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ZEMBRACE SYMTOUCH SIDE EFFECTS

  • Generic Name: sumatriptan succinate subcutaneous injection, usp
  • Brand Name: Zembrace-SymTouch
Last updated on MDtodate: 10/11/2022

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
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 .

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