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PENNSAID

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PENNSAID

PENNSAID Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Pennsaid (diclofenac sodium topical solution) is used for the treatment of signs and symptoms of osteoarthritis of the knee(s). It is a non-steroidal anti-inflammatory drug (NSAID). Common side effects include skin irritation (e.g., dryness, redness, stinging), drowsiness, or dizziness.

The recommended dose of Pennsaid is 40 drops per knee, 4 times a day, applied to clean, dry skin. Pennsaid may interact with anti-platelet drugs, blood thinners, cidofovir, corticosteroids, cyclosporine, desmopressin, digoxin, high blood pressure drugs, lithium, methotrexate, probenecid, SSRI antidepressants, and diuretics (water pills). Tell your doctor all medications you are taking. Pennsaid should be used only when prescribed during the first 6 months of pregnancy. It is not recommended for use during the last 3 months of pregnancy due to possible harm to the fetus. Based on information from related drugs, this medication may pass into breast milk. Though there have been no reports of harm to nursing infants, consult your doctor before breast-feeding.

Our Pennsaid Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

PENNSAID in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: 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;
  • 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);
  • 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 may include:

  • mild nausea, stomach pain, upset stomach;
  • diarrhea, gas; or
  • mild itching, dryness, redness, scaling, or other skin irritation where the medicine was applied.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for PENNSAID (Diclofenac Sodium Topical Solution) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

PENNSAID FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Clinical Studies Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Pennsaid

The data described below reflect exposure to PENNSAID of 130 patients treated for 4 weeks (mean duration of 28 days) in one Phase 2 controlled trial. This population's mean age was approximately 60 years, 85% of patients were Caucasian, 65% were females, and all patients had primary osteoarthritis. The most common adverse events with PENNSAID were application site skin reactions. These events were the most common reason for withdrawing from the study.

Application site reactions

In this controlled trial, application site reactions were characterized by one or more of the following: dryness (22%), exfoliation (7%), erythema (4%), pruritus (2%), pain (2%), induration (2%), rash (2%), and scabbing ( < 1%).

Other Common Adverse Reactions

Table 1 lists all adverse reactions occurring in > 1% of patients receiving PENNSAID, where the rate in the PENNSAID group exceeded vehicle, from a controlled study conducted in patients with osteoarthritis.

Table 1: Incidence of Adverse Reactions Occurring in > 1% of Subjects with Osteoarthritis Using PENNSAID and More Often than in Subjects with OA Using Vehicle Control (Pooled)

Adverse Reaction PENNSAID
N=130
n (%)
Vehicle Control
N=129
n (%)
Urinary tract infection 4 (3%) 1 ( < 1%)
Application site induration 2 (2%) 1 ( < 1%)
Contusion 2 (2%) 1 ( < 1%)
Sinus congestion 2 (2%) 1 ( < 1%)
Nausea 2 (2%) 0

Pennsaid 1.5%

The safety of PENNSAID 2% is based in part, on prior experience with PENNSAID 1.5%. The data described below reflect exposure to PENNSAID 1.5% of 911 patients treated between 4 and 12 weeks (mean duration of 49 days) in seven Phase 3 controlled trials, as well as exposure of 793 patients treated in an open-label study, including 463 patients treated for at least 6 months, and 144 patients treated for at least 12 months. The population mean age was approximately 60 years, 89% of patients were Caucasian, 64% were females, and all patients had primary osteoarthritis. The most common adverse events with PENNSAID 1.5% were application site skin reactions. These events were the most common reason for withdrawing from the studies.

Application site reactions

In controlled trials, application site reactions were characterized by one or more of the following: dryness, erythema, induration, vesicles, paresthesia, pruritus, vasodilation, acne, and urticaria. The most frequent of these reactions were dry skin (32%), contact dermatitis characterized by skin erythema and induration (9%), contact dermatitis with vesicles (2%) and pruritus (4%). In one controlled trial, a higher rate of contact dermatitis with vesicles (4%) was observed after treatment of 152 subjects with the combination of PENNSAID 1.5% and oral diclofenac. In the open label uncontrolled long-term safety study, contact dermatitis occurred in 13% and contact dermatitis with vesicles in 10% of patients, generally within the first 6 months of exposure, leading to a withdrawal rate for an application site event of 14%.

