Minocycline hydrochloride

What Minocycline hydrochloride is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

Minocycline hydrochloride capsules, USP are indicated in the treatment of the following infections due to susceptible strains of the designated microorganisms: Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox and tick fevers caused by rickettsiae. Respiratory tract infections caused by Mycoplasma pneumoniae. Lymphogranuloma venereum caused by Chlamydia trachomatis. …

— FDA label: Minocycline Hydrochloride, Torrent Pharmaceuticals Limited, effective April 2, 2026. Read the full label on DailyMed →

Label quoted: the one for the most common form (capsule, oral), Minocycline Hydrochloride, Torrent Pharmaceuticals Limited; it covers 3 products in the FDA NDC Directory. The side effects, interactions, dosage and pregnancy quotes below come from this same label.

The FDA has 73 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

Boxed warning

A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.

The label quoted above has no boxed warning.

0 of 73 FDA labels for this medicine have a boxed warning.

Minocycline hydrochloride side effects

Quoted from the “Adverse Reactions” section of the FDA-approved label. Tell your doctor about any side effect that worries you.

Due to oral minocycline’s virtually complete absorption, side effects to the lower bowel, particularly diarrhea, have been infrequent. The following adverse reactions have been observed in patients receiving tetracyclines: Body as a whole: Fever and discoloration of secretions.

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Gastrointestinal: Anorexia, nausea, vomiting, diarrhea, dyspepsia, stomatitis, glossitis, dysphagia, enamel hypoplasia, enterocolitis, pseudomembranous colitis, pancreatitis, inflammatory lesions (with monilial overgrowth) in the oral and anogenital regions. Instances of esophagitis and esophageal ulcerations have been reported in patients taking the tetracycline-class antibiotics in capsule and tablet form. Most of these patients took the medication immediately before going to bed (see DOSAGE AND ADMINISTRATION). Genitourinary: Vulvovaginitis. Hepatic toxicity: Hyperbilirubinemia, hepatic cholestasis, increases in liver enzymes, fatal hepatic failure, and jaundice. Hepatitis, including autoimmune hepatitis, and liver failure have been reported (see PRECAUTIONS). Skin: Alopecia, erythema nodosum, hyperpigmentation of nails, pruritus, toxic epidermal necrolysis, vasculitis, maculopapular rash and erythematous rash. Exfoliative dermatitis has been reported. Fixed drug eruptions have been reported. Lesions occurring on the glans penis have caused balanitis. Erythema multiforme and Stevens-Johnson syndrome have been reported. Photosensitivity is discussed above (see WARNINGS-Photosensitivity). Pigmentation of the skin and mucous membranes has been reported. Respiratory: Cough, dyspnea, bronchospasm, exacerbation of asthma, and pneumonitis. Renal toxicity: Interstitial nephritis. Elevations in BUN have been reported and are apparently dose related (see WARNINGS). Reversible acute renal failure has been reported. Musculoskeletal: Arthralgia, arthritis, bone discoloration, myalgia, joint stiffness, and joint swelling. Hypersensitivity reactions: Urticaria, angioneurotic edema, polyarthralgia, anaphylaxis/anaphylactoid reaction (including shock and fatalities), anaphylactoid purpura, myocarditis, pericarditis, exacerbation of systemic lupus erythematosus and pulmonary infiltrates with eosinophilia have been reported. A transient lupus-like syndrome and serum sickness-like reactions also have been reported. Blood: Agranulocytosis, hemolytic anemia, thrombocytopenia, leukopenia, neutropenia, pancytopenia, and eosinophilia have been reported. Central Nervous System: Convulsions, dizziness, hypesthesia, paresthesia, sedation, and vertigo. Bulging fontanels in infants and benign intracranial hypertension (pseudotumor cerebri) in adults have been reported (see WARNINGS-Intracranial Hypertension). Headache has also been reported. Other: Thyroid cancer has been reported in the postmarketing setting in association with minocycline products. When minocycline therapy is given over prolonged periods, monitoring for signs of thyroid cancer should be considered.

— FDA label: Minocycline Hydrochloride, Torrent Pharmaceuticals Limited, effective April 2, 2026. This is part of the section. Read the full label on DailyMed →

Minocycline hydrochloride drug interactions

Quoted from the “Drug Interactions” section of the FDA-approved label. Tell your pharmacist about every medicine, vitamin and herbal product you take.

Because tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage. Since bacteriostatic drugs may interfere with the bactericidal action of penicillin, it is advisable to avoid giving tetracycline-class drugs in conjunction with penicillin.

