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.
Minocycline hydrochloride extended-release tablets USP are tetracycline-class drug indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. ( 1 ) 1.1 Indication Minocycline hydrochloride extended-release tablets USP are indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. 1.2 Limitations of Use Minocycline hydrochloride extended-release tablets USP did not demonstrate any effect on non-inflammatory acne lesions. Safety of minocycline hydrochloride extended-release tablets USP have not been established beyond 12 weeks of use. This formulation of minocycline has not been evaluated in the treatment of infections [see CLINICAL STUDIES ( 14 )] To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, minocycline hydrochloride extended-release tablets USP should be used only as indicated [see WARNINGS AND PRECAUTIONS ( 5.11 )]
This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines. ( 4 ) This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.
The use of minocycline hydrochloride extended-release tablets during tooth development (last half of pregnancy, infancy, and childhood up to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown). ( 5.1 ) If pseudomembranous colitis occurs, discontinue minocycline hydrochloride extended-release tablets. ( 5.2 ) If liver injury is suspected, discontinue minocycline hydrochloride extended-release tablets. ( 5.3 ) If renal impairment exists, minocycline hydrochloride extended-release tablets doses may need to be adjusted to avoid excessive systemic accumulations of the drug and possible liver toxicity. ( 5.4 ) Minocycline may cause central nervous system side effects including light-headedness, dizziness, or vertigo. Advise patients. ( 5.5 ) Minocycline may cause pseudotumor cerebri (benign intracranial hypertension) in adults and adolescents. Discontinue minocycline hydrochloride extended-release tablets if symptoms occur. ( 5.6 ) Minocycline has been associated with autoimmune syndromes; discontinue minocycline hydrochloride extended-release tablets immediately if symptoms occur. ( 5.7 ) Minocycline has been associated with anaphylaxis, serious skin r...
The most commonly observed adverse reactions (incidence ≥ 5%) are headache, fatigue, dizziness, and pruritus. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc. at 1-800-399-2561 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug, and may not reflect the rates observed in practice. The following table summarizes selected adverse reactions reported in clinical trials at a rate of ≥1% for minocycline hydrochloride extended-release tablets. Table 2: Selected Treatment-Emergent Adverse Reactions in at least 1% of Clinical Trial Subjects Adverse Reactions Minocycline hydrochloride extended - release tablets ( 1 mg / kg ) N = 674 (%) Placebo N = 364 (%) At least one treatment-emergent event 379 (56) 197 (54) Headache 152 (23) 83 (23) Fatigue 62 (9) 24 (7) Dizziness 59 (9) 17 (5) Pruritus 31 (5) 16 (4) Malaise 26 (4) 9 (3) Mood alteration 17 (3) 9 (3) Somnolence 13 (2) 3 (1) Urticaria 10 (2) 1 (0) Tinnitus 10 (2) 5 (1) ...
Source: FDA SPL label for Minocycline Hydrochloride (Lupin Pharmaceuticals, Inc.), effective 20231030. 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 |
|---|---|---|---|---|---|---|---|
| 1,174 | 1,477 | 1,147 | 1,096 | 1,253 | 1,684 | 1,598 | 511 |
10,736 reports blaming this drug for every million Medicare prescriptions filled, which is 3.9× the typical drug on this site. (3,788 reports in 2024–2026, against 352,832 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 |
|---|---|---|---|
| 06/2026 | Class II | Ascend Laboratories, LLC | Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysis |
| 01/2020 | Class III | Ascend Laboratories LLC | Failed Dissolution Specifications: low out of specification results for dissolution testing. |
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 $243,572 in payments to US physicians and hospitals tied to this drug across 7,205 transactions (Arestin $243,572).
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 |
|---|---|---|
| Minocycline HCl | 350,488 | $26 |
| Zilxi | 901 | $477 |
| Amzeeq | 764 | $482 |
| Minocycline HCl ER | 473 | $257 |
| Minocin | 206 | $3,725 |
2 drugs in the same class grade a letter or more higher than minocycline on this site. Worth asking whether one of them would do the same job for you.
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.