FDA-filed SPL labeling · retrieved through openFDA

Salsalate

Salsalate is a salicylate anti-inflammatory medicine used to relieve the signs and symptoms of rheumatoid arthritis, osteoarthritis, and related rheumatic disorders.

Brand name Disalcid
Rx Form 1 Route Oral
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 5 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

At a glance
Linked label effectiveFeb 8, 2024
Clinical labels in scope 5
AvailabilityRx
Earliest approval/marketing year 2010
FDA-listed product records 34
Boxed warningYes
How we combine label and product data →
No current FDA shortage listed · checked Sep 23, 2026
Salsalate at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Salsalate is a salicylate anti-inflammatory tablet used to manage rheumatoid arthritis, osteoarthritis, and related rheumatic conditions. It carries important risks — including heart attack, stroke, and serious stomach bleeding — so it should be taken at the lowest effective dose for the shortest time necessary. Talk openly with your prescriber about your health history, any other medicines you take, and any new symptoms that develop while using it.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert

Salsalate can increase the risk of serious — and sometimes fatal — heart attack, stroke, and stomach bleeding. Like other NSAIDs, this risk can grow the longer you take it. People who already have heart disease or risk factors for it may be at greater risk. Salsalate must not be used for pain relief around the time of coronary artery bypass graft (CABG) heart surgery. Additionally, NSAIDs including salsalate can cause serious stomach problems — including ulcers, bleeding, and perforation of the stomach or intestines — that can happen at any time, even without warning symptoms. Older adults are especially vulnerable to these stomach complications. Seek medical help right away if you have chest pain, sudden weakness or speech problems, or notice blood in your stool.

Read the full warning on DailyMed →

📖 Salsalate: Patient Information Guide

A plain-language walkthrough of Salsalate — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for

Salsalate is a salicylate anti-inflammatory used to relieve pain, swelling, and stiffness caused by inflammatory joint conditions.

  • Rheumatoid arthritis
  • Osteoarthritis
  • Related rheumatic disorders
⚙️How it works

Salsalate belongs to the salicylate family — the same class as aspirin. Once it reaches the intestine and is absorbed, the body converts it to salicylic acid. This compound works by inhibiting the production of prostaglandins, the chemical signals your body uses to trigger pain, swelling, and inflammation in the joints. Less prostaglandin means less inflammation and less pain.

Because salsalate itself is not absorbed in the acidic stomach environment, it passes through to the small intestine before being taken into the bloodstream. The body also responds over time by ramping up liver enzymes that break down salicylate, which means your dose may need adjustment to maintain a steady therapeutic level.

💊How it's taken

Salsalate tablets are taken by mouth in divided doses spread through the day — typically two or three times daily. Your prescriber will set the schedule that fits your needs, and may adjust it based on how you respond. Older adults may need a lower dose to avoid side effects like ringing in the ears.

  • Relief builds gradually — full benefit may not appear until after 3 to 4 days of consistent use
  • Use the lowest effective dose for the shortest time needed
  • Do not adjust your dose on your own; follow your prescriber and pharmacist's guidance
  • Salsalate dosing has not been established for children
🤒Side effects — in detail

The most commonly reported side effects with salsalate involve its salicylate nature — many are dose-related and reversible.

  • Tinnitus (ringing in the ears)
  • Nausea
  • Hearing impairment
  • Skin rash
  • Vertigo (dizziness)
  • Abdominal pain
  • Diarrhea
  • Abnormal liver function

More serious reactions — including stomach bleeding, severe allergic reactions, dangerous skin conditions, and kidney problems — have been reported and require immediate medical attention if they occur. Ringing in the ears can be a sign that your salicylate level is too high; tell your doctor right away if this happens.

⚠️Warnings & precautions

The most important risks with salsalate are cardiovascular events and gastrointestinal bleeding. Like all NSAIDs, salsalate raises the risk of heart attack and stroke — risks that increase with longer use and are higher in people who already have heart disease. It also increases the risk of serious stomach and intestinal bleeding, ulcers, and perforation, which can happen without any warning signs. Older adults and people with a prior history of ulcers or stomach bleeding face the greatest GI risk.

