Applies to diclofenac/menthol topical: topical liquid.

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

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