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Absorption of tetracyclines is impaired by antacids containing aluminum, calcium, or magnesium, and iron-containing preparations. Concurrent use of tetracyclines with oral contraceptives may render oral contraceptives less effective. Administration of isotretinoin should be avoided shortly before, during, and shortly after minocycline therapy. Each drug alone has been associated with pseudotumor cerebri (see WARNINGS). Increased risk of ergotism when ergot alkaloids or their derivatives are given with tetracyclines.

— FDA label: Minocycline Hydrochloride, Torrent Pharmaceuticals Limited, effective April 2, 2026. Read the full label on DailyMed →

Minocycline hydrochloride dosage

Quoted from the “Dosage and Administration” section of the FDA-approved label. Your own dose is the one your doctor prescribes: do not change it on your own.

THE USUAL DOSAGE AND FREQUENCY OF ADMINISTRATION OF MINOCYCLINE DIFFER FROM THAT OF THE OTHER TETRACYCLINES. EXCEEDING THE RECOMMENDED DOSAGE MAY RESULT IN AN INCREASED INCIDENCE OF SIDE EFFECTS. Minocycline hydrochloride capsules may be taken with or without food (see CLINICAL PHARMACOLOGY). Ingestion of adequate amounts of fluids along with capsule and tablet forms of drugs in the tetracycline-class is recommended to reduce the risk of esophageal irritation and ulceration.

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The capsules should be swallowed whole. For Pediatric Patients above 8 Years of Age Usual pediatric dose: 4 mg/kg initially followed by 2 mg/kg every 12 hours, not to exceed the usual adult dose. Adults The usual dosage of minocycline hydrochloride capsules is 200 mg initially followed by 100 mg every 12 hours. Alternatively, if more frequent doses are preferred, two or four 50 mg capsules may be given initially followed by one 50 mg capsule 4 times daily. Uncomplicated gonococcal infections other than urethritis and anorectal infections in men: 200 mg initially, followed by 100 mg every 12 hours for a minimum of 4 days, with post-therapy cultures within 2 to 3 days. In the treatment of uncomplicated gonococcal urethritis in men, 100 mg every 12 hours for 5 days is recommended. For the treatment of syphilis, the usual dosage of minocycline hydrochloride should be administered over a period of 10 to 15 days. Close follow-up, including laboratory tests, is recommended. In the treatment of meningococcal carrier state, the recommended dosage is 100 mg every 12 hours for 5 days. Mycobacterium marinum infections: Although optimal doses have not been established, 100 mg every 12 hours for 6 to 8 weeks have been used successfully in a limited number of cases. Uncomplicated urethral, endocervical, or rectal infection in adults caused by Chlamydia trachomatis or Ureaplasma urealyticum: 100 mg orally, every 12 hours for at least 7 days. Ingestion of adequate amounts of fluids along with capsule and tablet forms of drugs in the tetracycline class is recommended to reduce the risk of esophageal irritation and ulceration. The pharmacokinetics of minocycline in patients with renal impairment (CL CR <80 mL/min) have not been fully characterized. Current data are insufficient to determine if a dosage adjustment is warranted. The total daily dosage should not exceed 200 mg in 24 hours. However, due to the antianabolic effect of tetracyclines, BUN and creatinine should be monitored (see WARNINGS - Antianabolic Action).

— FDA label: Minocycline Hydrochloride, Torrent Pharmaceuticals Limited, effective April 2, 2026. Read the full label on DailyMed →

Minocycline hydrochloride in pregnancy

Quoted from the pregnancy part of the FDA-approved label. Ask your doctor before you take any medicine while pregnant or planning a pregnancy.

Risk Summary All pregnancies have a background risk of birth defects, loss, or other adverse outcome regardless of drug exposure. There are no adequate and well-controlled studies on the use of minocycline in pregnant women. Minocycline, like other tetracycline-class antibiotics, crosses the placenta and may cause fetal harm when administered to a pregnant woman.

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Rare spontaneous reports of congenital anomalies including limb reduction have been reported in postmarketing experience. Only limited information is available regarding these reports; therefore, no conclusion on causal association can be established. If minocycline is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. Nonteratogenic Effects: (see WARNINGS.)

— FDA label: Minocycline Hydrochloride, Torrent Pharmaceuticals Limited, effective April 2, 2026. Read the full label on DailyMed →

Minocycline hydrochloride and breastfeeding

Quoted from the nursing mothers / lactation part of the FDA-approved label.

