diclofenac sodium
Pharmaranks rates Diclofenac Sodium 3.5/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Diclofenac Sodium is a nonsteroidal anti-inflammatory drug used to treat Juvenile Arthritis, Rheumatoid Arthritis, Dysmenorrhea, Inflammation.
Nonsteroidal Anti-Inflammatory Drug · by Amneal
Generic of Voltaren Arthritis Pain
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Diclofenac Sodium
- Drug class
- Nonsteroidal Anti-Inflammatory Drug
- Form
- Solution, Drops, Topical, Tablet, delayed release, Tablet, extended release, Tablet, Kit
- Strength
- Diclofenac Sodium 3%
- Type
- Prescription (Rx)
- Brand or generic
- Generic
- May treat
- juvenile arthritis, rheumatoid arthritis, dysmenorrhea
- Manufacturer
- Amneal
- Half-life
- about 2 hours (terminal/elimination half-life; the label's table gives a mean of 2.3 hours in healthy adults, with wide variation between people — 48% coefficient of variation) (how long it stays in your system)
- What the pharmacy pays
- ~$0.36 per ml — not your price
- FDA application
- ANDA200936
- Availability
- Discontinued (per FDA)
- FDA boxed warning
- Yes — see the boxed warning
What is Diclofenac Sodium?
From the FDA label:Diclofenac Sodium Gel, 3%, contains the active ingredient, diclofenac sodium, in a clear, transparent, colorless to slightly yellow gel base. Diclofenac sodium is a white to slightly yellow crystalline powder. It is freely soluble in methanol, soluble in ethanol, sparingly soluble in water, slightly soluble in acetone, and partially insoluble in ether. The chemical name for diclofenac sodium is: Sodium [o-(2,6-dichloranilino) phenyl] acetate Diclofenac sodium has a molecular weight of 318.13. The CAS number is CAS-15307-79-6. The structural formula is represented below: Diclofenac Sodium Gel, 3% also contains benzyl alcohol, hydroxyethyl cellulose, methoxypolyethylene glycol 350, PEG-60 hydrogenated castor oil, and purified water. 1 g of Diclofenac Sodium Gel, 3% contains 30 mg of the active substance, diclofenac sodium. 352da3e2-figure-01
How to use
Diclofenac Sodium is sold in more than one form (Solution, Drops, Topical, Tablet, delayed release, Tablet, extended release, Tablet and Kit), and each is dosed differently. The instructions below come from the FDA label for application ANDA200936 — follow the label that came with the product you were actually prescribed.
Diclofenac Sodium Gel, 3% is applied to lesion areas twice daily. It is to be smoothed onto the affected skin gently. The amount needed depends upon the size of the lesion site. Assure that enough Diclofenac Sodium Gel, 3% is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site. The recommended duration of therapy is from 60 days to 90 days. Complete healing of the lesion(s) or optimal therapeutic effect may not be evident for up to 30 days following cessation of therapy. Lesions that do not respond to therapy should be carefully re-evaluated and management reconsidered.
Side effects
Of the 423 patients evaluable for safety in adequate and well-controlled trials, 211 were treated with diclofenac sodium gel, 3% drug product and 212 were treated with a vehicle gel. Eighty-seven percent (87%) of the diclofenac sodium gel, 3%-treated patients (183 patients) and 84% of the vehicle-treated patients (178 patients) experienced one or more adverse events (AEs) during the studies. The majority of these reactions were mild to moderate in severity and resolved upon discontinuation of therapy. Of the 211 patients treated with diclofenac sodium gel, 3%, 172 (82%) experienced AEs involving skin and the application site compared to 160 (75%) vehicle-treated patients. Application site reactions (ASRs) were the most frequent AEs in both diclofenac sodium gel, 3%-and vehicle-treated groups. Of note, four reactions, contact dermatitis, rash, dry skin and exfoliation (scaling) were significantly more prevalent in the diclofenac sodium gel, 3% group than in the vehicle-treated patients. Eighteen percent of diclofenac sodium gel, 3%-treated patients and 4% of vehicle-treated patients discontinued from the clinical trials due to adverse events (whether considered related to treatment or not). These discontinuations were mainly due to skin irritation or related cutaneous adverse reactions. Table 1 below presents the AEs reported at an incidence of >1% for patients treated with…
FDA Boxed Warning (the FDA’s most serious warning)
Boxed (black-box) warning — from the FDA label
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. - Diclofenac Sodium Gel, 3% is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.
