What are the most common side effects of LIDOCAINE HCL AND HYDROCORTISONE ACETATE?

Reported side effects vary by individual. The side-effects section on this page lists the events most frequently reported to FDA FAERS for LIDOCAINE HCL AND HYDROCORTISONE ACETATE. FAERS is voluntary reporting, so it reflects what was reported, not absolute incidence.

Is LIDOCAINE HCL AND HYDROCORTISONE ACETATE the same as its brand-name version?

LIDOCAINE HCL AND HYDROCORTISONE ACETATE is the generic name. The active ingredient is the same across any brand-name or generic versions approved by the FDA.

LIDOCAINE HCL AND HYDROCORTISONE ACETATE

Q: What is LIDOCAINE HCL AND HYDROCORTISONE ACETATE used for?

LIDOCAINE HCL AND HYDROCORTISONE ACETATE is a Other indicated for INDICATIONS: Product is used for the anti-inflammatory and anesthetic relief of itching, pain, soreness and discomfort due to hemorrhoids.

Q: How does LIDOCAINE HCL AND HYDROCORTISONE ACETATE work?

LIDOCAINE HCL AND HYDROCORTISONE ACETATE works through the following mechanism: MECHANISM OF ACTION: Product releases lidocaine to stabilize the neuronal membrane by inhibiting the ionic fluxes required for initiation and conduction of impulses, thereby effecting local anesthetic action. Hydrocortisone acetate provides relief of inflammatory and pruritic manifestations of corticosteroid responsive dermatoses..

Other

Pregnancy: Category CRectal

Mechanism of Action

MECHANISM OF ACTION: Product releases lidocaine to stabilize the neuronal membrane by inhibiting the ionic fluxes required for initiation and conduction of impulses, thereby effecting local anesthetic action. Hydrocortisone acetate provides relief of inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.

Indications

INDICATIONS: Product is used for the anti-inflammatory and anesthetic relief of itching

pain

soreness and discomfort due to hemorrhoids

anal fissures

pruritus ani and similar conditions of the anal area.

Contraindications

• CONTRAINDICATIONS: Product should not be used in patients with a history of sensitivity to any of its ingredients or adverse reactions to lidocaine or amide anesthetics
• which usually do not cross-react with “caine” ester type anesthetics. If excessive irritation and significant worsening occur
• discontinue use and seek the advice of your physician. Product and topical lidocaine should be used cautiously in those with impaired liver function
• varicella and acute herpes simplex. Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

FDA Warnings

Product should not come into contact with the eye or be applied into the eye because of the risk of severe eye irritation and the loss of eye surface sensation, which reduces protective reflexes and can lead to corneal irritation and possibly abrasion

Known Side Effects

9 documented side effects by frequency

Drug Not Working

>10%

Nausea

1-10%

Fatigue

1-10%

Headache

1-10%

Shortness of Breath

1-10%

Condition Worsened

0.1-1%

Diarrhea

0.1-1%

Vomiting

0.1-1%

Dizziness

0.1-1%

Community Discussions

No community discussions found for LIDOCAINE HCL AND HYDROCORTISONE ACETATE yet.

Primary sources

Every figure on this page links back to its primary source. See data sources for full provenance.

DailyMed FDA label search → LIDOCAINE HCL AND HYDROCORTISONE ACETATE openFDA label JSON → LIDOCAINE HCL AND HYDROCORTISONE ACETATE FAERS adverse-event reports → LIDOCAINE HCL AND HYDROCORTISONE ACETATE ClinicalTrials.gov → completed Phase 2+ trials of LIDOCAINE HCL AND HYDROCORTISONE ACETATE

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Formulations

Dosage Forms

Tablet

Route

Rectal