Tosymra

Tosymra (sumatriptan) Nasal Spray is a serotonin (5-HT1B/1D) receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura in adults. Common side effects of Tosymra Nasal Spray include:

• tingling,
• dizziness,
• spinning sensation (vertigo),
• warm/hot sensation,
• burning sensation,
• feeling of heaviness,
• pressure sensation,
• flushing,
• feeling of tightness,
• numbness,
• application site reactions,
• changes in taste, and
• throat irritation

Tosymra is taken as a single dose of 10 mg of nasal spray. Tosymra Nasal Spray may interact with ergotamine-containing or ergot-type medications, monoamine oxidase inhibitors (MAOIs), other triptans, selective serotonin reuptake inhibitors (SSRIs), serotonin–norepinephrine reuptake inhibitors (SNRIs), and tricyclic antidepressants (TCAs). Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant before using Tosymra Nasal Spray; it may harm a fetus. Tosymra Nasal Spray passes into breast milk but its effects on nursing infants are unknown. Consult your doctor before breastfeeding.

Our Tosymra (sumatriptan) Nasal Spray Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Tosymra 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);
• severe headache, blurred vision, pounding in your neck or ears;
• 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, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, vomiting, diarrhea; 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:

• pain or tight feeling in your chest, throat, or jaw;
• pressure or heavy feeling in any part of your body;
• numbness or tingling, feeling hot or cold;
• dizziness, drowsiness, weakness;
• unusual or unpleasant taste in your mouth after using the nasal medicine;
• pain, burning, numbness, or tingling in your nose or throat after using the nasal medicine; or
• runny or stuffy nose after using the nasal 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 Tosymra (Sumatriptan Nasal Spray)

 

Tosymra 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]
• Local Irritation [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.

Adverse Reactions In Placebo-Controlled Trials With Sumatriptan Injection

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

Adverse Reaction	Sumatriptan 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
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
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

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.

Adverse Reactions In Studies With TOSYMRA

In an open-label study that was designed to evaluate the local tolerability of TOSYMRA, repeated use of TOSYMRA was allowed over the course of 6 months. In this study, local irritative symptoms were reported in approximately 46% of patients treated with TOSYMRA, the most common of which were application site reactions (e.g., burning sensations in the nose), dysgeusia, and throat irritation [see WARNINGS AND PRECAUTIONS].

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of sumatriptan tablets, sumatriptan nasal spray, and sumatriptan 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.

Read the entire FDA prescribing information for Tosymra (Sumatriptan Nasal Spray)