Pennsaid (diclofenac sodium) for Arthritis: Side Effects & Warnings

Generic drug: diclofenac sodium

Brand name: Pennsaid

What is Pennsaid (diclofenac sodium), and how does it work?

Pennsaid (diclofenac sodium) is a topical non-steroidal anti-inflammatory drug (NSAID) used to treat the symptoms of Acute Pain, Arthritis Pain, Actinic Keratosis, and Osteoarthritis. Pennsaid may be used alone or with other medications.

Pennsaid belongs to a class of drugs called Topical Skin Products.

It is not known if Pennsaid is safe and effective in children younger than 6 years of age.

What are the side effects of Pennsaid?

WARNING

RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS

Cardiovascular Thrombotic Events

• Nonsteroidal anti-inflammatory drugs (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.
• Pennsaid is contraindicated in the setting of coronary artery bypass
  graft (CABG) surgery.

Gastrointestinal Bleeding, Ulceration, and Perforation

• 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.

Pennsaid may cause serious side effects including:

• hives,
• sneezing,
• runny or stuffy nose,
• wheezing,
• trouble breathing,
• swelling in your face or throat,
• fever,
• sore throat,
• burning eyes,
• skin pain,
• red or purple skin rash with blistering and peeling,
• chest pain spreading to your jaw or shoulder,
• sudden numbness or weakness on one side of the body,
• slurred speech,
• shortness of breath,
• first sign of any skin rash (no matter how mild),
• swelling,
• rapid weight gain,
• severe headache,
• blurred vision,
• pounding in your neck or ears,
• little or no urination,
• nausea,
• diarrhea,
• stomach pain (upper right side),
• tiredness,
• itching,
• dark urine,
• clay-colored stools,
• yellowing of the skin or eyes (jaundice),
• pale skin,
• unusual tiredness,
• lightheadedness,
• cold hands and feet,
• bloody or tarry stools,
• coughing up blood, and
• vomit that looks like coffee grounds

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of Pennsaid include:

• heartburn,
• gas,
• stomach pain,
• nausea,
• vomiting,
• diarrhea,
• constipation,
• headache,
• dizziness,
• drowsiness,
• stuffy nose,
• itching,
• increased sweating,
• increased blood pressure, and
• skin redness, itching, dryness, scaling, or peeling where the medicine was applied

Tell the doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Pennsaid. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the dosage for Pennsaid?

General Dosing Instructions

Use the lowest effective dosage for the shortest duration consistent with
individual patient treatment goals.

For relief of the pain of osteoarthritis (OA) of the knee(s), the recommended dose is 40 mg of diclofenac sodium (2 pump actuations) on each painful knee, 2 times a day.

Apply Pennsaid to clean, dry skin.

The pump must be primed before first use. Instruct patients to fully depress the pump mechanism (actuation) 4 times while holding the bottle in an upright position. This portion should be discarded to ensure proper priming of the pump. No further priming of the bottle should be required.

After the priming procedure, Pennsaid is properly dispensed by completely depressing the pump 2 times to achieve the prescribed dosage for one knee. Deliver the product directly into the palm of the hand and then apply evenly around front, back, and sides of the knee.

Application of Pennsaid in an amount exceeding or less than the recommended dose has not been studied and is therefore not recommended.

Special Precautions

• Avoid showering/bathing for at least 30 minutes after the application of
  Pennsaid to the treated knee.
• Wash and dry hands after use.
• Do not apply Pennsaid to open wounds.
• Avoid contact of Pennsaid with eyes and mucous membranes.
• Do not apply external heat and/or occlusive dressings to treated knees.
• Avoid wearing clothing over the Pennsaid-treated knee(s) until the treated knee is dry.
• Protect the treated knee(s) from natural and artificial sunlight.
• Wait until the treated area is dry before applying sunscreen, insect repellant, lotion, moisturizer, cosmetics, or other topical medication to the same knee you have just treated with
  Pennsaid.
• Until the treated knee(s) is completely dry, avoid skin-to-skin contact between other people and the treated knee(s).
• Do not use combination therapy with Pennsaid and an oral NSAID unless the benefit outweighs the risk and conduct periodic laboratory evaluations.

The term arthritis refers to stiffness in the joints.
See Answer

What drugs interact with Pennsaid?

See Table 3 for clinically significant drug interactions with diclofenac.

Table 3: Clinically Significant Drug Interactions with Diclofenac

Drugs That Interfere with Hemostasis

Clinical Impact:

• Diclofenac and anticoagulants such as warfarin have a synergistic effect on bleeding. The concomitant use of diclofenac and anticoagulants have increased the risk of serious bleeding compared to the use of either drug alone.
• Serotonin release by platelets plays an important role in hemostasis. Case-control and cohort epidemiological studies showed that concomitant use of drugs that interfere with serotonin reuptake and an NSAID may potentiate the risk of bleeding more than an NSAID alone.

