This grade answers one narrow question: how strong is the public evidence and safety record behind this drug, and how clean is its money trail and court record? It is not a verdict on whether the drug is right for you.
Listed on the WHO Model List of Essential Medicines (antibiotic stewardship group: KeyAccessGroup, AccessGroup): a global expert panel judged it among the medicines a health system should always have, on evidence of value, not marketing.
Doxycycline hyclate delayed-release tablets are a tetracycline-class drug indicated for: Rickettsial infections ( 1.1 ) Sexually transmitted infections ( 1.2 ) Respiratory tract infections ( 1.3 ) Specific bacterial infections ( 1.4 ) Ophthalmic infections ( 1.5 ) Anthrax, including inhalational anthrax (post-exposure) ( 1.6 ) Alternative treatment for selected infections when penicillin is contraindicated ( 1.7 ) Adjunctive therapy in acute intestinal amebiasis and severe acne ( 1.8 ) Prophylaxis of malaria ( 1.9 ) Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline hyclate delayed-release tablets and other antibacterial drugs, Doxycycline hyclate delayed-release tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. ( 1.10 ) 1.1 Rickettsial Infections Doxycycline hyclate delayed-release tablets are indicated for treatment of Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by Rickettsiae . 1.2 Sexually Transmitted Infections Doxycycline hyclate delayed-release tablets are indicated for treatment of...
Doxycycline hyclate delayed-release tablets are contraindicated in persons who have shown hypersensitivity to any of the tetracyclines. Doxycycline hyclate delayed-release tablets are contraindicated in persons who have shown hypersensitivity to any of the tetracyclines. ( 4 )
The use of drugs of the tetracycline-class during tooth development (last half of pregnancy, infancy and childhood to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown). ( 5.1 ) Clostridioides difficile -associated diarrhea (CDAD) has been reported: Evaluate patients if diarrhea occurs. ( 5.2 ) Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines. Limit sun exposure. ( 5.3 ) Overgrowth of non-susceptible organisms, including fungi, may occur. If such infections occur, discontinue use and institute appropriate therapy. ( 5.4 ) 5.1 Tooth Development The use of drugs of the tetracycline-class during tooth development (last half of pregnancy, infancy and childhood to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown). This adverse reaction is more common during long-term use of the drugs but it has been observed following repeated short-term courses. Enamel hypoplasia has also been reported. Use doxycycline hyclate delayed-release tablets in pediatric patients 8 years of age or less only when the potential benefits are expected to outweigh the ris...
Adverse reactions observed in patients receiving tetracyclines include anorexia, nausea, vomiting, diarrhea, rash, photosensitivity, urticaria, and hemolytic anemia. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Mayne Pharma at 1-844-825-8500 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trial Experience The safety and efficacy of doxycycline hyclate delayed-release tablets, 200 mg as a single daily dose was evaluated in a multicenter, randomized, double-blind, active-controlled study. Doxycycline hyclate delayed-release tablets, 200 mg was given orally once-a-day for 7 days and compared to doxycycline hyclate capsules 100 mg given orally twice daily for 7 days for the treatment of men and women with uncomplicated urogenital C. trachomatis infection. Adverse reactions in the Safety Population were reported by 99 (40.2%) subjects in the doxycycline hyclate delayed-release tablets, 200 mg treatment group and 132 (53.2%) subjects in the doxycycline hyclate capsules reference treatment group. Most adverse reactions were mild in intensity. The most commonly reported adverse reactions in both treatment groups were nausea, vomiting, diarrhea, and bacterial vaginit...
Warnings and Precautions, Severe Skin Reactions ( 5.5 ) 03/2025
Source: FDA SPL label for Doxycycline Hyclate (Mayne Pharma Commercial LLC), effective 20250414. Full label on DailyMed.
These are counts of reports people filed, not rates of harm. Anyone can file one, and nobody checks whether the drug was the cause. Millions of doses are taken for every report sent, so the useful part is how this drug compares with the average across all drugs.
| 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 | 2026 |
|---|---|---|---|---|---|---|---|
| 6,674 | 6,165 | 5,105 | 5,255 | 5,846 | 5,158 | 6,854 | 3,168 |
1,752 reports blaming this drug for every million Medicare prescriptions filled, which is 0.6× the typical drug on this site. (15,093 reports in 2024–2026, against 8,616,947 Medicare fills in one year. This is the one number here that accounts for how many people take the drug.)