  • Heart and blood vessel risk: increased risk of heart attack and stroke; do not use for pain after CABG heart surgery
  • Stomach bleeding and ulcers: can occur at any time, even without symptoms — risk rises with alcohol use, steroids, blood thinners, or older age
  • Kidney effects: can reduce kidney function, especially in older adults or those with heart failure, liver disease, or existing kidney problems
  • Pregnancy risks: avoid after about 30 weeks of pregnancy; use with caution and medical guidance between 20–30 weeks
  • Reye's Syndrome: do not use in people (especially children) with chicken pox, flu, or flu-like illness
  • Serious skin reactions: rare but potentially fatal reactions including Stevens-Johnson Syndrome and DRESS have been reported — stop the medicine and seek care at the first sign of rash or skin changes
  • Severe allergic reactions: anaphylaxis has occurred — do not take if you have the aspirin triad (asthma, nasal polyps, aspirin sensitivity)
🔀What it interacts with

Salsalate can interact with several common medications and substances — always tell your prescriber and pharmacist everything you take.

  • Aspirin and other salicylates: can stack up to toxic salicylate blood levels — generally avoid combining
  • Warfarin and other anticoagulants (blood thinners): greatly increases risk of serious bleeding
  • ACE inhibitors (blood pressure medicines): salsalate may reduce their effectiveness
  • Furosemide and thiazide diuretics (water pills): salsalate may reduce how well they remove fluid and salt
  • Lithium: salsalate can raise lithium blood levels, increasing the risk of lithium toxicity
  • Methotrexate: salsalate may increase methotrexate toxicity — use together with caution
  • Sulfonylurea diabetes medicines: salsalate may strengthen their blood-sugar-lowering effect, risking low blood sugar
  • Gout medicines (uricosurics like probenecid): salicylates can block their uric-acid-lowering action

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it
  • Do not take salsalate if you are allergic to it, or if you have ever had asthma, hives, or a serious reaction to aspirin or any other NSAID
  • Do not use salsalate for pain relief immediately before or after CABG (coronary artery bypass graft) heart surgery
  • Tell your doctor if you have heart disease, high blood pressure, or a history of heart attack or stroke
  • Tell your doctor if you have heart failure or tend to retain fluid
  • Tell your doctor if you have kidney or liver disease — salsalate is not recommended if you have advanced kidney disease
  • Tell your doctor if you have a history of stomach ulcers or gastrointestinal bleeding
  • Tell your doctor if you smoke or drink alcohol regularly — both increase the risk of stomach bleeding
  • Avoid salsalate from about 30 weeks of pregnancy onward; discuss the risks carefully with your doctor if you need it between 20–30 weeks
  • Do not give salsalate to children — dosing has not been established, and there is a risk of Reye's Syndrome
  • Do not use in anyone with chicken pox, flu, or flu-like symptoms due to the risk of Reye's Syndrome
  • Older adults are at higher risk for stomach bleeding and kidney problems — extra care and possibly lower doses are needed
🚑If you take too much

Taking too much salsalate can cause salicylism — symptoms include ringing in the ears, dizziness, headache, confusion, drowsiness, sweating, rapid breathing, vomiting, and diarrhea. Severe overdose can disturb the body's fluid and electrolyte balance, cause a dangerous drop in blood pH, and lead to overheating and dehydration. If you suspect an overdose, call Poison Control or go to the nearest emergency room immediately — do not wait for symptoms to worsen.

📡Pharmacodynamics — effects in the body

Salsalate reduces the body's production of prostaglandins — the chemical messengers responsible for triggering pain, inflammation, and swelling in the joints. By lowering prostaglandin levels, it reduces joint inflammation and relieves associated pain and stiffness. Because prostaglandins also affect kidney blood flow, the stomach lining, and blood vessel function, blocking them can have effects throughout the body beyond just the joints.

🔬Pharmacokinetics — how your body processes it

Salsalate is not absorbed in the acidic environment of the stomach — it passes into the small intestine before being taken into the bloodstream. Once absorbed, it is broken down into salicylic acid, which is the active form that reduces inflammation. Steady therapeutic blood levels typically take about 3 to 4 days to build up with regular dosing. Over time, the liver may increase its enzyme activity to break down salicylate faster, meaning the dose may need adjustment to maintain effectiveness.

