SIDE EFFECTS:

Dizziness, nausea, nervousness, unusual feelings of well-being, or restlessness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: fever, mental/mood changes (e.g., drowsiness, confusion, hallucinations, mood swings), numbness in application area several hours after procedure, loss of smell or taste, vision problems (e.g., blurred vision, sensitivity to light).

Tell your doctor immediately if any of these rare but very serious side effects occur: slow/shallow/rapid breathing, fainting, fast/slow/irregular/pounding heartbeat, severe headache, shaking (tremors).

Seek immediate medical attention if any of these rare but very serious side effects occur: chest pain, seizures.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the Cocaine (cocaine hydrochloride topical solution) Side Effects Center for a complete guide to possible side effects

PRECAUTIONS: Before your procedure, tell your doctor or pharmacist if you are allergic to cocaine; or to other ester-type anesthetics (e.g., benzocaine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: high blood pressure, heart disease (e.g., chest pain, heart attack, irregular heartbeat), overactive thyroid (hyperthyroidism), seizures, infection/sores/injury in the area of the application site (e.g., mouth, nose, throat).

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.

Caution is advised when using this drug in children because they may be more sensitive to the effects of the drug, especially restlessness/excitement.

Caution is advised when using this drug in the elderly because they may be more sensitive to the effects of the drug, especially irregular heartbeat and chest pain.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This drug may pass into breast milk and could have undesirable effects on a nursing infant. Therefore, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.