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Sumatriptan is a selective agonist for 5-hydroxytryptamine1 (5-HT1B/1D) receptors. It is believed to exert its antimigraine effects by causing vasoconstriction of intracranial blood vessels, particularly those involved in migraine attacks, and by inhibiting the release of pro-inflammatory neuropeptides from trigeminal nerve endings.

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
In rare cases, allergic reactions can be fatal.
Signs of high blood pressure, including:
+ Severe headache
+ Dizziness
+ Passing out
+ Changes in eyesight
Seizures
Loss of eyesight (which can be long-lasting)
Abnormal sensations, such as:
+ Burning
+ Numbness
+ Tingling
Discoloration of the skin, lips, nail beds, fingers, or toes (blue or gray)
Gastrointestinal issues, including:
+ Diarrhea
+ Constipation
+ Severe stomach pain
+ Bloody diarrhea
Other symptoms, such as:
+ Belly pain after meals
+ Fever
+ Weight loss
+ Cramps and pain in legs or hips
+ Feeling of heaviness or tightness in the leg muscles
+ Feeling cold
+ Burning or aching pain in the feet or toes

Serotonin Syndrome: A Potentially Life-Threatening Condition

There is a risk of developing serotonin syndrome, a severe and potentially deadly condition, especially when taking certain other medications. If you experience any of the following symptoms, contact your doctor immediately:

Agitation
Changes in balance
Confusion
Hallucinations
Fever
Fast or abnormal heartbeat
Flushing
Muscle twitching or stiffness
Seizures
Shivering or shaking
Excessive sweating
Severe diarrhea
Upset stomach
Vomiting
Severe headache

Brain Blood Vessel Problems: A Rare but Serious Risk

In rare cases, this medication has been associated with brain blood vessel problems, including stroke. If you experience any of the following symptoms, contact your doctor immediately:

Weakness on one side of the body
Trouble speaking or thinking
Changes in balance
Drooping on one side of the face
Changes in eyesight

Other Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to contact your doctor if you notice any of the following:

Dizziness
Drowsiness
Fatigue
Weakness
Flushing
Feeling of warmth
Upset stomach
* Vomiting

If you have any questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction and its symptoms.
Certain health conditions, including:
+ High blood pressure
+ Liver disease
A history of specific health problems, such as:
+ Chest pain or pressure
+ Diseased arteries in the legs or arms
+ Heart attack
+ Heart disease
+ Poor blood flow in the heart, brain, bowel, or kidney
+ Stroke or transient ischemic attack (TIA)
+ Certain types of migraines, including hemiplegic or basilar migraines
+ Abnormal heart rhythms, such as Wolff-Parkinson-White syndrome
Recent use of certain antidepressant medications, including isocarboxazid, phenelzine, or tranylcypromine, within the last 14 days. Taking this medication within 14 days of these drugs can cause severe high blood pressure.
Concurrent use of another medication containing the same active ingredient.
Use of other medications for migraine or headache, such as:
+ Almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, or zolmitriptan, within the last 24 hours
+ Ergotamine, methysergide, dihydroergotamine, or similar medications, within the last 24 hours

This list is not exhaustive, and it is crucial to inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems. Ensure that it is safe to take this medication with all your other medications and health conditions. Do not start, stop, or change the dose of any medication without consulting your doctor.

Important Warnings and Precautions for Patients Taking This Medication

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This will help ensure your safety and prevent potential interactions with other treatments.

Caution with Daily Activities
Until you know how this medication affects you, avoid driving and engaging in activities that require you to be alert. This will help prevent accidents and ensure your safety.

Monitoring Blood Pressure
High blood pressure has been reported in patients taking this medication. Follow your doctor's instructions for regular blood pressure checks to monitor your condition.

Important Usage Information
This medication is not intended to prevent or reduce the frequency of migraine headaches. If you experience a headache that is different from your usual migraine headaches, consult your doctor before taking this medication.

