Minocin Kit Side Effects

Please note - some side effects for Minocin Kit may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Minocin Kit - for the Consumer

Minocin Kit

Applies to: capsules; calming wipes

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Minocin Kit:

Diarrhea; dizziness; drowsiness; indigestion; lightheadedness; loss of appetite; nausea; sore mouth, throat, or tongue; stomach upset; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody stools; blurred vision; change in the amount of urine produced; fever, chills, or sore throat; hearing problems; joint pain; muscle pain or weakness; rectal or genital irritation; red, swollen, blistered, or peeling skin; ringing in the ears; seizures; severe or persistent headache; severe, watery diarrhea; severe skin reaction to the sun; stomach pain or cramps; swollen glands; symptoms of pancreatitis (eg, severe stomach or back pain with or without nausea or vomiting); trouble swallowing; unusual bruising or bleeding; unusual tiredness or weakness; vaginal irritation or discharge; white patches in the mouth; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Side Effects by Body System - for Healthcare Professionals

Applies to: intravenous powder for injection; oral capsule; oral suspension; oral tablet; oral tablet, extended release; oral and topical kit

Gastrointestinal

Gastrointestinal side effects have included abdominal cramping, anorexia, diarrhea, dyspepsia, dysphagia, enamel hypoplasia, enterocolitis, esophagitis, esophageal ulcerations, glossitis, nausea, oral cavity and tooth discoloration, inflammatory lesions (with monilial overgrowth) in the oral and anogenital regions, pancreatitis, pseudomembranous colitis, stomatitis, vomiting, and dry mouth.

Pancreatitis has rarely been reported in association with minocycline use. Two case reports of cystic fibrosis patients who experienced pancreatitis while being treated with minocycline for acute bacterial exacerbations of respiratory disease have been published in the medical literature. The authors suggested that cystic fibrosis patients, as a result of the disease process, may be more susceptible to drug-induced pancreatitis. Additionally, in at least one case, multiple medications were being given concomitantly; therefore, a temporal relationship between minocycline and pancreatitis could not be proven conclusively.

Esophagitis and esophageal ulcerations have been reported in patients taking the capsule or tablet formulations of tetracycline-class antibiotics. Most of these patients took the drug immediately before going to bed.

Nervous system

Nervous system side effects have included convulsions, headache, hypesthesia, paresthesia, sedation, vestibular reactions including dizziness and vertigo. Decreased hearing, tinnitus, benign intracranial hypertension (pseudotumor cerebri) in adults, and bulging fontanels in infants have been reported.

Hepatic

In one reported case, a patient developed rapidly progressing liver failure after four weeks of minocycline therapy for acne. The patient had discontinued the medication two weeks prior to onset of malaise. Liver transplantation was considered, although the patient slowly recovered without significant intervention.

Other reports of immunologically-mediated progressive liver dysfunction have rarely occurred. In one case, a patient received a liver transplant following fulminant hepatic failure which was thought to be related to a 3 year history of daily minocycline therapy to treat acne. The dose of minocycline ranged from 50 mg to 200 mg per day. A second patient had been receiving minocycline therapy to treat acne for 1 year just prior to seeking medical attention for a "flu-like" syndrome. Upon hospitalization, it was determined that the patient was experiencing an autoimmune-mediated hepatitis, most probably related to minocycline. Resolution of symptoms occurred in both of these cases after minocycline therapy was discontinued and each patient had received appropriate supportive medical care.

Hepatic side effects have included hyperbilirubinemia, hepatic cholestasis, increased liver enzymes, fatal hepatic failure, jaundice, hepatitis (including autoimmune hepatitis), and liver failure.

Hypersensitivity

Hypersensitivity side effects have included anaphylactoid purpura, anaphylaxis/anaphylactoid reaction (including shock and fatalities), angioneurotic edema, autoimmune vasculitis, drug fever, eosinophilic pneumonitis, erythema multiforme, fixed drug eruptions, hepatitis, lupus-like syndrome, myocarditis, pericarditis, polyarthralgia, pulmonary infiltrates with eosinophilia, rhabdomyolysis, serum sickness, serum sickness-like reactions, Stevens-Johnson syndrome, urticaria, and severe central nervous system-pulmonary hypersensitivity syndrome. Drug rash with eosinophilia and systemic symptoms (DRESS) including fatal cases have been reported. DRESS syndrome with persistent myocarditis has been reported in at least 3 cases. 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) has been reported. Fever and lymphadenopathy may be present with hypersensitivity syndrome. Death has been reported in some cases involving hypersensitivity syndrome.

Pulmonary infiltrates, night sweats, fever and eosinophilia have developed in several patients receiving minocycline. These effects were also thought to be due to hypersensitivity to minocycline.

Case reports have described a severe central nervous system-pulmonary hypersensitivity syndrome requiring high-dose corticosteroid therapy. Signs and symptoms have included dry cough, fever, ataxia, muscle weakness, numbness, visual abnormalities, abnormal brain MRI, seizures, pulmonary infiltrates, elevated serum IgE and erythrocyte sedimentation rate, and eosinophilia.

Eosinophilic pneumonia with relapsing acute respiratory failure requiring mechanical ventilation and corticosteroids has been reported in a 54-year-old woman. Initial symptoms included dry cough, low-grade fever, fatigue, and dyspnea. Eosinophilia, elevated leukocytes, and C-reactive protein were noted. Fourteen days after being discharged and resuming minocycline, the patient developed rapidly progressive respiratory failure again requiring mechanical ventilation.

