Pennsaid Side Effects

Generic name: diclofenac topical

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 Pennsaid.

Some side effects of Pennsaid may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to diclofenac topical: topical film extended release

Get emergency medical help if you have any of these signs of an allergic reaction while taking diclofenac topical (the active ingredient contained in Pennsaid) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Although the risk of serious side effects is low when diclofenac is applied to the skin, you should be aware of side effects that can occur if the medication is absorbed into your bloodstream.

Stop using this medicine and call your doctor at once if you have a serious side effect such as:

• chest pain, slurred speech, problems with vision or balance, and feeling weak or short of breath;

• bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;

• fever, chills, body aches, flu symptoms;

• pale or yellowed skin, dark colored urine, confusion;

• swelling or rapid weight gain;

• urinating less than usual or not at all;

• nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• skin rash, bruising, severe tingling, numbness, pain, muscle weakness;

• fever, sore throat, and headache with a severe blistering, peeling, and red skin rash; or

• the first sign of any skin rash, no matter how mild.

Less serious side effects of diclofenac topical may include:

• mild nausea, vomiting;

• diarrhea, constipation;

• upset stomach, heartburn, gas;

• dizziness; or

• mild itching, burning, redness, or other skin irritation where the patch was worn.

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 topical: topical film extended release, topical gel, topical solution

Local

Local application site reactions have been reported in 75% to 86% of patients and have included rash (35% to 36%), pruritus (31% to 52%), dry skin (25% to 27%), contact dermatitis (19% to 33%), pain (15% to 26%), paresthesia (8% to 20%), exfoliation (6% to 24%), vesiculobullous rash (4%), edema (3% to 4%), hyperesthesia (3%), photosensitivity reaction (3%), acne (1%), alopecia (1% to 2%), erythema (less than 1%), irritation (less than 1%), and papules (less than 1%).

The gel vehicle has also been associated with a high incidence of application site reactions (71% to 86%), including pruritus (45% to 59%), pain (22% to 30%), rash (17% to 20%), dry skin (12% to 17%), exfoliation (4% to 13%), and paresthesia (4% to 20%). Other local reactions have included skin carcinoma, hypertonia, lacrimation disorder, maculopapular rash, purpuric rash, skin hypertrophy, and vasodilation in less than 1% of patients.

Dermatologic

Dermatologic side effects have included pruritus (4%), rash (2% to 4%), dry skin (3%), contact dermatitis (2%), pain (1% to 2%), skin carcinoma (2%), and skin ulcer (1% to 2%). Other dermatologic side effects have included skin hypertrophy, paresthesia, seborrhea, urticaria in less than 1% of patients, and skin discoloration. The gel vehicle has been associated with acne (1% to 2%), herpes simplex (2%), maculopapular rash (2%), and skin nodule (2%).

Cardiovascular

Cardiovascular side effects have included hypertension (1% to 2%), migraine (1%), and palpitation. The gel vehicle has been associated with phlebitis (2%).

Endocrine

Endocrine side effects have included hyperglycemia (greater than 1%).

Gastrointestinal

Gastrointestinal side effects have included dyspepsia (2% to 3%), diarrhea (2%), abdominal pain (1% to 2%), dry mouth, gastroenteritis, mouth ulceration, nausea, rectal hemorrhage, and ulcerative stomatitis. The gel vehicle has been associated with constipation (2%).

Genitourinary

Genitourinary side effects have included hematuria (2%).

Hepatic

Hepatic side effects have included elevations in serum transaminases in up to 15% of patients as well as rare cases of hepatitis, jaundice, and fatal fulminant hepatitis. Liver injury is most likely to occur in older females in the first 6 months of use.

Immunologic

Immunologic side effects have included infection and flu syndrome (greater than 1%).

Metabolic

Metabolic side effects have included increased creatine phosphokinase (4%), increased SGOT (3%), increased SGPT (2%), increased creatinine (2%), hypercholesterolemia (1%), hyperglycemia (1%), and creatinine increased. The gel vehicle has been associated with edema (2%).

Musculoskeletal

Musculoskeletal side effects have included myalgia (2 to 3%), arthralgia (2%), arthrosis (2%), and leg cramps.

Nervous system

Nervous system side effects have included headache (7%), hypokinesia (2%), depression, dizziness, drowsiness, lethargy, paresthesia, and paresthesia at application site. The gel vehicle has been associated with dizziness (4%) and anxiety (1% to 2%).

Ocular

Ocular side effects have included conjunctivitis (2 to 4%) eye pain (2%), blurred or abnormal vision, cataract, and eye disorder.

Respiratory

Respiratory side effects have included asthma, dyspnea, pharyngitis, pneumonia, rhinitis, and sinusitis in 2% of patients.

Renal

Renal side effects have included increased creatinine (2%).

Other

Other side effects have included flu syndrome (1 to 10%), accidental injury (4%), infection (4%), back pain (2 to 4%), asthenia (2%), neck pain (2%), pain (2%), chest pain (1 to 2%), ear pain, and taste perversion.

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