Profinac Side Effects

Generic name: diclofenac topical

Medically reviewed by Drugs.com. Last updated on Jan 19, 2025.

Note: This document provides detailed information about Profinac Side Effects associated with diclofenac topical. Some dosage forms listed on this page may not apply specifically to the brand name Profinac.

Applies to diclofenac topical: topical application cream, topical application gel/jelly, topical application patch extended release, topical application solution, topical application spray.

Serious side effects of Profinac

Along with its needed effects, diclofenac topical (the active ingredient contained in Profinac) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking diclofenac topical:

Other side effects of Profinac

Some side effects of diclofenac topical may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Precautions

It is very important that your doctor check your or your child's progress at regular visits. This will allow your doctor to make sure this medicine is working properly and to decide if you should continue to use it. Blood and urine tests may be needed to check for unwanted effects.

This medicine may increase your risk of having a heart attack or stroke. This is more likely in people who already have heart disease or in people who use this medicine for a long time.

This medicine may cause bleeding in your stomach or bowels. These problems can happen without warning signs. This is more likely if you have had a stomach ulcer in the past, if you smoke or drink alcohol regularly, are over 60 years of age, are in poor health, or are using certain other medicines (eg, other NSAIDs, steroid medicine, blood thinners).

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Serious skin reactions, including Stevens-Johnson syndrome, exfoliative dermatitis, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS) can occur during treatment with this medicine. Check with your doctor right away if you have black, tarry stools, blistering, peeling, or loosening of the skin, chest pain, chills, cough, diarrhea, fever, itching, joint or muscle pain, painful or difficult urination, red irritated eyes, red skin lesions, sore throat, sores, ulcers, or white spots in the mouth or on the lips, swollen glands, unusual bleeding or bruising, or unusual tiredness or weakness.

Some possible warning signs of serious side effects that can occur during treatment with this medicine may include black, tarry stools, decreased urination, severe stomach pain, skin rash, swelling of the face, fingers, feet, or lower legs, unusual bleeding or bruising, unusual weight gain, vomiting of blood or material that looks like coffee grounds, or yellow skin or eyes. Also, signs of serious heart problems could occur including chest pain or tightness, fast or irregular heartbeat, unusual flushing or warmth of skin, weakness, or slurring of speech. Check with your doctor right away if you notice any of these warning signs.

Check with your doctor right away if you have bloody urine, a decrease in frequency or amount of urine, an increase in blood pressure, increased thirst, loss of appetite, lower back or side pain, nausea, swelling of the face, fingers, or lower legs, trouble breathing, unusual tiredness or weakness, vomiting, or weight gain. These could be symptoms of a serious kidney problem.

Hyperkalemia (high potassium in the blood) may occur while you are using this medicine. Check with your doctor right away if you have stomach pain, confusion, difficulty with breathing, irregular heartbeat, nausea or vomiting, nervousness, numbness or tingling in the hands, feet, or lips, or weakness or heaviness of the legs.

This medicine may cause a serious allergic reaction called anaphylaxis, which can be life-threatening and requires immediate medical attention. It may occur often in patients who are allergic to aspirin or other nonsteroidal anti-inflammatory drugs. Call your doctor right away if you have a rash, itching, trouble breathing or swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

Using this medicine during the later part of pregnancy can harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away.

If your symptoms become worse, check with your doctor.

Diclofenac may cause redness, soreness, scaling, and peeling of the affected skin. Do not stop using this medicine without first checking with your doctor. If the reaction is very uncomfortable, check with your doctor.

While using this medicine, your skin may become more sensitive to sunlight than usual, and too much sunlight may increase the effects of the medicine. During this period of time:

• Stay out of direct sunlight, especially between the hours of 10 AM and 3 PM, if possible.
• Wear protective clothing, including a hat and sunglasses.
• Do not use a sunlamp or tanning bed or booth.
• Make sure you have discussed the use of a sun block product with your doctor.

If you have a severe reaction from the sun, check with your doctor.

