Slideshows Images Quizzes

Alsuma

Last reviewed on RxList: 10/20/2017
Alsuma Side Effects Center

Last reviewed on RxList 10/20/2017

Alsuma (sumatriptan) Auto-Injector is a triptan used to treat migraine headaches and cluster headaches. Alsuma will only treat a headache that has already begun. Alsuma will not prevent headaches or reduce the number of attacks. Alsuma should not be used to treat a common tension headache, a headache that causes loss of movement on one side of your body, or any headache that seems to be different from your usual migraine headaches. Common side effects of Alsuma include:

  • flushing (warmth, redness, or tingling under your skin)
  • sensations of tingling/numbness/prickling/heat, weakness, drowsiness, dizziness, spinning sensation, mild headache (not a migraine)
  • pressure or heavy feeling in any part of your body
  • discomfort in your nose or throat
  • muscle pain
  • neck pain or stiffness, or
  • injection site reactions (pain, redness, swelling, bleeding, or bruising)

The maximum single recommended adult dose of Alsuma is 6 mg injected subcutaneously. Alsuma may interact with antidepressants. Tell your doctor all medications and supplements you use. During pregnancy, Alsuma should be used only if prescribed. This drug passes into breast milk and may have undesirable effects on a nursing infant. Avoid breastfeeding for at least 12 hours after using Alsuma. Consult your doctor before breastfeeding.

Our Alsuma (sumatriptan) Auto-Injector Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

Alsuma Consumer Information

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

Stop using sumatriptan and call your doctor if you have a serious side effect such as:

  • feeling of pain or tightness in your jaw, neck, or throat;
  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
  • sudden numbness or weakness, especially on one side of the body;
  • sudden severe headache, confusion, problems with vision, speech, or balance;
  • sudden and severe stomach pain and bloody diarrhea;
  • seizure (convulsions);
  • numbness or tingling and a pale or blue-colored appearance in your fingers or toes; or
  • (if you are also taking an antidepressant) -- agitation, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting.

Less serious side effects may include:

  • 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;
  • warmth, redness, or mild tingling under your skin; or
  • pain, redness, bleeding, swelling, or bruising where you injected the medicine.

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 Alsuma (Sumatriptan Injection)

Alsuma Professional Information

SIDE EFFECTS

The following adverse reactions are discussed in more detail in other sections of the prescribing information:

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] following either a single 6-mg dose of sumatriptan injection or placebo. Only reactions that occurred at a frequency of 2% or more in groups treated with sumatriptan 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
Sumatriptan 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
  Flushing 7 2
  Chest Discomfort 5 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
  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 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 sumatriptan 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.

Cluster Headache

In the controlled clinical trials assessing the efficacy of sumatriptan 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 sumatriptan 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% sumatriptan, 0% placebo), nausea and vomiting (4% sumatriptan, 0% placebo), and bronchospasm (1% sumatriptan, 0% placebo).

Adverse Reactions Observed In Association With The Administration of ALSUMA

The safety of ALSUMA was evaluated in an open-label clinical trial evaluating the usability of ALSUMA during a migraine attack. Adverse reactions that occurred at a frequency of 5% or higher were injection site bruising (16%), injection site pain (6%), and injection site hemorrhage (6%).

Read the entire FDA prescribing information for Alsuma (Sumatriptan Injection)

Related Resources for Alsuma

Health Solutions From Our Sponsors