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Aspirin (Low-Dose)

Low-dose aspirin (acetylsalicylic acid, often called “baby aspirin”) is an antiplatelet drug used to prevent heart attacks and strokes. Taken once a day at low doses (81–100 mg in most of the trials below), it blocks the platelet enzyme that helps blood clots form. In the US it is sold over the counter, and FDA’s professional labeling lists vascular uses such as preventing a second heart attack or stroke.

The single most important fact is the split in the evidence. In people who already have cardiovascular disease (secondary prevention), aspirin clearly lowers the risk of heart attack and stroke. In people who do not (primary prevention), three large trials published in 2018 found small or no benefit and a consistent increase in serious bleeding. In 2022 the US Preventive Services Task Force (USPSTF) recommended against starting aspirin for primary prevention at age 60 or older.

Some testosterone and anabolic steroid users take aspirin as a “blood thinner” (Kutscher et al., Harm Reduct J 2024). This page explains what the evidence does and does not show for that group. It summarizes what the FDA labeling, clinical trials and guideline bodies report. It is for education only and is not medical advice.

Property Detail
Drug class Antiplatelet agent; salicylate nonsteroidal anti-inflammatory drug (NSAID)
Chemistry Acetylsalicylic acid (2-acetyloxybenzoic acid), C₉H₈O₄, 180.16 g/mol
US status Over the counter (for example 81 mg delayed-release tablets); professional labeling for vascular uses in 21 CFR 343.80; prescription extended-release capsule (Durlaza, 162.5 mg) approved 2015
Route Oral
Labeled vascular doses 50–325 mg once daily after ischemic stroke or TIA; 75–325 mg once daily after heart attack or with angina
Half-life Aspirin itself ≈20–60 min; its metabolite salicylic acid ≈6 h (labeling)
Key mechanism Irreversibly acetylates COX-1 in platelets; the effect lasts the platelet’s lifespan of about 7–10 days
USPSTF 2022 (primary prevention) Individual decision at ages 40–59 with 10-year CVD risk of 10% or more (grade C); do not start at 60 or older (grade D)
WADA status Not on the 2026 Prohibited List

What it is

Aspirin is the acetyl ester of salicylic acid, formula C₉H₈O₄, molecular weight 180.16 g/mol (PubChem). FDA’s professional labeling describes it as an odorless white crystalline powder that breaks down into salicylic and acetic acid when exposed to moisture, which gives old tablets a vinegar smell (21 CFR 343.80).

How it prevents clots

The label explains the mechanism in three steps (Durlaza label):

  • The acetyl group of aspirin binds a serine residue in cyclooxygenase-1 (COX-1) and permanently inactivates the enzyme.
  • Without COX-1, platelets cannot turn arachidonic acid into thromboxane A₂, a strong signal for platelets to clump together.
  • Because the block is irreversible, each affected platelet stays inhibited for its lifespan of about 7–10 days.

The acetyl group is what separates aspirin from other salicylates. The professional labeling notes that aspirin inhibits platelet aggregation more potently than other salicylic acid derivatives for this reason (21 CFR 343.80).

The labeled mechanism is about platelet function. Accordingly, the clotting-related lab change the labeling lists is a prolonged bleeding time.

Pharmacokinetics

Aspirin itself is very short-lived. The antiplatelet effect outlasts the drug by days because the enzyme block is permanent.

Parameter Value Source
Absorption (immediate release) Well and completely absorbed; salicylic acid peaks 1–2 h after dosing 21 CFR 343.80
Enteric-coated tablets Absorbed erratically 21 CFR 343.80
Aspirin in plasma Rapidly hydrolyzed to salicylic acid; essentially undetectable 1–2 h after an immediate-release dose 21 CFR 343.80
Aspirin half-life 20–60 min Durlaza label
Salicylic acid half-life About 6 h; over 20 h after toxic doses of 10–20 g, because metabolism saturates 21 CFR 343.80
Metabolism Liver conjugation to salicyluric acid and glucuronides 21 CFR 343.80
Protein binding About 90% bound to albumin at low concentrations 21 CFR 343.80

The extended-release Durlaza capsule reaches peak aspirin levels in about 2 h instead of 1 h. Its peak is about 35% and its total exposure about 70% of that from 81 mg immediate-release aspirin (Durlaza label).

