Klofensaid II Side Effects
Generic name: diclofenac topical
Medically reviewed by Drugs.com. Last updated on Apr 23, 2021.
Note: This document contains side effect information about diclofenac topical. Some of the dosage forms listed on this page 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
Topical application route (Patch, Extended Release)
NSAIDs cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use. Diclofenac epolamine is contraindicated in the setting of coronary artery bypass graft surgery. NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.
Topical application route (Gel/Jelly; Solution)
NSAIDs cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use. Diclofenac sodium is contraindicated in the setting of coronary artery bypass graft surgery. NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.
Side effects requiring immediate medical attention
Along with its needed effects, diclofenac topical (the active ingredient contained in Klofensaid II) 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:
- Burning, itching, redness, skin rash, swelling, or soreness at the application site
- itching skin
- Blood in the urine
- chest pain or tightness
- dry, itching, or burning eyes
- eye pain
- headaches, including migraines
- increased sensitivity of the skin to sunlight
- pain or tenderness around the eyes and cheekbones
- redness of the skin
- redness or swelling of the eyes
- runny or stuffy nose
- skin rash other than at the application site
- sore throat
- trouble breathing
- ulcers or sores on the skin, other than at the application site
Incidence not known
- Black, tarry stools
- painful or difficult urination
- sores, ulcers, or white spots on lips or in mouth
- unusual bleeding or bruising
- unusual tiredness or weakness
Side effects not requiring immediate medical attention
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:
- general feeling of discomfort or illness
- joint pain
- loss of appetite
- muscle aches and pains
- scaly, thick, or tingling skin
- trouble sleeping
- back pain
- bleeding skin
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- increase in body movements
- lack or loss of strength
- loss of or change in taste
- loss or thinning of the hair
- neck pain
- sleepiness or unusual drowsiness
- stomach upset or pain
For Healthcare Professionals
Applies to diclofenac topical: topical cream, topical film extended release, topical gel, topical kit, topical solution
The most frequently reported side effects were application site reactions.[Ref]
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]
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]
Common (1% to 10%): Hypertension
Uncommon (0.1% to 1%): Hemorrhage
Postmarketing reports: Palpitation, cardiovascular disorder, blood pressure increased[Ref]
Very rare (less than 0.01%): Gastrointestinal hemorrhage
Frequency not reported: Upper abdominal pain
Common (1% to 10%): Creatinine increased
Very rare (less than 0.01%): Renal failure[Ref]
Common (1% to 10%): SGOT increased, SGPT increased[Ref]
Common (1% to 10%): Hypercholesterolemia, hyperglycemia
Postmarketing reports: Appetite decreased[Ref]
Common (1% to 10%): Back pain, neck pain, arthralgia, arthrosis, myalgia
Postmarketing reports: Leg cramps[Ref]
Common (1% to 10%): Eye pain, conjunctivitis
Uncommon (0.1% to 1%): Lacrimation disorder
Postmarketing reports: Laryngismus, laryngitis[Ref]
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]
Common (1% to 10%): Skin carcinoma[Ref]
Common (1% to 10%): Allergic reaction[Ref]
More about Klofensaid II (diclofenac topical)
- During Pregnancy or Breastfeeding
- Dosage Information
- Drug Interactions
- Drug class: topical non-steroidal anti-inflammatories
Related treatment guides
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. Voltaren Topical (diclofenac topical)." Endo Laboratories LLC, Chadds Ford, PA.
6. "Product Information. Pennsaid (diclofenac topical)." Horizon Pharma USA Inc, Northbrook, IL.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Some side effects may not be reported. You may report them to the FDA.