Dosage and Administration
Taking more of this medication than prescribed by your doctor (higher dose, more frequent) may worsen your headaches. Use caution when taking this medication, especially if you have risk factors for heart disease, such as:

High blood pressure
High cholesterol
Overweight
High blood sugar or diabetes
Cigarette smoking
Male older than 40 years of age
Family history of early heart disease
Female after menopause

Discuss your individual risk factors with your doctor.

Cardiovascular Risks
Rare but serious heart problems, including heart attack and abnormal heartbeat, have occurred within a few hours of taking this medication. Seek immediate medical attention if you experience:

Chest, throat, neck, or jaw tightness, pain, pressure, or heaviness
Cold sweat
Shortness of breath
Fast heartbeat
Abnormal heartbeat
Severe dizziness or fainting

Special Considerations

Older Adults (65 and older): Use this medication with caution, as you may be more susceptible to side effects.
Pregnancy and Breastfeeding: Inform your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. Your doctor will discuss the benefits and risks of taking this medication with you.
* Children: This medication is not approved for use in children. However, your doctor may decide that the benefits of taking this medication outweigh the risks. If your child has been prescribed this medication, ask your doctor about the benefits and risks, and discuss any questions or concerns you may have.

• Monoamine Oxidase Inhibitors (MAOIs) (within 2 weeks of use)
• Ergotamine-containing medications (within 24 hours)
• Other 5-HT1 agonists (triptans) (within 24 hours)
• Severe hepatic impairment

• Selective Serotonin Reuptake Inhibitors (SSRIs) / Serotonin Norepinephrine Reuptake Inhibitors (SNRIs) (risk of serotonin syndrome)
• Ergot alkaloids (e.g., dihydroergotamine, methysergide) (risk of prolonged vasospastic reactions)
• Other triptans (e.g., zolmitriptan, rizatriptan) (additive vasoconstrictor effects)

• Propranolol (may increase sumatriptan exposure)
• St. John's Wort (potential for serotonin syndrome)

• Not available

• Chest pain or tightness (especially if radiating to arm/jaw)
• Shortness of breath
• Palpitations
• Dizziness or vertigo
• Numbness or tingling (paresthesia)
• Flushing
• Neck pain or stiffness
• Jaw pain or tightness
• Weakness or heaviness in limbs
• Signs of serotonin syndrome (agitation, hallucinations, rapid heart rate, fever, overactive reflexes, nausea, vomiting, diarrhea)

Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Limited human data are available.

Sumatriptan is excreted into human breast milk. Caution should be exercised. Consider pumping and discarding breast milk for 12 hours after a dose to minimize infant exposure.

Oral sumatriptan is not recommended for patients under 10 years of age for migraine. Efficacy and safety have not been established in pediatric patients for cluster headache. Nasal spray is approved for adolescents 10-17 years for migraine.

Use with caution. Elderly patients may be more susceptible to the cardiovascular effects of sumatriptan. Consider lower starting doses and monitor closely for adverse events, especially cardiovascular events.

• Sumatriptan is for acute treatment of migraine or cluster headache, not for prevention.
• Do not use in patients with a history of ischemic heart disease, uncontrolled hypertension, or cerebrovascular events.
• Patients should be screened for cardiovascular risk factors before starting therapy.
• Advise patients to take the medication as soon as migraine symptoms begin, but not during the aura phase if it precedes the headache.
• Warn patients about potential for chest, jaw, or neck tightness/pressure, which is usually non-cardiac but should be reported if severe or persistent.
• Avoid concomitant use with MAOIs, ergotamine-containing drugs, or other triptans.
• Educate patients on the signs and symptoms of serotonin syndrome when co-administered with SSRIs/SNRIs.

• Other Triptans (e.g., Zolmitriptan, Rizatriptan, Eletriptan, Frovatriptan, Naratriptan)
• CGRP Receptor Antagonists (e.g., Ubrogepant, Rimegepant)
• Ditans (e.g., Lasmiditan)
• NSAIDs (e.g., Ibuprofen, Naproxen)
• Acetaminophen
• Ergot alkaloids (e.g., Ergotamine, Dihydroergotamine)
• Anti-emetics (e.g., Metoclopramide, Prochlorperazine) for associated nausea/vomiting

If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide information about the medication taken, the amount, and the time it happened.