Medical Editor: John P. Cunha, DO, FACOEP
Zembrace SymTouch (sumatriptan succinate) Injection is a serotonin (5-HT1B/1D) receptor agonist (triptan) indicated for acute treatment of migraine with or without aura in adults. Common side effects of Zembrace SymTouch include:
- injection site reactions,
- tingling,
- dizziness,
- spinning sensation (vertigo),
- warm/hot sensation,
- burning sensation,
- feeling of heaviness,
- pressure sensation,
- flushing,
- feeling of tightness,
- numbness,
- feeling strange,
- tight feeling in head,
- chest discomfort,
- tightness or pressure in chest,
- sore throat,
- sinus irritation,
- jaw discomfort,
- weakness,
- neck pain or stiffness,
- muscle pain,
- drowsiness,
- headache, or
- sweating.
The dose of Zembrace SymTouch for acute treatment of migraine is a single 3 mg dose. Zembrace SymTouch may interact with ergot-containing drugs, monoamine oxidase inhibitors (MAOIs), other 5-HT1agonists (e.g., triptans), selective serotonin reuptake inhibitors (SSRIs), and serotonin norepinephrine reuptake inhibitors (SNRIs). Tell your doctor all medications and supplements you use. Zembrace SymTouch is not recommended for use during pregnancy; it may harm a fetus. Zembrace SymTouch passes into breast milk. Avoid breastfeeding for 12 hours after treatment with Zembrace SymTouch Injection.
Our Zembrace SymTouch (sumatriptan succinate) Injection 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.
SLIDESHOW
Slideshow: 12 Surprising Headache Triggers Tips See Slideshow
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 US placebo-controlled clinical trials in migraine subjects (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 | Percent of Subjects Reporting | |
| 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 |
| 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.
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
Neurological
Read the entire FDA prescribing information for Zembrace SymTouch (Sumatriptan Succinate Subcutaneous Injection, USP)