Source: the FDA's Adverse Event Reporting System (FAERS). Reports are voluntary and unverified. Drugs that are prescribed a lot, in the news, or in lawsuits attract more reports, so the percentages are compared with the whole database to correct for that partly, not fully.
| Date | Class | Firm | Reason |
|---|---|---|---|
| 09/2025 | Class II | Acella Pharmaceuticals, LLC | Failed dissolution specifications: Stability testing found that the lot did not meet dissolution specifications. |
| 04/2022 | Class II | Mckesson Medical-Surgical Inc. Corporate Office | cGMP deviations: Temperature abuse |
| 04/2022 | Class II | Mckesson Medical-Surgical Inc. Corporate Office | cGMP deviations: Temperature abuse |
| 01/2022 | Class II | CARDINAL HEALTHCARE | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. |
| 05/2020 | Class II | The Harvard Drug Group | Failed Dissolution Specification: The dissolution test at the 24 month time point (end of shelf life) yielded an out-of-specification result. |
| 05/2020 | Class II | American Health Packaging | Failed dissolution specification - dissolution results of 59% (spec. NLT 85%) at the 24 month time point (end of shelf life). |
| 05/2020 | Class II | PD-Rx Pharmaceuticals, Inc. | Failed dissolution specifications |
| 05/2020 | Class II | West-Ward Columbus Inc | Failed dissolution specification: The dissolution test at the 24 month time point (end of shelf life) yielded an out of specification result. |
| 03/2020 | Class II | Sun Pharmaceutical Industries, Inc. | CGMP Deviations: Doxycycline capsules were not manufactured under Current Good Manufacturing Practice conditions. |
| 03/2020 | Class II | Sun Pharmaceutical Industries, Inc. | CGMP Deviations: Doxycycline capsules were not manufactured under Current Good Manufacturing Practice conditions. |
| 08/2018 | Class II | PD-Rx Pharmaceuticals, Inc. | Failed Dissolution Specifications: manufacturer West-Ward Pharm Corp. recalled these repackaged lots due to failed dissolution results. |
| 08/2018 | Class II | American Health Packaging | Failed Dissolution Specifications: Out of specification result for the dissolution test. |
Class I = reasonable probability of serious harm. Class II = temporary or reversible harm. Class III = unlikely to harm. Most generic recalls are manufacturing or labeling defects for one lot, not a verdict on the molecule.
Counts measure how much evidence exists and how transparent it is, not how big the benefit is. For that, ask your prescriber: if 100 people like me took this, how many would get better because of it, and how many would be harmed? (Doctors call these the "number needed to treat" and "number needed to harm.") It differs by condition and is the number drug ads leave out. Sources: PubMed, ClinicalTrials.gov.
In 2024, drug companies reported $10,344 in payments to US physicians and hospitals tied to this drug across 630 transactions (Oracea $10,344).
No pending federal MDL names this drug or its brands.
Not named in any federal pharmaceutical settlement of $100M or more on record.
Sources: CMS Open Payments (Sunshine Act); Judicial Panel on Multidistrict Litigation pending docket list; DOJ settlements as tabulated on Wikipedia with links to the primary record. State-court and individual suits are not included.
| Product | Fills | $/fill |
|---|---|---|
| Doxycycline Hyclate | 6,667,052 | $12 |
| Doxycycline Monohydrate | 1,931,472 | $16 |
| Doxycycline Ir-Dr | 14,645 | $862 |
| Oracea | 2,605 | $1,245 |
| Doxy 100 | 895 | $237 |
| Doryx Mpc | 244 | $999 |
| Vibramycin | 20 | $20 |
| Targadox | 14 | $549 |
Same ATC pharmacological class, graded ones first, best grade at the top. Being in the same class does not make them interchangeable for your condition; it makes them worth asking about.