Over-the-counter medication · Nonsteroidal Anti-Inflammatory Drug (NSAID)
diclofenac
Also sold as Voltaren, Cataflam. This medicine temporarily relieves arthritis pain.
Data updated 2026-05-15
- 82,165
- FDA reportsOften reported
- 11
- InteractionsSeveral interactions
- 2
- Recall records
What the data shows
diclofenac (Voltaren) is an over-the-counter Nonsteroidal Anti-Inflammatory Drug (NSAID), more reported than most tracked drugs (82,165 FDA reports), with 11 documented drug interactions.
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
diclofenac (Voltaren) is an over-the-counter Nonsteroidal Anti-Inflammatory Drug (NSAID). This medicine temporarily relieves arthritis pain.
Diclofenac is a gel that helps with arthritis pain in your hands, wrists, elbows, feet, ankles, or knees. It belongs to a class of drugs called NSAIDs.
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Generic Price
$1.44/unit
Generic Available
Yes (55 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
This medicine temporarily relieves arthritis pain.
Common side effects
Pain, Headache
Key warnings
No specific warnings noted. Always follow your prescriber's instructions.
The sections below are summarized in plain English from diclofenac's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Diclofenac is an NSAID. It reduces pain and swelling by blocking substances in the body that cause inflammation.
Side Effects (from patient reports)
Based on 82,165 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for diclofenac, by number of reports
- Pain
Pain
12,281 reports
- Fatigue
Fatigue
11,317 reports
- Rheumatoid Arthritis
Rheumatoid Arthritis
9,241 reports
- Rash
Rash
8,747 reports
- Arthralgia
Arthralgia
8,640 reports
- Abdominal Discomfort
Abdominal Discomfort
8,483 reports
- Alopecia
Alopecia
8,041 reports
- Systemic Lupus Erythematosus
Systemic Lupus Erythematosus
7,710 reports
- Joint Swelling
Joint Swelling
7,709 reports
- Pemphigus
Pemphigus
7,542 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for diclofenac each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where diclofenac sits
diclofenac has more FDA adverse-event reports than 82% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is diclofenac; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 82,165 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2001–2025.
Total Reports
82,165
Reports Mentioning Death
10,052
12.2% of reports — not proof of cause
Hospitalization Reports
30,047
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 2 | PAIN | 12,281 |
| 3 | FATIGUE | 11,317 |
| 4 | RHEUMATOID ARTHRITIS | 9,241 |
| 5 | RASH | 8,747 |
| 6 | ARTHRALGIA | 8,640 |
| 8 | ABDOMINAL DISCOMFORT | 8,483 |
| 9 | ALOPECIA | 8,041 |
| 10 | SYSTEMIC LUPUS ERYTHEMATOSUS | 7,710 |
| 11 | JOINT SWELLING | 7,709 |
| 12 | PEMPHIGUS | 7,542 |
| 13 | GLOSSODYNIA | 7,315 |
| 14 | SWELLING | 7,266 |
| 15 | ARTHROPATHY | 7,065 |
| 16 | HYPERSENSITIVITY | 6,877 |
| 17 | HAND DEFORMITY | 6,775 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Known Drug Interactions
7 DRUG INTERACTIONS See Table 1 for clinically significant drug interactions with diclofenac and misoprostol. Table 1: Clinically Significant Drug Interactions with Diclofenac and Misoprostol 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 an increased risk of serious bleeding compared to the use of either drug alone.
Mechanism: Diclofenac can increase the risk of serious bleeding in the stomach. Misoprostol is used with it to help protect the lining of the stomach and reduce this risk.
Table 3: Drugs that Can Increase the Risk of Bleeding Drug Class Specific Drugs Anticoagulants argatroban, dabigatran, bivalirudin, desirudin, heparin, lepirudin Antiplatelet Agents aspirin, cilostazol, clopidogrel, dipyridamole, prasugrel, ticlopidine Non-steroidal Anti-Inflammatory Agents celecoxib, diclofenac, diflunisal, fenoprofen, ibuprofen, indomethacin, ketoprofen, ketorolac, mefenamic acid, naproxen, oxaprozin, piroxicam, sulindac Serotonin Reuptake Inhibitors citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, fluvoxamine, milnacipran, paroxetine, sertraline,...
Mechanism: Diclofenac is an anti-inflammatory medicine that can increase the risk of bleeding when used with warfarin. This combination makes it harder for your blood to clot properly.