Approved medical use

In the US, aspirin’s cardiovascular uses are set out in FDA’s professional labeling for over-the-counter aspirin. This text is written for clinicians, not for the consumer package (21 CFR 343.80). Every vascular indication applies to people who already have vascular disease or an acute event:

Indication Labeled dose
Ischemic stroke or transient ischemic attack (TIA) 50–325 mg once daily, indefinitely
Suspected acute heart attack (MI) 160–162.5 mg at once, then daily for 30 days
Prevention of recurrent MI 75–325 mg once daily, indefinitely
Unstable angina 75–325 mg once daily, indefinitely
Chronic stable angina 75–325 mg once daily, indefinitely
After coronary bypass surgery (CABG) 325 mg daily from 6 h after surgery, for 1 year

The labeling also covers revascularization procedures and high-dose use in arthritis. None of the labeled indications is primary prevention in healthy people.

The prescription extended-release capsule Durlaza (162.5 mg once daily) is indicated to lower the risk of death and MI in chronic coronary artery disease and of death and recurrent stroke after ischemic stroke or TIA. Its label states it should not be used where a fast onset is needed, such as an acute heart attack (Durlaza label).

The consumer 81 mg package carries only an analgesic “Drug Facts” label, with a stomach-bleeding warning, and lists use as recommended by a doctor (DailyMed, 81 mg OTC label).

What the research shows

Secondary prevention: clear net benefit

The Antithrombotic Trialists’ (ATT) Collaboration pooled individual patient data from 16 secondary prevention trials, covering about 17,000 people with prior vascular disease (ATT Collaboration, Lancet 2009):

Outcome (per year) Aspirin Control
Serious vascular events 6.7% 8.2%
Total stroke 2.08% 2.54%
Coronary events 4.3% 5.3%

All three reductions were statistically significant. Hemorrhagic stroke rose slightly, but not significantly. The authors described the net benefit for people with existing occlusive vascular disease as definite and substantial.

Primary prevention before 2018

The same ATT analysis pooled 6 primary prevention trials with about 95,000 low-risk people. Aspirin produced a 12% proportional reduction in serious vascular events, but the absolute change was small: 0.51% vs 0.57% per year (ATT Collaboration, Lancet 2009).

  • The benefit came mainly from fewer non-fatal heart attacks (0.18% vs 0.23% per year).
  • Vascular deaths did not differ (0.19% vs 0.19% per year).
  • Major gastrointestinal and other extracranial bleeds rose (0.10% vs 0.07% per year).

The authors concluded that in primary prevention the net value of aspirin was uncertain, because the fall in clotting events had to be weighed against the rise in major bleeds.

The three 2018 trials: ASPREE, ARRIVE and ASCEND

Three large placebo-controlled trials, each using 100 mg/day, reported in 2018:

Trial Population n Follow-up Cardiovascular result Bleeding result
ASPREE Healthy adults 70 or older (65 or older for US Black and Hispanic participants) 19,114 Median 4.7 yr CVD 10.7 vs 11.3 per 1000 person-years; HR 0.95 (95% CI 0.83–1.08) Major hemorrhage 8.6 vs 6.2 per 1000 person-years; HR 1.38 (95% CI 1.18–1.62)
ARRIVE Men 55 or older and women 60 or older at moderate estimated risk; no diabetes 12,546 Median 60 months Primary composite 4.29% vs 4.48%; HR 0.96 (95% CI 0.81–1.13) GI bleeding 0.97% vs 0.46%; HR 2.11 (95% CI 1.36–3.28)
ASCEND Adults with diabetes, no known CVD 15,480 Mean 7.4 yr Serious vascular events 8.5% vs 9.6%; rate ratio 0.88 (95% CI 0.79–0.97) Major bleeding 4.1% vs 3.2%; rate ratio 1.29 (95% CI 1.09–1.52)

Sources: McNeil et al., NEJM 2018 (ASPREE); Gaziano et al., Lancet 2018 (ARRIVE); ASCEND Study Collaborative Group, NEJM 2018.

What each trial adds:

  • ASPREE found no cardiovascular benefit and more major bleeding in healthy older adults. Its primary end point, survival free of dementia and disability, was unchanged (HR 1.01, 95% CI 0.92–1.11), and the trial was stopped early once it was clear that continuing would not show a benefit (McNeil et al., NEJM 2018).
  • ARRIVE saw far fewer events than expected, so the authors said it effectively studied a low-risk population and could not settle the question for moderate risk. The trial was funded by Bayer (Gaziano et al., Lancet 2018).
  • ASCEND was the only one of the three with a significant cardiovascular benefit. The authors concluded that the absolute benefit was largely offset by the extra bleeding (ASCEND, NEJM 2018).

Mortality and long-term follow-up in ASPREE

ASPREE also reported a small, unexpected rise in deaths from any cause: 12.7 vs 11.1 per 1000 person-years (HR 1.14, 95% CI 1.01–1.29). Cancer deaths drove most of the difference (3.1% vs 2.3%; HR 1.31, 95% CI 1.10–1.56). The investigators cautioned that this finding was unexpected given earlier studies and should be interpreted with caution (McNeil et al., NEJM 2018).