Other Common Adverse Reactions

In controlled trials, subjects treated with PENNSAID 1.5% experienced some adverse events associated with the NSAID class more frequently than subjects using placebo (constipation, diarrhea, dyspepsia, nausea, flatulence, abdominal pain, edema; see Table 2). The combination of PENNSAID 1.5% and oral diclofenac, compared to oral diclofenac alone, resulted in a higher rate of rectal hemorrhage (3% vs. less than 1%), and more frequent abnormal creatinine (12% vs. 7%), urea (20% vs. 12%), and hemoglobin (13% vs. 9%), but no difference in elevation of liver transaminases.

Table 2 lists all adverse reactions occurring in ≥ 1% of patients receiving PENNSAID 1.5%, where the rate in the PENNSAID 1.5% group exceeded placebo, from seven controlled studies conducted in patients with osteoarthritis. Since these trials were of different durations, these percentages do not capture cumulative rates of occurrence.

Table 2: Adverse Reactions Occurring in ≥ 1% of Patients Treated with PENNSAID 1.5% Topical Solution in Placebo and Oral Diclofenac-Controlled Trials

Treatment Group: PENNSAID 1.5%
N=911
Topical Placebo
N=332
Adverse Reaction N (%) N (%)
Dry Skin (Application Site) 292 (32) 17 (5)
Contact Dermatitis (Application Site) 83 (9) 6 (2)
Dyspepsia 72 (8) 13 (4)
Abdominal Pain 54 (6) 10 (3)
Flatulence 35 (4) 1 ( < 1)
Pruritus (Application Site) 34 (4) 7 (2)
Diarrhea 33 (4) 7 (2)
Nausea 33 (4) 3 (1)
Pharyngitis 40 (4) 13 (4)
Constipation 29 (3) 1 ( < 1)
Edema 26 (3) 0
Rash (Non-Application Site) 25 (3) 5 (2)
Infection 25 (3) 8 (2)
Ecchymosis 19 (2) 1 ( < 1)
Dry Skin (Non-Application Site) 19 (2) 1 ( < 1)
Contact Dermatitis, vesicles (Application Site) 18 (2) 0
Paresthesia (Non-Application Site) 14 (2) 3 ( < 1)
Accidental Injury 22 (2) 7 (2)
Pruritus (Non-Application Site) 15 (2) 2 ( < 1)
Sinusitis 10 (1) 2 ( < 1)
Halitosis 11 (1) 1 ( < 1)
Application Site Reaction (not otherwise specified) 11 (1) 3 ( < 1)

Postmarketing Experience

In postmarketing surveillance, the following adverse reactions have been reported during post-approval use of PENNSAID 1.5%. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Body as a Whole: abdominal pain, accidental injury, allergic reactions, asthenia, back pain, body odor, chest pain, edema, face edema, halitosis, headache, neck rigidity, pain

Cardiovascular: palpitation, cardiovascular disorder

Gastrointestinal: diarrhea, dry mouth, dyspepsia, gastroenteritis, decreased appetite, lip swelling, mouth ulceration, nausea, rectal hemorrhage, ulcerative stomatitis, swollen tongue

Metabolic and Nutritional: creatinine increased

Musculoskeletal: leg cramps, myalgia

Nervous: depression, dizziness, drowsiness, lethargy, paresthesia at application site

Respiratory: asthma, dyspnea, laryngismus, laryngitis, pharyngitis, throat swelling

Skin and Appendages: At the Application Site: rash, skin burning sensation;

Other Skin and Appendages Adverse Reactions: eczema, skin discoloration, urticaria

Special Senses: abnormal vision, blurred vision, cataract, ear pain, eye disorder, eye pain, taste perversion

Vascular: blood pressure increased, hypertension

Read the entire FDA prescribing information for PENNSAID (Diclofenac Sodium Topical Solution) »

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