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Zingo Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Zingo (lidocaine hydrochloride monohydrate) is a local anesthetic used on intact skin to provide topical local analgesia prior to venipuncture or peripheral intravenous cannulation. The brand name Zingo is discontinued, but generic versions may be available. Common side effects of Zingo (lidocaine hydrochloride monohydrate) include:
- application site reactions (such as redness, broken blood vessels, swelling, itching, pain, bruising, burning, numbness)
- nausea, and
Apply one Zingo to the site planned for venipuncture or intravenous cannulation, one to three minutes prior to needle insertion. Zingo may interact with other drugs. Tell your doctor all medications and supplements you use. During pregnancy, Zingo should only be used if prescribed. Tell your doctor if you are pregnant before receiving Zingo. This drug passes into breast milk. Consult your doctor before breastfeeding.
Our Zingo (lidocaine hydrochloride monohydrate) 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.
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Zingo FDA Prescribing Information: Side Effects
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 to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
The safety of ZINGO® has been evaluated in 10 clinical trials, five in adults and five in pediatric patients.
The five adult clinical trials consisted of a randomized, double-blind, parallel-arm, sham-placebo controlled Phase 3 trial that enrolled 693 patients, two randomized, double-blind, crossover design, sham-placebo controlled Phase 1 trials that enrolled 455 patients, and two open -label studies that enrolled 44 patients. A total of 742 adults received an active treatment with an active treatment that delivered a 0.5 mg dose of lidocaine, while 755 received placebo.
The five pediatric clinical trials consisted of five randomized, double-blind, parallel-arm, shamplacebo controlled trials in which 1761 patients, ages 3 to 18, received either ZINGO® or a sham placebo device. A total of 906 pediatric patients received active treatment, while 855 received placebo.
Application Site Reaction
In adults, erythema occurred in 67.3% of ZINGO® treated patients, and in 25.0% of placebo-treated patients. Petechiae occurred in 46.4% of ZINGO® treated patients, and in 7.0% of placebo-treated patients. Edema occurred in 4.3% of patients ZINGO® treated patients, and in 0.8% placebo-treated patients. Pruritus occurred in 9.4% of treated patients and in 6.2% of placebo-treated patients. In pediatric patients, erythema occurred in 53% of ZINGO® treated patients, and in 27%of placebo-treated patients. Petechiae occurred in 44% of ZINGO® treated patients, and in 5% of placebo-treated patients. Edema occurred in 8% of ZINGO® treated patients, and in 3% of placebo treated patients. Pruritus occurred in 1% of patients in both treatment groups.
Amongst the 742 adult patients receiving active treatment and 775 adults patients receiving sham placebo treatment in the 5 adult studies, the percentage of adult patients with any adverse reactions was 3.9% in the active-treated patients and 4.9% in the sham placebo treated patients.
Most adverse reactions were application-site related (i.e., hypoaesthesia (0% active, 0.5% sham placebo), burning (0.54% active, 0.4% sham placebo), and venipuncture site hemorrhage (0.4% active, 1.7% sham placebo)).
The most common systemic adverse reaction was dizziness, which occurred in 0.9% of active treated adult patients and in 0.7% of sham placebo treated adult patients. No other systemic adverse events occurred in more than two patients in either treatment group.
Amongst the 906 pediatric patients receiving active treatment and 855 pediatric patients receiving sham placebo treatment, the percentage of pediatric patients with any adverse reactions was approximately 9% in each treatment group.
Most adverse reactions were application-site related (i.e. bruising, burning, pain, contusion, hemorrhage), occurring in 4% of pediatric patients in each treatment group. The most common systemic adverse reactions were nausea (2%) and vomiting (1%).
Read the entire FDA prescribing information for Zingo (Lidocaine Hydrochloride Monohydrate)
Additional Zingo Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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