This medicine may cause a delay in ovulation for women and may affect their ability to have children. If you plan to have children, talk with your doctor before using this medicine.

Before having any kind of surgery or medical tests, tell your doctor that you are using this medicine. It may be necessary for you to stop treatment for awhile, or to change to a different nonsteroidal antiinflammatory drug before your procedure.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

For healthcare professionals

Applies to diclofenac topical: topical cream, topical film extended release, topical gel, topical kit, topical solution.

General adverse events

The most frequently reported side effects were application site reactions.^[Ref]

Local

• Very common (10% or more): Dryness (up to 32%)
• Common (1% to 10%): Dermatitis, burning sensation, pruritus, exfoliation, erythema, pain, induration, rash, scabbing, contusion, inflammation, irritation, itching, tingling, blistering, localized paresthesia
• Frequency not reported: Vesicles, papules, localized hair discoloration, vasodilation, purpuric rash, atrophy^[Ref]

Dermatologic

• Common (1% to 10%): Contact dermatitis, eczema, dry skin, rash, scaly rash, skin hypertrophy, skin ulcer, vesiculobullous rash, exfoliation, urticaria, acne, alopecia, skin nodule
• Uncommon (0.1% to 1%): Face edema, maculopapular rash, photosensitivity reaction, seborrhea
• Rare (0.01% to 0.1%): Bullous dermatitis
• Very rare (less than 0.01%): Pustular rash
• Frequency not reported: Skin hypertrophy^[Ref]

Cardiovascular

• Common (1% to 10%): Hypertension
• Uncommon (0.1% to 1%): Hemorrhage
• Postmarketing reports: Palpitation, cardiovascular disorder, blood pressure increased^[Ref]

Gastrointestinal

• Common (1% to 10%): Abdominal pain, diarrhea, dyspepsia, halitosis, nausea, flatulence, constipation
• Very rare (less than 0.01%): Gastrointestinal hemorrhage
• Frequency not reported: Upper abdominal pain
• Postmarketing reports: Dry mouth, gastroenteritis, mouth ulceration, rectal hemorrhage, ulcerative stomatitis, lip swelling, swollen tongue^[Ref]

Nervous system

• Common (1% to 10%): Headache, migraine, hypokinesia, dysgeusia, somnolence, hypertonia, hyperesthesia, paresthesia
• Postmarketing reports: Dizziness, drowsiness, lethargy, taste perversion^[Ref]

Renal

• Common (1% to 10%): Creatinine increased
• Very rare (less than 0.01%): Renal failure^[Ref]

Hepatic

• Common (1% to 10%): SGOT increased, SGPT increased^[Ref]

Metabolic

• Common (1% to 10%): Hypercholesterolemia, hyperglycemia
• Postmarketing reports: Appetite decreased^[Ref]

Musculoskeletal

• Common (1% to 10%): Back pain, neck pain, arthralgia, arthrosis, myalgia
• Postmarketing reports: Leg cramps^[Ref]

Ocular

• Common (1% to 10%): Eye pain, conjunctivitis
• Uncommon (0.1% to 1%): Lacrimation disorder
• Postmarketing reports: Abnormal vision, blurred vision, cataract, eye disorder^[Ref]

Respiratory

• Common (1% to 10%): Asthma, dyspnea, pharyngitis, pneumonia, rhinitis, sinusitis, sinus congestion
• Postmarketing reports: Laryngismus, laryngitis^[Ref]

Other

• Common (1% to 10%): Accidental injury, asthenia, chest pain, flu-like syndrome, infection, pain, creatine phosphokinase increased, edema
• Postmarketing reports: Lack of drug effect, body odor, ear pain^[Ref]

Oncologic

• Common (1% to 10%): Skin carcinoma^[Ref]

Genitourinary

• Common (1% to 10%): Hematuria, urinary tract infection^[Ref]

Immunologic

• Common (1% to 10%): Allergic reaction^[Ref]

Psychiatric

• Postmarketing reports: Depression^[Ref]

See also:

Further information

Profinac 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