Intervention:
Monitor patients with concomitant use of Pennsaid with
anticoagulants (e.g., warfarin), antiplatelet agents (e.g.,
aspirin), selective serotonin reuptake inhibitors (SSRIs), and
serotonin norepinephrine reuptake inhibitors (SNRIs) for signs of
bleeding

Aspirin

Clinical Impact:
Controlled clinical studies showed that the concomitant use of
NSAIDs and analgesic doses of aspirin does not produce any greater
therapeutic effect than the use of NSAIDs alone. In a clinical
study, the concomitant use of an NSAID and aspirin was associated
with a significantly increased incidence of GI adverse reactions as
compared to use of the NSAID alone

Intervention:
Concomitant use of Pennsaid and analgesic doses of aspirin is
not generally recommended because of the increased risk of bleeding.

Pennsaid is not a substitute for low dose aspirin for cardiovascular protection.

ACE Inhibitors, Angiotensin Receptor Blockers, and Beta-Blockers

Clinical Impact:

• NSAIDs may diminish the antihypertensive effect of angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), or beta-blockers (including propranolol).
• In patients who are elderly, volume-depleted (including those on diuretic therapy), or have renal impairment, co-administration of an NSAID with ACE inhibitors or ARBs may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible.

Intervention:

• During concomitant use of Pennsaid and ACE-inhibitors, ARBs, or beta-blockers, monitor blood pressure to ensure that the desired blood pressure is obtained.
• During concomitant use of Pennsaid and ACE-inhibitors or
  ARBs in patients who are elderly, volumedepleted, or have
  impaired renal function, monitor for signs of worsening renal
  function.
• When these drugs are administered concomitantly, patients should be adequately hydrated. Assess renal function at the beginning of the concomitant treatment and periodically thereafter.

Diuretics

Clinical Impact:
Clinical studies, as well as post-marketing observations, showed that NSAIDs reduced the natriuretic effect of loop diuretics (e.g., furosemide) and thiazide diuretics in some patients. This effect has been attributed to the NSAID inhibition of renal prostaglandin synthesis.

Intervention:
During concomitant use of Pennsaid with diuretics, observe
patients for signs of worsening renal function, in addition to
assuring diuretic efficacy including antihypertensive effects.

Digoxin

Clinical Impact:
The concomitant use of diclofenac with digoxin has been reported to increase the serum concentration and prolong the half-life of digoxin.

Intervention:
During concomitant use of Pennsaid and digoxin, monitor serum digoxin levels.

Lithium

Clinical Impact:
NSAIDs have produced elevations in plasma lithium levels and reductions in renal lithium clearance. The mean minimum lithium concentration increased 15%, and the renal clearance decreased by approximately 20%. This effect has been attributed to NSAID inhibition of renal prostaglandin synthesis.

Intervention:
During concomitant use of Pennsaid and lithium, monitor patients for signs of lithium toxicity.

Methotrexate

Clinical Impact:
Concomitant use of NSAIDs and methotrexate may increase the risk for methotrexate toxicity (e.g., neutropenia, thrombocytopenia, renal dysfunction)

Intervention:
During concomitant use of Pennsaid and methotrexate, monitor patients for methotrexate toxicity.

Cyclosporine

Clinical Impact:
Concomitant use of Pennsaid and cyclosporine may increase cyclosporine's nephrotoxicity.

Intervention:
During concomitant use of Pennsaid and cyclosporine, monitor patients for signs of worsening renal function.

NSAIDs and Salicylates

Clinical Impact:
Concomitant use of diclofenac with other NSAIDs or salicylates
(e.g., diflunisal, salsalate) increases the risk of GI toxicity,
with little or no increase in efficacy.

Concomitant use of oral NSAIDs with Pennsaid has been evaluated in one Phase 3 controlled trial and in combination with 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%).

Intervention:
The concomitant use of diclofenac with other NSAIDs or salicylates is not recommended.

Do not use combination therapy with Pennsaid and an oral NSAID unless the benefit outweighs the risk and conduct periodic laboratory evaluations.

Pemetrexed

Clinical Impact:
Concomitant use of Pennsaid and pemetrexed may increase the risk of pemetrexed-associated myelosuppression, renal, and GI toxicity (see the pemetrexed prescribing information).

Intervention:
During concomitant use of Pennsaid and pemetrexed, in patients with renal impairment whose creatinine clearance ranges from 45 to 79 mL/min, monitor for myelosuppression, renal and GI toxicity.

NSAIDs with short elimination half-lives (e.g., diclofenac, indomethacin) should be avoided for a period of two days before, the day of, and two days following administration of pemetrexed.

In the absence of data regarding potential interaction between pemetrexed and NSAIDs with longer half-lives (e.g., meloxicam, nabumetone), patients taking these NSAIDs should interrupt dosing for at least five days before, the day of, and two days following pemetrexed administration.

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Is Pennsaid safe to use while pregnant or breastfeeding?

• Use of NSAIDs, including Pennsaid, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus.
• Avoid use of NSAIDs, including Pennsaid, in pregnant women starting at 30 weeks of gestation (third trimester).
• There are no adequate and well-controlled studies of Pennsaid in pregnant women.
• Based on available data, diclofenac may be present in human milk.
• The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for
  Pennsaid and any potential adverse effects on the breastfed infant from the
  Pennsaid or from the underlying maternal condition.