Warnings
Important safety information
As with other NSAIDs, anaphylactoid reactions may occur in patients without prior exposure to diclofenac. Diclofenac sodium should be given with caution to patients with the aspirin triad. The triad typically occurs in asthmatic patients who experience rhinitis with or without nasal polyps, or who exhibit severe, potentially fatal bronchospasm after taking aspirin or other NSAIDs. Cardiovascular Thrombotic Events Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, including myocardial infarction (MI) and stroke, which can be fatal. Based on available data, it is unclear that the risk for CV thrombotic events is similar for all NSAIDs. The relative increase in serious CV thrombotic events over baseline conferred by NSAID use appears to be similar in those with and without known CV disease or risk factors for CV disease. However, patients with known CV disease or risk factors had a higher absolute incidence of excess serious CV thrombotic events, due to their increased baseline rate. Some observational studies found that this increased risk of serious CV thrombotic events began as early as the first weeks of treatment. The increase in CV thrombotic risk has been observed most consistently at higher doses. To minimize the potential risk for an adverse CV event in NSAID-treated patients, use the lowest effective dose for the shortest duration possible. Physicians and patients should remain alert for the development of such events, throughout the entire treatment course, even in the absence of previous CV symptoms. Patients should be informed about the symptoms of serious CV events and the steps to take if they occur. There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use. The concurrent use of aspirin and an NSAID, such as diclofenac, increases the risk of serious gastrointestinal (GI) events. Status Post Coronary Artery Bypass Graft (CABG) Surgery Two large, controlled clinical trials of a COX-2 selective NSAID for the treatment of pain in the first 10–14 days following CABG surgery found an increased incidence of myocardial infarction and stroke. NSAIDs are contraindicated in the setting of CABG. Post-MI Patients Observational studies conducted in the Danish National Registry have demonstrated that patients treated with NSAIDs in the post-MI period were at increased risk of reinfarction, CV-related death, and all-cause mortality beginning in the first week of treatment. In this same cohort, the incidence of death in the first year post MI was 20 per 100 person years in NSAID-treated patients compared to 12 per 100 person years in non-NSAID exposed patients. Although the absolute rate of death declined somewhat after the first year post-MI, the increased relative risk of death in NSAID users persisted over at least the next four years of follow-up. Avoid the use of diclofenac sodium gel, 3% in patients with a recent MI unless the benefits are expected to outweigh the risk of recurrent CV thrombotic events. If diclofenac sodium gel, 3% is used in patients with a recent MI, monitor patients for signs of cardiac ischemia. Heart Failure and Edema The Coxib and traditional NSAID Trialists’ Collaboration meta-analysis of randomized controlled trials demonstrated an approximately two-fold increase in hospitalizations for heart failure in COX-2 selective-treated patients and nonselective NSAID-treated patients compared to placebo-treated patients. In a Danish National Registry study of patients with heart failure, NSAID use increased the risk of MI, hospitalization for heart failure, and death. Additionally, fluid retention and edema have been observed in some patients treated with NSAIDs. Use of diclofenac may blunt the CV effects of several therapeutic agents used to treat these medical conditions [e.g., diuretics, ACE inhibitors, or angiotensin receptor blockers (ARBs)]. Avoid the use of diclofenac sodium gel, 3% in patients with severe heart failure unless the benefits are expected to outweigh the risk of worsening heart failure. If diclofenac sodium gel, 3% is used in patients with severe heart failure, monitor patients for signs of worsening heart failure.
Who should not take Diclofenac Sodium
Diclofenac Sodium Gel, 3% is contraindicated in patients with a known hypersensitivity to diclofenac, benzyl alcohol and/or polyethylene glycol monomethyl ether 350. Diclofenac Sodium Gel, 3% is contraindicated in the following patients: - In the setting of coronary artery bypass graft (CABG) surgery.
Overdose — what happens if you take too much
Due to the low systemic absorption of topically-applied diclofenac sodium gel, 3%, overdosage is unlikely. There have been no reports of ingestion of diclofenac sodium gel, 3%. In the event of oral ingestion, resulting in significant systemic side effects, it is recommended that the stomach be emptied by vomiting or lavage. Forced diuresis may theoretically be beneficial because the drug is excreted in the urine. The effect of dialysis or hemoperfusion in the elimination of diclofenac (99% protein-bound) remains unproven. In addition to supportive measures, the use of oral activated charcoal may help to reduce the absorption of diclofenac. Supportive and symptomatic treatment should be given for complications such as renal failure, convulsions, gastrointestinal irritation and respiratory depression.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
How long does Diclofenac Sodium stay in your body?
