Diclofenac / Menthol Topical Side Effects

Applies to diclofenac/menthol topical: topical liquid.

Important warnings This medicine can cause some serious health issues

Diclofenac and menthol can increase your risk of fatal heart attack or stroke. Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG). Diclofenac and menthol may also cause stomach or intestinal bleeding, which can be fatal.

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Stop using this medicine and seek emergency medical attention if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, feeling short of breath.

Also call your doctor at once if you have:

• a skin rash, no matter how mild;

• signs of stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;

• kidney problems--little or no urination, swelling in your feet or ankles, feeling tired or short of breath;

• liver problems--nausea, diarrhea, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

• low red blood cells (anemia)--pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet.

Serious side effects may be more likely in older adults.

Common side effects may include:

• skin dryness, redness, itching, or rash;

• blistering or hardening of the treated skin;

• numbness, tingling, burning pain;

• acne;

• flushing (sudden warmth, redness, or tingly feeling);

• stomach pain, constipation, diarrhea, gas, heartburn, nausea, vomiting; or

• dizziness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For healthcare professionals

Applies to diclofenac / menthol topical: topical liquid.

General adverse events

The most common adverse events reported with diclofenac sodium topical solution were application site skin reactions.^[Ref]

Local

• Very common (10% or more): Dry skin (32%)
• Common (1% to 10%): Contact dermatitis (characterized by skin erythema and induration), contact dermatitis with vesicles and pruritus, application site pruritus

Application site reactions were reported as dryness, erythema, induration, vesicles, paresthesia, pruritus, vasodilation, acne, and urticaria.

Hematologic

• Common (1% to 10%): Ecchymosis
• Postmarketing reports: Rectal hemorrhage

Hypersensitivity

• Postmarketing reports: Allergic reaction

Respiratory

• Common (1% to 10%): Pharyngitis, sinusitis
• Postmarketing reports: Asthma, dyspnea, laryngismus, laryngitis

Gastrointestinal

• Common (1% to 10%): Dyspepsia, abdominal pain, flatulence, diarrhea, nausea, constipation, halitosis
• Postmarketing reports: Dry mouth, gastroenteritis, decreased appetite, mouth ulceration, ulcerative stomatitis

Musculoskeletal

• Postmarketing reports: Back pain, leg cramps, myalgia

Metabolic

• Postmarketing reports: Increased creatinine

Dermatologic

• Common (1% to 10%): Rash (non-application site), dry skin (non-application site)
• Postmarketing reports: Face edema, eczema, rash, pruritus, skin discoloration, urticaria

Psychiatric

• Postmarketing reports: Depression

Other

• Postmarketing reports: Asthenia, body odor, pain

Nervous system

• Common (1% to 10%): Paresthesia
• Postmarketing reports: Headache, neck rigidity, dizziness, drowsiness, lethargy

Cardiovascular

• Common (1% to 10%): Edema
• Postmarketing reports: Chest pain, palpitation, cardiovascular disorder

Further information

Diclofenac/menthol topical side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer