Imitrex Injection

• Overview
• Consumer Information
• Professional Information

 

Imitrex Injection Side Effects Center

What Is Imitrex Injection?

Imitrex Injection (sumatriptan succinate) is a selective serotonin receptor agonist used to treat migraine headaches. Imitrex is available as a generic drug.

What Are Side Effects of Imitrex Injection?

Common side effects of Imitrex Injection include:

• pain or chest tightness,
• weakness,
• stomach discomfort,
• mild headache (not a migraine),
• pressure or heavy feeling in any part of your body,
• discomfort in your nose or throat,
• dizziness,
• spinning sensation,
• muscle pain,
• neck pain or stiffness,
• flushing (warmth, redness, tingling under your skin),
• injection site reactions (pain, redness, bleeding, swelling, or bruising), and
• elevated blood pressure.

Tell your doctor if you have unlikely but serious side effects Imitrex Injection including:

• blue fingers/toes/nails,
• cold sensation of hands and feet,
• hearing changes,
• mental/mood changes, and
• seizures.

Dosage for Imitrex Injection

The maximum single recommended adult dose of Imitrex Injection is 6 mg injected subcutaneously (under the skin).

What Drugs, Substances, or Supplements Interact with Imitrex Injection?

Imitrex Injection may interact with other migraine headache medicines, or antidepressants. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant while using Imitrex Injection.

Imitrex Injection During Pregnancy and Breastfeeding

It is unknown if Imitrex Injection will harm a fetus. Your name may need to be listed on a sumatriptan pregnancy registry when you start using Imitrex Injection. Imitrex Injection can pass into breast milk and may harm a nursing baby. Do not breastfeed within 12 hours after using Imitrex Injection. If you use a breast pump during this time, throw out any milk you collect. Do not feed it to your baby.

Additional Information

Our Imitrex Injection Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Imitrex Injection Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using sumatriptan and call your doctor at once if you have:

• sudden and severe stomach pain and bloody diarrhea;
• severe chest pain, shortness of breath, irregular heartbeats;
• a seizure (convulsions);
• blood circulation problems in your legs or feet--cramps, tight or heavy feeling, numbness or tingling, muscle weakness, burning pain, cold feeling, color changes (pale or blue), hip pain;
• heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
• high levels of serotonin in the body--agitation, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting;
• increased blood pressure--severe headache, blurred vision, pounding in your neck or ears, anxiety, nosebleed; or
• signs of a stroke--sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance.

Common side effects may include:

• numbness, tingling, warmth, redness, or burning sensation;
• pressure or heavy feeling in any part of your body;
• dizziness, drowsiness, feeling weak or tired;
• neck pain or stiffness; or
• pain or redness where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Imitrex Injection (Sumatriptan Succinate Injection)

 

Imitrex Injection Professional Information

SIDE EFFECTS

The following serious adverse reactions are described below and elsewhere in 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]
• Hypersensitivity reactions [see CONTRAINDICATIONS, 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.

Migraine Headache

Table 1 lists adverse reactions that occurred in 2 U.S. placebo-controlled clinical trials in patients with migraines (Studies 2 and 3) 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 in Pooled Placebo-Controlled Trials in Patients with Migraine (Studies 2 and 3)

Adverse Reaction	IMITREX Injection 6 mg Subcutaneous (n = 547) %	Placebo (n = 370) %
Atypical sensations	42	9
Tingling	14	3
Warm/hot sensation	11	4
Burning sensation	7	<1
Feeling of heaviness	7	1
Pressure sensation	7	2
Feeling of tightness	5	<1
Numbness	5	2
Feeling strange	2	<1
Tight feeling in head	2	<1
Cardiovascular	7	9
Flushing	5	1
Chest discomfort	3	<1
Tightness in chest
Pressure in chest	2	<1
Ear, nose, and throat
Throat discomfort	3	<1
Discomfort: nasal cavity/sinuses	2	<1
Injection site reactiona	59	24
Miscellaneous
Jaw discomfort	2	0
Musculoskeletal
Weakness	5	<1
Neck pain/stiffness	5	<1
Myalgia	2	<1
Neurological
Dizziness/vertigo	12	4
Drowsiness/sedation	3	2
Headache	2	<1
Skin
Sweating	2	1
a 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 patients. There were insufficient data to assess the impact of race on the incidence of adverse reactions.

Cluster Headache

In the controlled clinical trials assessing the efficacy of IMITREX injection as a treatment for cluster headache (Studies 4 and 5), no new significant adverse reactions were detected that had not already been identified in trials of IMITREX in patients 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 injection, 0% placebo), nausea and vomiting (4% IMITREX injection, 0% placebo), and bronchospasm (1% IMITREX injection, 0% placebo).

Postmarketing Experience

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.

Cardiovascular

Hypotension, palpitations.

Neurological

Dystonia, tremor.

DRUG INTERACTIONS

Ergot-Containing Drugs

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, SNRIs, TCAs, and MAO inhibitors [see WARNINGS AND PRECAUTIONS].

Read the entire FDA prescribing information for Imitrex Injection (Sumatriptan Succinate Injection)

&Copy; Imitrex Injection Patient Information is supplied by Cerner Multum, Inc. and Imitrex Injection Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.