Diclofenac Sodium Side effects

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• Side effects of Diclofenac Sodium in details
• Diclofenac Sodium contraindications
• Diclofenac Sodium reviews

What are the possible side effects of Diclofenac Sodium?

Get emergency medical help if you have signs of an allergic reaction to Diclofenac Sodium: sneezing, runny or stuffy nose; wheezing or trouble breathing; hives; swelling of your face, lips, tongue, or throat.

Get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, feeling short of breath.

Stop using Diclofenac Sodium and call your doctor at once if you have:

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

• shortness of breath (even with mild exertion);

• swelling or rapid weight gain;

• signs of stomach bleeding - bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;

• liver problems - nausea, upper stomach pain, itching, tired feeling, flu-like symptoms, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• kidney problems - little or no urinating, painful or difficult urination, swelling in your feet or ankles, feeling tired or short of breath;

• high blood pressure - severe headache, pounding in your neck or ears, nosebleed, anxiety, confusion;

• low red blood cells (anemia) - pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating; or

• severe skin reaction - fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common Diclofenac Sodium side effects may include:

• indigestion, gas, stomach pain, nausea, vomiting;

• diarrhea, constipation;

• headache, dizziness, drowsiness;

• stuffy nose;

• itching, increased sweating;

• increased blood pressure; or

• swelling or pain in your arms or legs.

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.

Side effects of Diclofenac Sodium in details

Ocular

Transient burning and stinging were reported in approximately 15% of patients across studies with the use of Diclofenac Sodium ophthalmic solution, 0.1%. In cataract surgery studies, keratitis was reported in up to 28% of patients using Diclofenac Sodium ophthalmic solution, 0.1%, although in many of these cases keratitis was initially noted prior to the initiation of treatment. Elevated intraocular pressure following cataract surgery was reported in approximately 15% of patients undergoing cataract surgery. Lacrimation complaints were reported in approximately 30% of case studies undergoing incisional refractive surgery. The following adverse reactions were reported in approximately 10% or less of the patients: abnormal vision, acute elevated IOP, blurred vision, conjunctivitis, corneal deposits, corneal edema, corneal opacity, corneal lesions, discharge, eyelid swelling, eye pain, injection (redness), iritis, irritation, itching, lacrimation disorder, and ocular allergy.

Systemic

The following adverse reactions were reported in 3% or less of the patients: abdominal pain, asthenia, chills, dizziness, facial edema, fever, headache, insomnia, nausea, pain, rhinitis, viral infection and vomiting.

Clinical Practice

The following reactions have been identified during postmarketing use of topical Diclofenac Sodium ophthalmic solution, 0.1% in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. The reactions, which have been chosen for inclusion due to either their seriousness, frequency of reporting, possible causal connection to topical Diclofenac Sodium ophthalmic solution, 0.1%, or a combination of these factors, include corneal erosion, corneal infiltrates, corneal perforation, corneal thinning, corneal ulceration and epithelilal breakdown.

TO REPORT SUSPECTED ADVERSE REACTIONS, contact Altaire Pharmaceuticals, Inc., at 1-800-258-2471 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

What is the most important information I should know about Diclofenac Sodium?

• Diclofenac Sodium patch may cause dizziness or drowsiness. Theses effects may be worse if you take it with alcohol or certain medicines. Use Diclofenac Sodium patch with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Diclofenac Sodium patch is for use on the skin only. Do not get it in your eyes, nose, or mouth. If you get Diclofenac Sodium patch in your eye, wash the eye out with water or saline right away. Contact your doctor if irritation persists for more than 1 hour.
• Do NOT use more than 1 patch at a time or use Diclofenac Sodium patch for longer than prescribed without checking with your doctor.
• If irritation occurs at the application site, remove the patch and contact your doctor.
• Serious stomach ulcers or bleeding can occur with the use of Diclofenac Sodium patch. Taking it in high doses or for a long time, smoking, or drinking alcohol increases the risk of these side effects. Taking Diclofenac Sodium patch with food will NOT reduce the risk of these effects. Contact your doctor or emergency room at once if you develop severe stomach or back pain; black, tarry stools; vomit that looks like blood or coffee grounds; or unusual weight gain or swelling.
• Diclofenac Sodium patch is an NSAID. Before you start any new medicine, check the label to see if it has an NSAID (eg, ibuprofen) in it too. If it does or if you are not sure, check with your doctor or pharmacist.
• Do not take aspirin while you are using Diclofenac Sodium patch unless your doctor tells you to.
• Lab tests, including kidney and liver function, blood electrolyte levels, complete blood cell counts, and blood pressure, may be performed while you use Diclofenac Sodium patch. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Use Diclofenac Sodium patch with caution in the ELDERLY; they may be more sensitive to its effects, especially stomach bleeding and kidney problems.
• Diclofenac Sodium patch should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Diclofenac Sodium patch may cause harm to the fetus. Do not use it during the last 3 months of pregnancy. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Diclofenac Sodium patch while you are pregnant. It is not known if Diclofenac Sodium patch is found in breast milk. Do not breast-feed while using Diclofenac Sodium patch.

Diclofenac Sodium contraindications

Diclofenac Sodium in all formulations, Cataflam, Voltaren, and Voltaren-XR, is contraindicated in patients with known hypersensitivity to Diclofenac Sodium and Diclofenac Sodium-containing products. Diclofenac Sodium should not be given to patients who have experienced asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to Diclofenac Sodium have been reported in such patients.

References

1. DailyMed. "DICLOFENAC EPOLAMINE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
2. European Chemicals Agency - ECHA. "Diclofenac: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).
3. HSDB. "DICLOFENAC". https://toxnet.nlm.nih.gov/cgi-bin/s... (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology