Aspirin 162 mg: clinical trials recruiting now
3
Recruiting trials
8
Conditions studied
15
US states with sites
1
Countries
FDA drug label
- FDA-approved
- Yes. Aspirin 162 mg appears in the FDA drug-label database. Marketed as Low Dose Aspirin.
- Drug class
- Nonsteroidal Anti-inflammatory Drug; Platelet Aggregation Inhibitor (FDA established pharmacologic class)
- Mechanism of action
- Cyclooxygenase Inhibitors (as stated on the FDA label)
FDA-approved use
Uses for the temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief. ask your doctor about other uses for safety coated 81 mg aspirin
FDA recalls / enforcement
| Reason (FDA) | Classification | Status | Initiated |
|---|---|---|---|
| CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. — CARDINAL HEALTHCARE | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2022-01-26 |
| cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity. — Safecor Health, LLC | Class II (FDA: may cause temporary or reversible harm) | Ongoing | 2024-11-11 |
| Labeling: Missing Label - some bottles are missing the the manufacturers label that includes the drug facts information. — Aurobindo Pharma USA Inc | Class I (FDA: reasonable probability of serious harm or death) | Ongoing | 2024-07-11 |
| Failed Tablet/Capsule Specification : Capsule breakage — Glenmark Pharmaceuticals Inc., USA | Class III (FDA: unlikely to cause harm) | Ongoing | 2022-06-29 |
| Labeling: Label Mix-up. This issue affects the outer box labeling only. The box incorrectly states the ingredients Acetaminophen 500mg and Caffeine 65mg. The inner pouch correctly states the ingredients are Aspirin (NSAID)*500mg and Caffeine 32.5mg. — Aero Healthcare | Class II (FDA: may cause temporary or reversible harm) | Ongoing | 2025-10-17 |
Phase breakdown
Phase 3 2
Phase 4 1
Conditions being studied
| Condition | Trials |
|---|---|
| Hypertension | 2 |
| COPD | 1 |
| Gestational Hypertension | 1 |
| Hypertensive Disorders of Pregnancy | 1 |
| Pre-Eclampsia | 1 |
| Preeclampsia | 1 |
| Pregnancy Loss | 1 |
| Pulmonary Disease, Chronic Obstructive | 1 |
Recruiting trials involving Aspirin 162 mg
- APPLE: Aspirin to Prevent Pregnancy Loss and Preeclampsia
- Effectiveness of Two Aspirin Doses for Prevention of Hypertensive Disorders of Pregnancy: ASPIRIN TRIAL
- Trial to Determine Effective Aspirin Dose in COPD
Common questions
Is Aspirin 162 mg FDA-approved?
Yes, marketed as Low Dose Aspirin.
How many recruiting trials involve Aspirin 162 mg?
3 recruiting trials across 8 conditions.
Is this list of trials complete?
No. For the full record, search ClinicalTrials.gov.