within 24 hours of each other is contraindicated.
Monoamine Oxidase-A Inhibitors
MAO-A inhibitors increase systemic exposure by 2-fold. Therefore, the use of IMITREX Injection in patients receiving MAO-A inhibitors is contraindicated [see CLINICAL PHARMACOLOGY].
Other 5-HT1 Agonists
Because their vasospastic effects may be additive, coadministration of IMITREX Injection 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 coadministration of triptans and SSRIs, or SNRIs, SNRIs, TCAs, and MAO inhibitors [see WARNINGS AND PRECAUTIONS].
Last reviewed on RxList: 10/15/2012
This monograph has been modified to include the generic and brand name in many instances.
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