Tetracyclines are excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from the tetracyclines, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother (see WARNINGS).

— FDA label: Minocycline Hydrochloride, Torrent Pharmaceuticals Limited, effective April 2, 2026. Read the full label on DailyMed →

When Minocycline hydrochloride should not be used

Quoted from the “Contraindications” section of the FDA-approved label.

This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines or to any of the components of the product formulation.

— FDA label: Minocycline Hydrochloride, Torrent Pharmaceuticals Limited, effective April 2, 2026. Read the full label on DailyMed →

Minocycline hydrochloride overdose

Quoted from the “Overdosage” section of the FDA-approved label. If someone may have taken too much, call Poison Help at 1-800-222-1222 (or 911 in an emergency).

The adverse events more commonly seen in overdose are dizziness, nausea, and vomiting. No specific antidote for minocycline is known. In case of overdosage, discontinue medication, treat symptomatically, and institute supportive measures. Minocycline is not removed in significant quantities by hemodialysis or peritoneal dialysis.

— FDA label: Minocycline Hydrochloride, Torrent Pharmaceuticals Limited, effective April 2, 2026. Read the full label on DailyMed →

Forms and how it is given

Companies that list this medicine

Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.

• Bryant Ranch Prepack30 products
• Aurobindo Pharma Limited14 products
• Zydus Pharmaceuticals USA Inc.11 products
• PD-Rx Pharmaceuticals, Inc.11 products
• Zydus Lifesciences Limited11 products
• Ascend Laboratories, LLC8 products
• Torrent Pharmaceuticals Limited6 products
• Proficient Rx LP6 products
• A-S Medication Solutions4 products
• Lupin Pharmaceuticals, Inc.4 products
• Chartwell RX, LLC3 products
• NuCare Pharmaceuticals, Inc.3 products
• Northwind Health Company, LLC3 products
• Strides Pharma Science Limited3 products
• Journey Medical Corporation3 products
• Advanced Rx Pharmacy of Tennessee, LLC2 products
• Remedyrepack Inc.2 products
• Major Pharamceuticals1 product
• OraPharma, Inc.1 product
• Preferred Pharmaceuticals Inc.1 product
• American Health Packaging1 product
• Actavis Pharma, Inc.1 product
• Melinta Therapeutics, LLC1 product

FDA approval history

• NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
• ANDA: Abbreviated New Drug Application: how a generic version is approved.

Generic approvals (15)

• ANDA063065Watson Labs · December 30, 1991
• ANDA063181Watson Labs Teva · December 30, 1991
• ANDA063009Zydus · March 2, 1992
• ANDA063011Zydus · March 2, 1992
• ANDA065062Torrent · November 30, 2000
• ANDA065131Strides Pharma Intl · April 16, 2003
• ANDA065156Torrent · January 6, 2004
• ANDA065436Chartwell Rx · December 26, 2007
• ANDA065470Aurobindo Pharma · March 11, 2008
• ANDA091424Lupin · November 30, 2011
• ANDA202261Aurobindo Pharma Ltd · November 19, 2012
• ANDA090867Sun Pharm Inds Inc · May 13, 2013
• ANDA204453Alkem Labs Ltd · September 28, 2016
• ANDA203553Zydus Pharms · November 16, 2017
• ANDA213662Aurobindo Pharma Ltd · May 1, 2020

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

Recalls

From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.

1. June 1, 2026 · Class II · Ongoing · D-0597-2026

   Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysis

   Minocycline Hydrochloride Extended-Release Tablets, USP, 115 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA. Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054. NDC: 67877-644-3 — Ascend Laboratories, LLC

2. January 22, 2020 · Class III · Terminated · D-0827-2020

   Failed Dissolution Specifications: low out of specification results for dissolution testing.

   Minocycline Hydrochloride Extended-Release Tablets, USP, 105 mg*, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013 India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054 — Ascend Laboratories LLC

Official identifiers

Next steps

• Find a pharmacy near youAsk which price applies to you and whether your product is affected by a recall
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• Bryant Ranch PrepackMaker or distributor
• Aurobindo Pharma LimitedMaker or distributor
• Zydus Pharmaceuticals USA Inc.Maker or distributor
• All prescription drugs A to ZSearch by generic, brand or Spanish name

Sources

1. FDA-approved label on DailyMed (National Library of Medicine) — Minocycline Hydrochloride, Torrent Pharmaceuticals Limited, effective April 2, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
5. Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026

openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →

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