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Klofensaid II Side Effects

Generic Name: diclofenac topical

Note: This page contains information about the side effects of diclofenac topical. Some of the dosage forms included on this document may not apply to the brand name Klofensaid II.

For the Consumer

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

In addition to its needed effects, some unwanted effects may be caused by diclofenac topical (the active ingredient contained in Klofensaid II). In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when taking diclofenac topical:

More common:
  • Application site reactions, including skin rash, pain, tingling, or burning sensation
  • flu-like syndrome (body ache, headache, fever, with or without chills)
  • itching skin
Less common or rare:
  • Blood in the urine
  • cough
  • dry, itching, or burning eyes
  • eye pain
  • headaches, including migraines
  • increased sensitivity of the skin
  • nasal congestion
  • pain or tenderness around the eyes and cheekbones
  • redness of the skin
  • redness or swelling of the eyes
  • skin rash other than at the application site
  • sore throat
  • tightness in the chest
  • troubled breathing
  • ulcers or sores on the skin, other than at the application site

Minor Side Effects

Some of the side effects that can occur with diclofenac topical may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common:
  • Burning skin
  • dry skin
  • scaly skin
  • thickened skin
  • tingling skin
Less common:
  • Acne
  • back pain
  • belching
  • bleeding skin
  • chest pain
  • diarrhea
  • heartburn
  • indigestion
  • joint pain
  • lack or loss of strength
  • loss or thinning of the hair
  • muscle pain
  • neck pain
  • runny nose
  • stomach upset or pain

For Healthcare Professionals

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

General

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]

References

1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

2. Cerner Multum, Inc. "Australian Product Information." O 0

3. "Product Information. Flector Patch (diclofenac topical)." Actavis U.S. (Alpharma USPD), Owings Mills, MD.

4. "Product Information. Solaraze (diclofenac topical)" SkyePharma, San Diego, CA.

5. "Product Information. Pennsaid (diclofenac topical)." Horizon Pharma USA Inc, Northbrook, IL.

6. "Product Information. Voltaren Topical (diclofenac topical)." Endo Laboratories LLC, Chadds Ford, PA.

Not all side effects for Klofensaid II may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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