The observational extension, ASPREE-XT, followed 15,633 participants for a further median of 4.3 years after the trial ended (Shah et al., Lancet Healthy Longev 2025). Across almost a decade:

  • there was still no effect on survival free of dementia and disability (HR 1.01, 95% CI 0.95–1.08);
  • the effect on all deaths was no longer significant (HR 1.06, 95% CI 0.99–1.14);
  • major hemorrhage remained higher in the original aspirin group (HR 1.24, 95% CI 1.10–1.39).

Meta-analysis including the 2018 trials

A 2019 meta-analysis pooled 13 primary prevention trials with 164,225 participants (Zheng and Roddick, JAMA 2019):

Outcome Aspirin vs no aspirin Absolute change Number needed
CV death, non-fatal MI or non-fatal stroke HR 0.89 (95% credible interval 0.84–0.95) 0.38% lower 265 to prevent one event
Major bleeding HR 1.43 (95% credible interval 1.30–1.56) 0.47% higher 210 to cause one bleed

In other words, across these trials the absolute rise in major bleeding was slightly larger than the absolute fall in cardiovascular events.

Dose and body size

The ADAPTABLE trial randomized 15,076 patients with established atherosclerotic disease to 81 mg or 325 mg daily in an open-label, pragmatic design (Jones et al., NEJM 2021):

Outcome (median 26.2 months) 81 mg 325 mg Hazard ratio
Death, MI or stroke hospitalization 7.28% 7.51% 1.02 (95% CI 0.91–1.14)
Hospitalization for major bleeding 0.63% 0.60% 1.18 (95% CI 0.79–1.77)

Many patients assigned to 325 mg switched dose (41.6% vs 7.1%), which limits the comparison. The trial found no significant difference between the doses.

An individual-patient analysis of 10 primary prevention trials (117,279 participants) looked at body weight (Rothwell et al., Lancet 2018). Aspirin at 75–100 mg reduced cardiovascular events in people weighing 50–69 kg (HR 0.75, 95% CI 0.65–0.85), but not in those weighing 70 kg or more (HR 0.95, 95% CI 0.86–1.04). This was a secondary analysis, not a trial designed to test dosing by weight. The authors concluded that a one-dose-fits-all approach is unlikely to be optimal.

Guideline position: the 2022 USPSTF recommendation

The USPSTF updated its 2016 advice in April 2022 (USPSTF, JAMA 2022; USPSTF recommendation page). It applies to adults 40 or older who have no known cardiovascular disease and are not at increased risk of bleeding.

Group Grade Recommendation
Ages 40–59 with 10-year CVD risk of 10% or more C Starting low-dose aspirin should be an individual decision; the net benefit is small
Ages 60 and older D Recommends against starting aspirin for primary prevention

The Task Force also stated that:

  • 81 mg/day is a reasonable dose for people who start aspirin;
  • it may be reasonable to consider stopping around age 75, because net benefit shrinks with age as bleeding risk rises;
  • the evidence on colorectal cancer prevention is unclear;
  • people already taking aspirin should not stop without talking to their clinician.

The recommendation does not cover people who already have cardiovascular disease, for whom the labeled secondary prevention uses apply.

Aspirin in testosterone and anabolic steroid users

Why the question comes up

Testosterone raises hematocrit (the share of blood made up of red cells), and several sources link testosterone to clotting events:

  • Label. The Depo-Testosterone label lists polycythemia (an abnormally high red cell count) and venous thromboembolism among adverse reactions. It reports postmarketing cases of deep vein thrombosis and pulmonary embolism and says hemoglobin and hematocrit should be checked periodically on long-term therapy (Depo-Testosterone label).
  • TRAVERSE. In this randomized trial of 5,246 hypogonadal men aged 45–80 with existing or high risk of cardiovascular disease, given testosterone gel or placebo, major cardiac events were not increased, but pulmonary embolism, atrial fibrillation and acute kidney injury were more frequent with testosterone (Lincoff et al., NEJM 2023).
  • Erythrocytosis. In a large health-records study, men on testosterone therapy who developed a hematocrit of 52% or more had more major cardiovascular events or venous thromboembolism in the first year than matched men whose hematocrit stayed normal: 5.15% vs 3.87% (OR 1.35, 95% CI 1.13–1.61). This was an observational analysis, not a trial (Ory et al., J Urol 2022).

People using anabolic steroids outside medicine have adopted aspirin themselves. In a qualitative interview study of gay, bisexual and queer men using anabolic steroids, recruited in New York City and through social media, participants described taking aspirin, statins, blood pressure drugs and other medicines without a prescription, along with donating blood and self-ordered hematocrit tests, as harm-reduction steps. The authors noted that research is needed on whether any of these steps helps (Kutscher et al., Harm Reduct J 2024).

What the evidence does not show

We found no randomized trial of aspirin in men on testosterone therapy or in anabolic steroid users. None of the trials above enrolled these groups as such, so there is no direct evidence that aspirin lowers their rate of clots, heart attacks or strokes.

Does aspirin “thin” thick blood? No source reviewed here shows that aspirin lowers hematocrit or red cell count. Its labeled action is on platelet COX-1. A high hematocrit is managed in testosterone guidelines by monitoring it, and the Endocrine Society lists elevated hematocrit as a reason not to start therapy (Bhasin et al., JCEM 2018).

Hematology reviews of non-cancerous erythrocytosis, a category that includes drug-induced cases such as testosterone, take a cautious position:

  • One states there are currently no evidence-based treatment guidelines. It says low-dose aspirin and/or phlebotomy “might be considered” case by case when a person has hyperviscosity symptoms, cardiovascular disease or a history of thrombosis (Szuber et al., Hematology ASH Educ Program 2025).
  • A companion review advises cardiovascular risk optimization and low-dose aspirin, and calls for prospective studies to clarify what harm this kind of erythrocytosis actually causes (Gangat et al., Am J Hematol 2025).

These are expert opinions, not trial results. The bleeding risks described below apply to steroid and testosterone users just as they do to anyone else, and the primary prevention trials show how easily that risk can cancel out a small benefit.

Side effects and risks

Bleeding

Bleeding is the main risk. Across primary prevention trials, aspirin raised major bleeding by roughly 40% in relative terms (HR 1.43) (Zheng and Roddick, JAMA 2019). Absolute rates depend on age and baseline risk:

Setting Major bleeding, aspirin vs placebo
ASPREE (healthy, 70 and older) 8.6 vs 6.2 per 1000 person-years
ASCEND (diabetes) 4.1% vs 3.2% over 7.4 years
ARRIVE (moderate risk) GI bleeding 0.97% vs 0.46% over about 5 years

The ATT analysis found that the main coronary risk factors were also risk factors for bleeding. Hemorrhagic stroke was slightly more common with aspirin in primary prevention (0.04% vs 0.03% per year, p = 0.05) (ATT Collaboration, Lancet 2009). The USPSTF notes that the extra bleeding appears soon after starting aspirin and that bleeding risk rises with age.

The OTC label says the chance of severe stomach bleeding is higher in people who (DailyMed, 81 mg OTC label):

  • are 60 or older;
  • have had stomach ulcers or bleeding problems;
  • take an anticoagulant or a steroid drug;
  • take other NSAIDs;
  • have 3 or more alcoholic drinks every day.

Who should not take it

The professional labeling lists these contraindications and warnings (21 CFR 343.80):

  • NSAID allergy and the asthma–rhinitis–nasal polyp syndrome. Aspirin may cause severe hives, angioedema or bronchospasm.
  • Children and teenagers with viral illness, because of the risk of Reye’s syndrome.
  • Bleeding disorders, such as hemophilia, liver disease or vitamin K deficiency, since even low doses prolong bleeding time.
  • Active peptic ulcer disease.
  • Severe kidney failure (glomerular filtration rate under 10 mL/min) or severe liver insufficiency.

The labels also warn against use in the last 3 months of pregnancy, unless directed by a doctor, because of possible harm to the fetus and complications during delivery (DailyMed, 81 mg OTC label; Durlaza label).

Interactions

Drug or substance Effect reported in labeling or trials
Ibuprofen Ibuprofen 400 mg once daily taken before aspirin, or three times daily, blocked aspirin’s platelet inhibition; acetaminophen, rofecoxib and diclofenac did not (Catella-Lawson et al., NEJM 2001). The Durlaza label advises taking ibuprofen at least 2–4 h after aspirin, or waiting 8 h after ibuprofen before aspirin
Other NSAIDs More bleeding and possible reduced kidney function; the labeling says concurrent use should be avoided
Anticoagulants (warfarin, heparin) and other antiplatelets Higher bleeding risk; aspirin can displace warfarin from protein binding
Alcohol Bleeding risk with 3 or more drinks a day
Methotrexate Salicylate reduces its renal clearance, risking bone marrow toxicity
Phenytoin, valproic acid Protein-binding displacement changes their levels
ACE inhibitors, beta blockers, diuretics Their blood pressure or diuretic effects may be reduced
Acetazolamide Can reach toxic levels

Sources for the table: 21 CFR 343.80; Durlaza label.