📦How to store it

Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) .

📄 Written from Salsalate’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

37

Supplements & herbs that interact with Salsalate

37 supplements and herbal products have documented interactions with Salsalate in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 5
  • Moderate · 20
  • Minor · 12
Every supplement checked against Salsalate — ranked by severity The full interaction hub: 5 major · 20 moderate · 12 minor · every one linked to its full report. Check Salsalate against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

1

Nutrient depletion considerations

Salsalate has been associated with lower levels of 1 nutrient in the clinical literature. This does not mean a deficiency will occur — it means these may be worth discussing with your pharmacist or healthcare provider, especially with long-term use.

See the full Salsalate nutrient depletion report

Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.

🩺 Pharmacist Counseling Corner

Quick, plain-English answers to the questions patients ask most about Salsalate — the kind of thing our pharmacy team would talk through with you at the counter.

What exactly is salsalate and how is it different from aspirin?
Salsalate is a close cousin of aspirin — both belong to the salicylate family and work by reducing inflammation in your body. The main practical difference is that salsalate isn't absorbed in your stomach the way aspirin is; it moves to the small intestine first before entering your bloodstream. It's prescribed specifically to manage the pain and stiffness of conditions like rheumatoid arthritis and osteoarthritis, rather than for everyday headaches or fever.
How long does it take for salsalate to start working?
Don't be discouraged if you don't feel better right away — salsalate works gradually. It can take 3 to 4 days of regular use before salicylate levels in your blood reach a steady, therapeutic level and you notice the full benefit. Stick with the schedule your prescriber set for you, and let them know if you're not getting relief after a week or so.
What side effects should I watch out for?
The most common ones are ringing in the ears (tinnitus), nausea, some hearing changes, dizziness, and rash. Ringing in the ears is actually a useful signal — if you notice it, tell your doctor, because it can mean your salicylate level is getting too high. More serious problems — like black or tarry stools, vomiting blood, chest pain, sudden weakness, or severe stomach pain — need immediate medical attention. Don't wait and see with those.
Are there medicines I should avoid while taking salsalate?
Yes, quite a few. Taking aspirin or other salicylates along with salsalate can push salicylate levels to toxic amounts, so that combination is generally avoided. Blood thinners like warfarin increase bleeding risk significantly when combined with salsalate. Salsalate can also interfere with certain blood pressure medicines, water pills, lithium, methotrexate, and some diabetes medicines. Always give your pharmacist and doctor a full list of everything you take — including vitamins and over-the-counter products.
Can I take salsalate if I'm pregnant?
This is a really important question. Salsalate should be avoided from about 30 weeks of pregnancy onward because it can affect a critical blood vessel in your baby's heart and may harm the baby's kidneys. Between about 20 and 30 weeks, it should only be used under close medical supervision, at the lowest possible dose, for the shortest time. If you're pregnant or trying to become pregnant, talk to your doctor before using salsalate.
I heard there's a heart and stomach warning with this medicine — how worried should I be?
It's worth taking seriously, but not panicking about. Like all NSAIDs, salsalate does carry a real risk of heart attack, stroke, and serious stomach bleeding — especially with longer use or if you already have heart disease, high blood pressure, or a history of ulcers. The key is to use the lowest dose that helps, for the shortest time needed, and to stay alert for warning signs like chest pain, sudden weakness or speech changes, or blood in your stool. Your prescriber weighed those risks against the benefits when they prescribed it for you — just keep them in the loop about how you're doing.
Is Salsalate available over the counter?
Salsalate is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
When was Salsalate first available?
Salsalate has been available in the United States since at least 2010, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Salsalate?
Salsalate is supplied by 11 manufacturers listed in the FDA NDC Directory, including Bryant Ranch Prepack, Westminster Pharmaceuticals, LLC, Amneal Pharmaceuticals LLC.