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.
Mechanism: Taking two different NSAID pain relievers at the same time increases the chance of serious side effects like stomach ulcers or kidney issues.
Conivaptan 33% 43% Diltiazem 20% NA Indomethacin 40% NA Mirabegron 29% 27% Nefazodone 27% 15% Nifedipine 45% NA Propantheline 24% 24% Quinine NA 33% Rabeprazole 29% 19% Saquinavir 27% 49% Spironolactone 25% NA Telmisartan 20 to 49% NA Tricagrelor 31% 28% Tolvaptan 30% 20% Trimethoprim 22 to 28% NA Digoxin concentrations increased, but magnitude is unclear Alprazolam, azithromycin, cyclosporine, diclofenac, diphenoxylate, epoprostenol, esomeprazole, ibuprofen, ketoconazole, lansoprazole, metformin, omeprazole Measure serum digoxin concentrations before initiating concomitant drugs.
Mechanism: Diclofenac may cause the amount of digoxin in your body to increase. It is not clear exactly how much the levels will change when these drugs are used together.
Although not specifically studied, fluconazole has the potential to increase the systemic exposure of other non-steroidal anti-inflammatory drugs (NSAIDs) that are metabolized by CYP2C9 (e.g., naproxen, lornoxicam, meloxicam, diclofenac).
Mechanism: Fluconazole blocks the liver protein that normally clears diclofenac, causing the pain medicine to build up in your system.
This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.
Common Questions
How long should I use this medicine?
Can I use it for a sports injury?
How often should I apply the gel?
How much gel should I use?
Where should I apply the gel?
Can I use a heating pad with this gel?
Can I cover the treated area with a bandage?
What should I do if it doesn't work after 7 days?
How should I store the dosing card?
Can I use this on more than two areas at once?
What are the common side effects of diclofenac?
Does diclofenac interact with other medications?
What drug class is diclofenac?
Has diclofenac been recalled?
Active Recalls
Failed Viscosity Specifications: Out of Specification (OOS) [slightly lower than the limit] result in viscosity for Diclofenac Sodium Gel, 3%.
SUN PHARMACEUTICAL INDUSTRIES INC
Failed PH Specifications
Cipla USA, Inc.
Related Medications in Nonsteroidal Anti-Inflammatory Drug (NSAID)
Other drugs grouped near diclofenac - same-class peers and common alternatives.
abatacept
Orencia
Orencia is a medicine that helps to reduce inflammation.
Compare with diclofenac →
acetaminophen
Tylenol
Acetaminophen (Tylenol) is a medicine that can relieve pain and reduce fever.
Compare with diclofenac →
acetaminophen/hydrocodone
Vicodin, Norco
This medicine contains acetaminophen and hydrocodone.
Compare with diclofenac →
acetaminophen/oxycodone
Percocet
Percocet is a strong pain medicine.
Compare with diclofenac →
adalimumab
Humira
Idacio is a medicine that blocks a protein called TNF.
Compare with diclofenac →
Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for diclofenac: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.
Similar FAERS report volume
Nearest drugs by total FAERS reports. This record: 82,165.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 12.23%.
- benzonatate Δ 0.01 pts · 15,513 reports · Antitussive (Non-Narcotic) 12.23%death share
- nortriptyline Δ 0.01 pts · 5,503 reports · Tricyclic Antidepressant (TCA) 12.25%death share
- carvedilol Δ 0.06 pts · 130,791 reports · Beta-Blocker (Alpha/Beta) 12.17%death share
- hydralazine Δ 0.08 pts · 28,498 reports · Vasodilator 12.32%death share
Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Pain Relievers Compared
NSAIDs vs acetaminophen, which OTC pain reliever to use
Narrow Therapeutic Index Drugs
FDA bioequivalence and label-record context for narrow therapeutic index medicines
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
What the FDA Data Shows for diclofenac
The FDA label for diclofenac (sold under brand names such as Voltaren, Cataflam) classifies it as an over-the-counter product in the Nonsteroidal Anti-Inflammatory Drug (NSAID) class. This medicine temporarily relieves arthritis pain. Official labeling lists 2 commonly reported side effects, including Pain, Headache.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 82,165 voluntary reports. The database also lists 11 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated moderate severity. NADAC pricing from CMS shows a generic unit cost of $1.44.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history (currently 2 recall records on file), and patent information are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. This registry does not provide medication decisions.
Last updated: July 29, 2024
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages