Side Effects of Minocin (minocycline)

Minocin (minocycline) is a tetracycline antibiotic used to treat infections caused by

• Mycoplasma pneumonia,
• Chlamydia trachomatis,
• Borrelia recurrentis,
• Yersinia pestis,
• Escherichia coli,
• Enterobacter aerogenes,
• Shigella species,
• Acinetobacter species,
• respiratory tract infections caused by Haemophilus influenza and Streptococcus pneumoniae, and
• respiratory tract and urinary tract infections caused by Klebsiella species. 

Minocin extended-release tablets are used to treat inflammatory lesions of non-nodular moderate-to-severe acne vulgaris. Minocin is used for treating Rocky Mountain spotted fever, typhus and other infections caused by the typhus group of bacteria, Q fever, rickettsialpox and tick fevers caused by rickettsiae.

Common side effects of Minocin include

• nausea,
• vomiting,
• diarrhea,
• headache,
• fatigue,
• dizziness,
• itching,
• photosensitivity, and
• tooth discoloration.

Serious side effects of Minocin include reduced bone development in children.

Drug interactions of Minocin include anticoagulant medications such as warfarin because it can increase the risk of bleeding and bruising.

• Antacids containing aluminum, calcium, magnesium and iron-containing medications can bind with Minocin, delay the absorption, and reduce the effectiveness of Minocin.
• Minocin should be used with caution with oral contraceptives because it may decrease the effectiveness of oral contraceptives. 

Minocin should be avoided in pregnant women because it crosses the placenta and may cause fetal harm. 

Minocin is excreted in human milk, and there is potential for serious adverse effects involving the development of teeth and bones in nursing infants. A decision should be made to discontinue Minocin or stop breastfeeding, taking into account the importance of the drug to the mother.

Side effects of minocycline are:

• nausea,
• vomiting,
• diarrhea,
• headache,
• fatigue,
• dizziness,
• itching,
• photosensitivity,
• tooth discoloration, and
• reduced bone development in children.

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.

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.

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.

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, including balanitis, have been reported. Erythema multiforme and Stevens-Johnson syndrome have been reported. Photosensitivity is discussed above. 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. 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. Pseudotumor cerebri (benign intracranial hypertension) in adults and bulging fontanels in infants. Headache has also been reported.

Other: Thyroid cancer has been reported in the post-marketing setting in association with minocycline products. When minocycline therapy is given over prolonged periods, monitoring for signs of thyroid cancer should be considered.

When given over prolonged periods, tetracyclines have been reported to produce brown-black microscopic discoloration of the thyroid gland. Cases of abnormal thyroid function have been reported.

Tooth discoloration in children less than 8 years of age and also, in adults has been reported.

Oral cavity discoloration (including tongue, lip, and gum) has been reported.

Tinnitus and decreased hearing have been reported in patients on MINOCIN (minocycline hydrochloride).

The following syndromes have been reported. In some cases involving these syndromes, death has been reported. As with other serious adverse reactions, if any of these syndromes are recognized, the drug should be discontinued immediately:

Hypersensitivity syndrome consisting of cutaneous reaction (such as rash or exfoliative dermatitis), eosinophilia, and one or more of the following:

• hepatitis,
• pneumonitis,
• nephritis,
• myocarditis, and
• pericarditis.

Fever and lymphadenopathy may be present.

Lupus-like syndrome consisting of positive antinuclear antibody; arthralgia, arthritis, joint stiffness, or joint swelling; and one or more of the following:

• fever,
• myalgia,
• hepatitis,
• rash, and
• vasculitis.

Serum sickness-like syndrome consisting of fever; urticaria or rash; and arthralgia, arthritis, joint stiffness, or joint swelling and lymphadenopathy. Eosinophilia may be present.

To report SUSPECTED ADVERSE REACTIONS, contact Valeant Pharmaceuticals North America LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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.

Absorption of tetracyclines is impaired by antacids containing aluminum, calcium, or magnesium, and iron-containing preparations.

The concurrent use of tetracycline and methoxyflurane has been reported to result in fatal renal toxicity.

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.

Increased risk of ergotism when ergot alkaloids or their derivatives are given with tetracyclines.