💬 Answers drafted from Salsalate’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

💊 How Salsalate comes

Salsalate is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Tablet

By mouth
How this form is used
What it may be used for
  • Salsalate tablets are used to relieve the signs and symptoms of rheumatoid arthritis
  • Salsalate tablets are used to relieve the signs and symptoms of osteoarthritis
  • Salsalate tablets are used for related rheumatic disorders
Important instructions
  • Salsalate tablets are taken by mouth in divided doses throughout the day — follow your prescriber's schedule exactly
  • Salsalate tablets should be used at the lowest effective dose for the shortest duration your condition requires
  • Full relief from Salsalate tablets may take 3 to 4 days — do not increase your dose on your own if you don't feel immediate results
  • Elderly patients taking Salsalate tablets may need a lower dose to avoid side effects such as ringing in the ears — your prescriber will adjust as needed
Available strengths 2 strengths
29 FDA-listed product records

📊 Salsalate across the U.S. market

How Salsalate appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

1
Dose forms
11
Manufacturers
1
Brand names
34
FDA-listed product records
2010
First marketed

Also listed with the FDA, not a patient dose form: Powder (5) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Bryant Ranch Prepack29%
Westminster Pharmaceuticals, LLC21%
Amneal Pharmaceuticals LLC18%
Acella Pharmaceuticals, LLC6%
ECI Pharmaceuticals LLC6%
Proficient Rx LP6%
Other makers15%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

📈 How widely Salsalate is used

A general measure of how commonly Salsalate is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Salsalate is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

856
Medicaid prescriptions filled (Q1–Q4 2025)
$26,158 gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Salsalate prescribed? Of the 1,596 medications we measure, Salsalate ranks #1,304 by Medicaid prescriptions — more than 18% of them.

Where Salsalate ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Salsalate product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 750 mg oral tablet is the most-dispensed Salsalate product — about 63% of these Medicaid prescriptions.

salsalate 750 MG Oral Tablet Most dispensed

537 Medicaid prescriptions (Q1–Q4 2025) 63% of Salsalate prescriptions shown $16,161 gross reimbursement (before rebates) ≈ $30 per prescription (gross)

Summed across the 2 of 62 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 583170

salsalate 500 MG Oral Tablet

319 Medicaid prescriptions (Q1–Q4 2025) 37% of Salsalate prescriptions shown $9,997 gross reimbursement (before rebates) ≈ $31 per prescription (gross)

Summed across the 2 of 39 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 312899

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Salsalate, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 4 of 101 listed Salsalate NDCs with Medicaid activity.

🔍 Compare Salsalate products

A representative set of FDA-listed product records for Salsalate — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 34 of 34 products — FDA National Drug Code Directory. See every product, package size and price: browse all 34 Salsalate NDCs →

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Salsalate RxCUI 36108 2 dose forms · 3 strengths
  1. Dose form (SCDF) Oral Capsule RxCUI 373822 No current FDA listing
    Clinical drug / strength (SCD) 500 MG RxCUI 105798
  2. Dose form (SCDF) Oral Tablet RxCUI 583169 In current FDA listings
    Clinical drug / strength (SCD) 500 MG RxCUI 312899 750 MG RxCUI 583170

Look up RxCUI 36108 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

🏷️ Sold under these brand names

Disalcid

🏭 Manufacturers & labelers

Bryant Ranch Prepack 10 Westminster Pharmaceuticals, LLC 7 Amneal Pharmaceuticals LLC 6 Acella Pharmaceuticals, LLC 2 ECI Pharmaceuticals LLC 2 Proficient Rx LP 2 Aurore Pharmaceuticals Private Limited 1 Kreative Actives Private Limited 1 Kreative Organics Private Limited 1 Raks Pharma Pvt. Limited 1 Wanbury Limited 1

RxNorm drug class

Salsalate belongs to the Salicylic acid and derivatives class.

Drug family (ATC) Salicylic acid and derivatives

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

🔬 Where this comes from

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Feb 8, 2024
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Salsalate.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Salsalate after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
5
NDC products indexed
34
Distinct labelers/manufacturers represented
11
Linked representative label
Westminster Pharmaceuticals, LLC
Linked label effective
Feb 8, 2024
Composite sections available
19
Linked SPL Set ID
24815546-658b-4b01-ac11-de7fbd0ebd16
Linked SPL Document ID
56747829-5049-405d-8d69-83c34d70002b
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 5 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Westminster Pharmaceuticals, LLC is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.