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PENNSAID Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Pennsaid (diclofenac sodium topical solution) is a non-steroidal anti-inflammatory drug (NSAID) used to treat signs and symptoms of osteoarthritis of the knee(s). Common side effects of Pennsaid include:
- skin irritation (e.g., dryness, redness, stinging, itching, scaling, hives, swelling),
- stomach pain,
- upset stomach,
- urinary tract infection,
- stuffy nose,
- sore throat,
- rash (non-application site),
- numbness and tingling,
- bad breath, and
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 breastfeeding.
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.
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
The following adverse reactions are discussed in greater detail in other sections of the labeling:
- Cardiovascular Thrombotic Events [see WARNINGS AND PRECAUTIONS]
- GI Bleeding, Ulceration and Perforation [see WARNINGS AND PRECAUTIONS]
- Hepatotoxicity [see WARNINGS AND PRECAUTIONS]
- Hypertension [see WARNINGS AND PRECAUTIONS]
- Heart Failure and Edema [see WARNINGS AND PRECAUTIONS]
- Renal Toxicity and Hyperkalemia [see WARNINGS AND PRECAUTIONS]
- Anaphylactic Reactions [see WARNINGS AND PRECAUTIONS]
- Serious Skin Reactions [see WARNINGS AND PRECAUTIONS]
- Hematologic Toxicity [see WARNINGS AND PRECAUTIONS]
Clinical Trials 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.
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)
|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%)|
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%
|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)|
|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)|
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.
Cardiovascular: palpitation, cardiovascular disorder
Metabolic and Nutritional: creatinine increased
Musculoskeletal: leg cramps, myalgia
Nervous: depression, dizziness, drowsiness, lethargy, paresthesia at application site
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)
Additional PENNSAID Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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