Late-onset drug fever (associated with fever, sore throat, abdominal pain, weakness, loose bloody stools, fatigue, 40-pound weight loss, ESR 99 mm/hr, CRP 5.0 mg/dL, and mild increases in liver enzymes) has been reported in a 15-year-old boy after 24 months of minocycline therapy for acne. One other case of late-onset drug fever occurred after 1 year of treatment. Other reported cases of drug fever generally occurred after 2 to 4 weeks of minocycline exposure.

Immunologic

Lupus-like reactions induced by minocycline have commonly presented with arthralgia or arthritis, myalgia or malaise, and positive ANA titer. Patients with highly positive anti-dsDNA antibodies have rarely been reported. All patients have recovered following discontinuation of the drug. However, several have required short courses of corticosteroids.

Rare case reports of additional immunologic side effects have included necrotizing vasculitis and systemic reactions characterized by lymphadenopathy, eosinophilia, increased liver function enzyme levels, and dermatologic involvement. In each case, minocycline was discontinued and in some cases, corticosteroid therapy was necessary to assist in the resolution of symptoms.

Immunologic side effects have included positive antineutrophil cytoplasmic antibody (ANCA) titers, exacerbation of systemic lupus, polyarteritis nodosa, ANCA-positive crescentic glomerulonephritis, ANCA-positive vasculitis, and autoimmune hepatitis. Rare cases of necrotizing vasculitis and systemic reactions have been reported. 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) has been reported. Serum sickness-like syndrome (consisting of fever; urticaria or rash; and arthralgia, arthritis, joint stiffness, or joint swelling) has been reported. Eosinophilia may be present with serum sickness-like syndrome. Death has been reported in some cases involving these syndromes.

Dermatologic

Dermatologic side effects have included pruritus, alopecia, erythema multiforme, erythema nodosum, exfoliative dermatitis, fixed drug eruptions, maculopapular and erythematous rashes, photosensitivity, Stevens-Johnson syndrome, toxic epidermal necrolysis, lesions on the glans penis, and vasculitis. Brownish or bluish-black pigmentation of the skin, bones, mucous membranes, teeth, tongue, nail beds, and structures of inner organs have also been reported. Minocycline has rarely been associated with Sweet's syndrome (acute febrile neutrophilic dermatosis).

Biopsies of pigmented tissue have shown granules within the cells which stained positive for iron. This pigmentation may fade over time following drug discontinuation.

There have also been case reports of mucosal pigmentation associated with minocycline use.

Musculoskeletal

Musculoskeletal side effects have included arthralgia, arthritis, bone discoloration, joint discoloration, joint stiffness, joint swelling, myalgia, myopathy, and hypersensitivity-associated rhabdomyolysis.

Severe acute myopathy associated with oral minocycline 100 mg/day occurred in a 17-year-old male after strenuous exercise. His laboratory values were: erythrocyte sedimentation rate, 33 mm/hr; C-reactive protein, 0.84 mg/dL; creatine kinase, 87,297 units/L; AST, 1307 units/L; ALT, 311 units/L; lactate dehydrogenase, 4935 units/L; aldolase 12.6 units/L; alkaline phosphatase, 145 units/L; GGT, 66 units/L. Muscle enzyme levels normalized and his symptoms resolved one month after minocycline was discontinued.

Intravenous minocycline plus quinupristin-dalfopristin were associated with myalgia and arthralgia in 36% of neutropenic cancer patients (n=56).

Renal

Renal side effects have included increased BUN, interstitial nephritis, and acute renal failure. High serum levels of tetracyclines have been associated with azotemia, hyperphosphatemia, and acidosis in renally impaired patients.

Hematologic

Hematologic side effects have included antineutrophil cytoplasmic antibody (ANCA)-positive vasculitis, and eosinophilia. Tetracyclines have been associated with hemolytic anemia, thrombocytopenia, neutropenia, agranulocytosis, leukopenia, and pancytopenia.

Other

Other side effects associated with tetracyclines have included fatigue, malaise, somnolence, fever, and discoloration of secretions.

Respiratory

Respiratory side effects have included hypersensitivity pneumonitis, pulmonary lupus, eosinophilic pneumonia, pleural effusions, and relapsing acute respiratory failure. Tetracyclines have been associated with cough, dyspnea, bronchospasm, pneumonitis, and exacerbation of asthma.

Oncologic

Oncologic side effects have included papillary thyroid cancer. Thyroid cancer has also been reported during postmarketing experience.

Endocrine

Endocrine system side effects have included a condition characterized by dark pigmentation (brown-black microscopic discoloration) of the thyroid gland. However, there was no clinical or laboratory evidence of thyroid dysfunction. The clinical implications of this pigmentation are unknown. Abnormal thyroid function has been reported.

Genitourinary

Genitourinary side effects have included balanitis (due to lesions on the glans penis) and vulvovaginitis. Minocycline may have detrimental effects on spermatogenesis according to preliminary studies.

Local

Local side effects have included erythema and pain at the injection site.

Psychiatric

Psychiatric side effects have included mood alteration.

Ocular

Ocular side effects have included case reports of gray scleral pigmentation and macular pigmentation in elderly patients after chronic minocycline use (5 to 12 years).

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