ZEMBRACE SYMTOUCH SIDE EFFECTS
- Generic Name: sumatriptan succinate subcutaneous injection, usp
- Brand Name: Zembrace-SymTouch
SIDE EFFECTS
The following serious adverse reactions are described below and elsewhere in the labeling:
- Myocardial ischemia, myocardial infarction, and Prinzmetal’s angina
- Arrhythmias
- Chest, throat, neck, and/or jaw pain/tightness/pressure
- Cerebrovascular events
- Other vasospasm reactions
- Medication overuse headache
- Serotonin syndrome
- Increase in blood pressure
- Hypersensitivity reactions
- Seizures
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
Hypotension, palpitations
Neurological
Dystonia, tremor
SRC: NLM .