Separately, the testosterone cypionate label states that androgens may increase sensitivity to oral anticoagulants and lists bleeding in patients on anticoagulant therapy (Depo-Testosterone label). That warning concerns warfarin-type anticoagulants, not aspirin. See the testosterone cypionate page.

Other effects

The professional labeling lists stomach pain, heartburn, nausea, vomiting and GI bleeding, and notes that minor upper-GI symptoms such as indigestion are common. It also lists rises in liver enzymes, blood urea nitrogen, creatinine and potassium. Ringing in the ears (tinnitus) is an early sign of salicylate excess, at plasma levels of about 200 µg/mL (21 CFR 343.80).

  • US. Aspirin is sold over the counter; the extended-release capsule Durlaza is prescription-only.
  • Sport. Aspirin and salicylates do not appear on the WADA 2026 Prohibited List.

Other cardiovascular drugs covered in the library include atorvastatin, rosuvastatin, telmisartan and fish oil.

Key takeaways

  • Clear benefit after a heart attack or stroke. In secondary prevention, aspirin cut serious vascular events from 8.2% to 6.7% per year, and all labeled vascular uses are in this setting.
  • Small or no net benefit in healthy people. ASPREE and ARRIVE showed no significant cardiovascular benefit, and ASCEND’s benefit was largely offset by bleeding.
  • Bleeding is the trade-off. Major bleeding rose by about 40% in primary prevention trials, and 210 people needed treatment to cause one major bleed versus 265 to prevent one event.
  • USPSTF 2022. Starting aspirin is an individual decision at ages 40–59 with 10% or higher 10-year risk, and is not recommended from age 60.
  • No trial in testosterone or steroid users. Testosterone is linked to raised hematocrit and clotting events, but no source shows aspirin lowers hematocrit or prevents events in this group.

Sources

  1. Food and Drug Administration. Professional labeling for OTC aspirin. 21 CFR 343.80. eCFR.
  2. New Haven Pharmaceuticals. Durlaza (aspirin) extended-release capsules, prescribing information. DailyMed.
  3. Adult Low Dose Aspirin 81 mg delayed-release tablets, Drug Facts label. DailyMed.
  4. National Center for Biotechnology Information. Aspirin, PubChem CID 2244. PubChem.
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  7. McNeil JJ, Woods RL, Nelson MR, et al. Effect of aspirin on disability-free survival in the healthy elderly. N Engl J Med. 2018;379(16):1499–1508. PubMed.
  8. McNeil JJ, Nelson MR, Woods RL, et al. Effect of aspirin on all-cause mortality in the healthy elderly. N Engl J Med. 2018;379(16):1519–1528. PubMed.
  9. Shah RC, Ryan J, Webb KL, et al. Aspirin and healthy lifespan in older people: main outcome of the ASPREE-XT observational study. Lancet Healthy Longev. 2025;6(9):100764. PubMed.
  10. Gaziano JM, Brotons C, Coppolecchia R, et al. Use of aspirin to reduce risk of initial vascular events in patients at moderate risk of cardiovascular disease (ARRIVE): a randomised, double-blind, placebo-controlled trial. Lancet. 2018;392(10152):1036–1046. PubMed.
  11. ASCEND Study Collaborative Group; Bowman L, Mafham M, Wallendszus K, et al. Effects of aspirin for primary prevention in persons with diabetes mellitus. N Engl J Med. 2018;379(16):1529–1539. PubMed.
  12. Zheng SL, Roddick AJ. Association of aspirin use for primary prevention with cardiovascular events and bleeding events: a systematic review and meta-analysis. JAMA. 2019;321(3):277–287. PubMed.
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  17. Pfizer. Depo-Testosterone (testosterone cypionate) injection, prescribing information. DailyMed.
  18. Lincoff AM, Bhasin S, Flevaris P, et al. Cardiovascular safety of testosterone-replacement therapy. N Engl J Med. 2023;389(2):107–117. PubMed.
  19. Ory J, Nackeeran S, Balaji NC, et al. Secondary polycythemia in men receiving testosterone therapy increases risk of major adverse cardiovascular events and venous thromboembolism in the first year of therapy. J Urol. 2022;207(6):1295–1301. PubMed.
  20. Bhasin S, Brito JP, Cunningham GR, et al. Testosterone therapy in men with hypogonadism: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2018;103(5):1715–1744. PubMed.
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  24. World Anti-Doping Agency. World Anti-Doping Code International Standard: Prohibited List 2026. WADA 2026 Prohibited List.