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Zipsor Side Effects

Generic name: diclofenac

Medically reviewed by Drugs.com. Last updated on Oct 20, 2024.

Note: This document provides detailed information about Zipsor Side Effects associated with diclofenac. Some dosage forms listed on this page may not apply specifically to the brand name Zipsor.

Applies to diclofenac: oral capsule, oral capsule liquid filled, oral powder for solution, oral tablet, oral tablet enteric coated, oral tablet extended release.

Important warnings This medicine can cause some serious health issues

Oral route (capsule)

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 is contraindicated in the setting of CABG surgery.

NSAIDs also 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.

Oral route (tablet, delayed release; tablet, enteric coated; tablet, 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 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.

Oral route (tablet; capsule, liquid filled; powder for 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 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.

Serious side effects of Zipsor

Along with its needed effects, diclofenac (the active ingredient contained in Zipsor) 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:

More common

  • acid or sour stomach
  • belching
  • bleeding gums
  • blood in the urine or stools
  • bloody or black, tarry stools
  • burning while urinating
  • chest pain
  • chills
  • cough
  • clay-colored stools
  • cloudy urine
  • constipation
  • dark urine
  • decrease in urine output or decrease in urine-concentrating ability
  • diarrhea
  • dizziness
  • feeling of indigestion
  • fever
  • frequent urge to urinate
  • headache
  • heartburn
  • increased bleeding time
  • indigestion
  • itching skin or rash
  • light-colored stools
  • loss of appetite
  • nausea and vomiting
  • pain in the chest below the breastbone
  • painful or difficult urination
  • pale skin
  • pinpoint red spots on the skin
  • stomach bloating, burning, cramping, discomfort, upset, or pain
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • swelling or inflammation of the mouth
  • swollen glands
  • trouble breathing
  • unpleasant breath odor
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • upper right abdominal or stomach pain
  • vomiting of blood or material that looks like coffee grounds
  • weight loss
  • yellow eyes and skin

Less common

  • blistering, peeling, loosening of the skin
  • blurred vision
  • burning, crawling, itching, numbness, prickling, "pins and needles" , or tingling feelings
  • confusion
  • change in consciousness
  • discouragement
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • feeling of constant movement of self or surroundings
  • feeling sad or empty
  • irritability
  • joint or muscle pain
  • lack of appetite
  • lack or loss of strength
  • loss of consciousness
  • loss of interest or pleasure
  • nervousness
  • pain or discomfort in the arms, jaw, back, or neck
  • pale or blue lips, fingernails, or skin
  • red irritated eyes
  • red skin lesions, often with a purple center
  • redness, soreness, or itching skin
  • sensation of spinning
  • shakiness in the legs, arms, hands, or feet
  • sleepiness or unusual drowsiness
  • stiff neck or back
  • trembling or shaking of the hands or feet
  • trouble concentrating
  • trouble sleeping

Get emergency help immediately if any of the following symptoms of overdose occur while taking diclofenac:

Symptoms of overdose

Other side effects of Zipsor

Some side effects of diclofenac 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:

More common

  • bloated
  • continuing ringing or buzzing or other unexplained noise in the ears
  • difficulty in swallowing
  • excess air or gas in the stomach or intestines
  • hearing loss
  • lack or loss of strength
  • pain or burning in the throat
  • passing gas

Less common

  • burning, dry or itching eyes
  • discharge, excessive tearing
  • hair loss, thinning of the hair
  • increased sensitivity of the skin to sunlight
  • pain in the arms or legs
  • redness, pain, swelling of the eye, eyelid, or inner lining of eyelid
  • redness or other discoloration of the skin
  • severe sunburn

For healthcare professionals

Applies to diclofenac: compounding powder, intravenous solution, oral capsule, oral delayed release tablet, oral powder for reconstitution, oral tablet, oral tablet extended release, rectal suppository.

General

The most common adverse reactions among patients treated with this drug included; gastrointestinal events of abdominal pain, constipation, diarrhea, dyspepsia, flatulence, gross bleeding,/perforation, heartburn, nausea, gastric and duodenal ulcers, and vomiting; abnormal renal function, anemia, dizziness, edema, elevated liver enzymes, headaches, increased bleeding time, pruritus, rashes, and tinnitus.

Hepatic

Borderline elevations of 1 or more liver tests to less than 3 times the upper limit of the normal (3 x ULN) or greater elevations in transaminases occurred in about 15% of patients treated with this drug. Elevations to greater than 3 x ULN of AST occurred in about 2% (n=5700) of patients at some point during treatment. In an open-labeled trial among patients receiving NSAIDs, a higher incidence of transaminase elevations were observed in patients receiving diclofenac compared with other NSAIDs.[Ref]

Renal

Dermatologic

Hematologic

NSAIDs inhibit platelet aggregation and have been shown to prolong bleeding time in some patients. Unlike aspirin, the NSAID effect on platelet function is quantitatively less, of shorter duration, and reversible.[Ref]

Hypersensitivity

Metabolic

Nervous system

Cardiovascular

Clinical trials of several cyclooxygenase (COX)-2 selective and nonselective NSAIDs of up to 3 years duration have shown an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. All NSAIDs appear to have a similar risk. There is no consistent evidence that concurrent use of aspirin mitigates this increased risk and may be associated with an increased risk of serious gastrointestinal events.

Pharmacoepidemiological data reveal an increased risk of arteriothrombotic events associated with diclofenac use, particularly at a high dose and during long-term treatment. In a meta-analysis of long-term treatment with diclofenac 150 mg/day, compared with placebo use of this drug resulted in approximately 3 additional major vascular events per 1000 participants.[Ref]

Psychiatric

Other

Ocular

Gastrointestinal

NSAIDs including this drug, can cause serious gastrointestinal (GI) events which can occur at any time, with or without warning. For patients who develop a serious upper GI event, only about 20% were symptomatic. Upper GI ulcers, gross bleeding, or perforation occurred in approximately 1% of patients treated with NSAIDs for 3 to 6 months and 2% to 4% of patients treated for 1 year. Patients with a prior history of peptic ulcer disease and/or GI bleeding had a greater than 10-fold increased risk for developing a GI bleed than patients with neither of these risk factors.[Ref]

Genitourinary

Immunologic

Local

Respiratory

References

1. (2001) "Product Information. Voltaren (diclofenac)." Novartis Pharmaceuticals

2. Cerner Multum, Inc. "Australian Product Information."

Frequently asked questions

Further information

Zipsor side effects can vary depending on the individual. 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.