Voltaren Arthritis Paindiclofenac
According to the FDA label: Uses for the temporary relief of arthritis pain ONLY in the following areas: hand, wrist, elbow (upper body areas) foot, ankle, knee (lower body areas) this product may take up to 7 days to work for arthritis pain; it is not for immediate relief. If no pain relief in 7 days, stop use.
99,124 adverse event reports submitted to the FDA (2001–2026)
Top Reported Adverse Events
The most frequently reported events in association with Voltaren Arthritis Pain in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
Show these terms with plain-language definitions
Tap any term below for a plain-language definition.
Drug Ineffective 23,370 reports
A report that the medication did not work as expected for the person taking it. This is a reporting category, not a sign the drug is defective. It simply means someone felt it was not helping their condition.
Full definition in the glossary →Product Use in Unapproved Indication 11,698 reports
Using a medication for a condition it is not officially approved to treat. Like off label use, this is a reporting category and does not by itself mean harm occurred.
Full definition in the glossary →Off Label Use 9,816 reports
Using a medication for a condition or in a way that the FDA has not officially approved. This is common and often legal, and a report of it does not mean something went wrong. Doctors sometimes prescribe drugs off label based on their judgment.
Full definition in the glossary →Pain 9,610 reports
A general report of physical discomfort, used when no more specific location is given.
Full definition in the glossary →Fatigue 8,626 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Product Use Issue 7,780 reports
A general report that there was some problem in how the medication was used.
Full definition in the glossary →Rash 7,449 reports
An area of irritated, red, or bumpy skin.
Full definition in the glossary → See all drugs reporting this event →- Product Administered At Inappropriate Site 6,949 reports
Rheumatoid Arthritis 6,937 reports
An autoimmune condition where the immune system attacks the joints, causing pain and swelling. It often appears in reports because it is a condition being treated, not always a reaction.
Full definition in the glossary →- Drug Effective For Unapproved Indication 6,759 reports
Abdominal Discomfort 6,585 reports
A general unease or mild pain in the belly area.
Full definition in the glossary →Arthralgia 6,450 reports
Alopecia 6,075 reports
Systemic Lupus Erythematosus 5,953 reports
An autoimmune condition, often called lupus, where the immune system attacks the body's own tissues, affecting joints, skin, and organs. It often appears in reports because it is a condition being treated, not always a reaction.
Full definition in the glossary →Joint Swelling 5,898 reports
Swelling in or around a joint.
Full definition in the glossary →
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Female | 50,204 |
| Male | 22,074 |
| Unknown | 86 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 818 |
| 18-34 | 2,528 |
| 35-49 | 10,394 |
| 50-64 | 12,257 |
| 65-74 | 9,520 |
| 75+ | 10,617 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Voltaren Arthritis Pain. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Non-Serious | 49,802 |
| Other Serious | 35,764 |
| Hospitalization | 23,225 |
| Death | 9,058 |
| Life-Threatening | 8,150 |
| Disability | 8,015 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Voltaren Arthritis Pain. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 2001 | 2 |
| 2002 | 2 |
| 2003 | 3 |
| 2004 | 1,074 |
| 2005 | 1,135 |
| 2006 | 1,112 |
| 2007 | 1,324 |
| 2008 | 1,504 |
| 2009 | 1,550 |
| 2010 | 1,875 |
| 2011 | 2,385 |
| 2012 | 2,241 |
| 2013 | 1,114 |
| 2014 | 1,643 |
| 2015 | 3,497 |
| 2016 | 4,867 |
| 2017 | 3,849 |
| 2018 | 4,042 |
| 2019 | 3,933 |
| 2020 | 10,736 |
| 2021 | 15,420 |
| 2022 | 8,868 |
| 2023 | 9,931 |
| 2024 | 9,043 |
| 2025 | 6,932 |
| 2026 (partial) | 1,042 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Voltaren Arthritis Pain
In FDA adverse event reports that mention Voltaren Arthritis Pain, these medications appeared most often in the same report.
- Diclofenac Topical % (34,393 reports)
- Diclofenac Topical (34,388 reports)
- Methotrexate (14,347 reports)
- Acetaminophen (13,400 reports)
- Prednisone (13,026 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026