"The US Food and Drug Administration (FDA) has approved 5-aminolevulinic acid (ALA; Ameluz, Biofrontera) gel in combination with the activating BF-RhodoLED photodynamic therapy (PDT) lamp for treatment of patients with actinic keratosis ("...
Synera Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Synera (lidocaine 70 mg and tetracaine 70 mg) Topical Patch contains a local anesthetic used on intact skin to provide local dermal analgesia for superficial venous access and superficial dermatological procedures such as excision, electrodessication and shave biopsy of skin lesions. Common side effects of Synera include localized site reactions such as hives, blanching, swelling, abnormal sensation, rash, or skin discoloration. Systemic side effects of Synera are uncommon but may include:
- ringing in the ears
- blurred or double vision
- sensations of heat or cold
- respiratory depression and arrest
For adults and children 3 years of age and older, apply Synera to intact skin for 20-30 minutes as directed by a physician. Synera may interact with antiarrhythmics, and other topical anesthetics. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant before starting treatment with Synera. Lidocaine passes into breast milk and it is not known if tetracaine passes into breast milk. Consult your doctor before breastfeeding.
Our Synera (lidocaine 70 mg and tetracaine 70 mg) Topical Patch 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.
Synera FDA Prescribing Information: Side Effects
Clinical Studies 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.
Three different formulations were studied during clinical development of SYNERA: Developmental A (n=138), Developmental B (n=30), and the SYNERA final formulation (n=1281). The developmental patch formulations each contained the same amount of the active drug (70 mg each of lidocaine and tetracaine) as the final patch formulation, but varying amounts of excipients, principally polyvinyl alcohol and water. Data obtained from studies utilizing the developmental patches have been included in the overall evaluation of SYNERA safety (calculation of adverse event incidence).
Most common adverse events in clinical trials
During or immediately after treatment with SYNERA, the skin at the site of treatment may develop erythema, blanching, edema, or abnormal sensation. In clinical studies involving 1449 SYNERA-treated subjects, the most common local reactions were erythema (71%), blanching (12%) and edema (12%). These reactions were generally mild, resolving spontaneously soon after patch removal. There were no treatment-related serious adverse events.
Other application site reactions of various types (contact dermatitis, rash, skin discoloration) occurred in less than 4% of SYNERA-treated patients during clinical trials. Of these adverse events, 75% were mild, resolving spontaneously soon after patch removal.
Application site-related adverse events that occurred in 1% or less of SYNERA-treated subjects included rash, pruritus, pain, contact dermatitis, infection, skin discoloration, allergic reaction, blister, paresthesia, urticaria, and vesiculobullous rash.
Allergic or anaphylactoid reactions can occur with the active or inactive components of SYNERA. They may be characterized by urticaria, angioedema, bronchospasm, and shock. Allergic reactions to the patch should be managed by conventional means.
Systemic (Dose-Related) Reactions
Systemic adverse reactions that occurred in 1% or less of SYNERA-treated subjects included dizziness, headache, nausea, somnolence, and vomiting. Systemic adverse effects of lidocaine and tetracaine are similar in nature to those observed with other amide and ester local anesthetic agents, including CNS excitation and/or depression (light-headedness, nervousness, apprehension, euphoria, confusion, dizziness, drowsiness, tinnitus, blurred or double vision, vomiting, sensations of heat, cold or numbness, twitching, tremors, convulsions, unconsciousness, respiratory depression and arrest). Excitatory CNS reactions may be brief or not occur at all, in which case the first manifestation may be drowsiness merging into unconsciousness. Signs of CNS toxicity may start at plasma concentrations of lidocaine as low as 1000 ng/mL. The plasma concentrations at which tetracaine toxicity may occur are less well characterized; however, systemic toxicity with tetracaine is thought to occur with much lower plasma concentrations compared with lidocaine. The toxicity of co-administered local anesthetics is thought to be at least additive. Cardiovascular manifestations may include bradycardia, hypotension and cardiovascular collapse leading to arrest.
Read the entire FDA prescribing information for Synera (Lidocaine and Tetracaine)
Additional Synera Information
- Synera Drug Interactions Center: lidocaine-tetracaine top
- Synera Side Effects Center
- Synera FDA Approved Prescribing Information including Dosage
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.
Find out what women really need.