The elimination half-life of diclofenac sodium is about 2 hours (terminal/elimination half-life; the label's table gives a mean of 2.3 hours in healthy adults, with wide variation between people — 48% coefficient of variation) — the time it takes the body to clear about half of it. As a rule of thumb, a medicine is mostly gone after roughly 4 to 5 half-lives, though this varies from person to person with age and kidney or liver function. This is the terminal (elimination) half-life of unchanged diclofenac, as the label labels it — "Terminal Half-life (hr) 2.3" in the PK table, and in the text "the terminal half-life of unchanged diclofenac is approximately 2 hours." Diclofenac is not a prodrug, and it has no active metabolite that outlasts it: the label names five metabolites and says the major one, 4'-hydroxy-diclofenac, has "very weak pharmacologic activity," so the parent's ~2-hour half-life is what governs. (The related diclofenac/misoprostol label notes one additional urinary metabolite with an 80-hour half-life, but it accounts for only ~1.4% of the dose.) Populations the label names: kidney impairment — no dose adjustment for mild-to-moderate impairment; in subjects with inulin clearance 60-90, 30-60 and <30 mL/min, AUC and elimination rate were comparable to healthy subjects. Liver impairment — hepatic metabolism accounts for almost 100% of diclofenac elimination, so patients with liver disease may need reduced doses; the label does not give a revised half-life number. This label reports no pharmacokinetic study in older adults or in children; the diclofenac/misoprostol label found no PK differences in subjects aged 66-81 versus younger adults. Half-life describes how the drug leaves plasma. It is not a detection window (metabolites are detectable far longer) and not dosing guidance.
This is general information, not medical advice. It doesn’t tell you when a drug test would read negative (tests detect substances for different, often longer, windows) or when it’s safe to take another dose — ask your pharmacist or prescriber. Source: DailyMed — DICLOFENAC SODIUM tablet, delayed release (FDA label, Clinical Pharmacology / Pharmacokinetics).
Drug class
How this class works, per Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) - StatPearls - NCBI Bookshelf.
May treat (source: NIH RxClass)
See how Diclofenac Sodium ranks — best-rated nonsteroidal anti-inflammatory drug for:
Dosage forms
Solution, Drops, Topical, Tablet, delayed release, Tablet, extended release, Tablet and Kit
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
A same-class option may cost less. See alternatives →
Frequently asked questions
- What does Diclofenac Sodium treat?
- Diclofenac Sodium (Diclofenac Sodium) may be used to treat juvenile arthritis, rheumatoid arthritis, dysmenorrhea, inflammation, keratosis, osteoarthritis, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How does Diclofenac Sodium work?
- Diclofenac Sodium is a nonsteroidal anti-inflammatory drug. NSAIDs block cyclooxygenase (COX) enzymes that your body uses to make prostaglandins, the chemicals behind pain, swelling, and fever. Lowering prostaglandins eases pain and inflammation and brings down a high temperature.
- How is Diclofenac Sodium rated?
- pharmaranks gives Diclofenac Sodium a composite score of 3.5 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- How much does Diclofenac Sodium cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $0.36 per ml, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins. Pharmacies pay less for a same-class option, Advil — about $0.04 on the same basis.
- Is there a coupon or discount for Diclofenac Sodium?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Diclofenac Sodium. To pay less, Diclofenac Sodium is already a generic — usually the lowest-cost version — so the main levers are comparing cash prices between pharmacies and using a pharmacy discount-card service. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Diclofenac Sodium?
- Diclofenac Sodium is marketed by Amneal. You can see Amneal's full profile, rating, and other products on pharmaranks.
- Is Diclofenac Sodium a brand-name or generic drug?
- Diclofenac Sodium is a generic medication; its active ingredient is Diclofenac Sodium. Generics contain the same active ingredient as the brand-name original and are usually lower cost.
- Is Diclofenac Sodium available over the counter?
- No. Diclofenac Sodium is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Diclofenac Sodium come in?
- Diclofenac Sodium is currently marketed as solution, drops, topical, tablet, delayed release, tablet, extended release, tablet and kit, per the FDA's National Drug Code Directory.
- What class of drug is Diclofenac Sodium?
- Diclofenac Sodium is classified as nonsteroidal anti-inflammatory drug, per the FDA's Established Pharmacologic Class.
- Is Diclofenac Sodium FDA-registered?
- Diclofenac Sodium is on record with the U.S. FDA under application number ANDA200936. You can verify this on its official FDA label.
- Has Diclofenac Sodium been recalled by the FDA?
- Diclofenac Sodium has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Diclofenac Sodium safe?
- There's no single safe-or-not verdict. pharmaranks gives Diclofenac Sodium a recall-safety score of 70/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Diclofenac Sodium?
- Diclofenac Sodium's side effects are taken directly from its FDA label. From the label: Of the 423 patients evaluable for safety in adequate and well-controlled trials, 211 were treated with diclofenac sodium gel, 3% drug product and 212 were treated with a vehicle gel. Eighty-seven percent (87%) of the diclofenac sodium gel,… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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