Minocin PAC Side Effects

Generic Name: minocycline ,minocycline

Please note - some side effects for Minocin PAC may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects by Body System

Gastrointestinal

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.

Gastrointestinal side effects have included abdominal cramping, anorexia, diarrhea, dyspepsia, dysphagia, enamel hypoplasia, enterocolitis, esophagitis and esophageal ulcerations, glossitis, nausea, oral cavity and tooth discoloration, oral and anogenital inflammation and moniliasis, pancreatitis, Pseudomembranous colitis, stomatitis, vomiting, and dry mouth.

Nervous system

Nervous system adverse effects have included headache, hypesthesia, paresthesia, sedation, vestibular reactions such as dizziness and vertigo. Additionally, rare cases of decreased hearing, tinnitus, and benign intracranial hypertension (pseudotumor cerebri), 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, jaundice, autoimmune hepatitis, hepatitis, and liver failure.

Hypersensitivity

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.

Hypersensitivity reactions have included anaphylactoid reactions, anaphylactoid purpura, anaphylaxis (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.

Dermatologic

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.

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, 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, usually occurring during prolonged therapy. Minocycline has rarely been associated with Sweet's syndrome (acute febrile neutrophilic dermatosis).

Endocrine

Endocrine system side effects have included a condition characterized by dark pigmentation 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 rarely been reported.

Immunologic

Immunologic side effects have rarely included positive antineutrophil cytoplasmic antibody (ANCA) titers, exacerbation of systemic lupus, lupus-like syndrome, polyarteritis nodosa, ANCA-positive crescentic glomerulonephritis, ANCA-positive vasculitis, and autoimmune hepatitis.

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.

Musculoskeletal

Musculoskeletal side effects have included arthralgia, arthritis, bone discoloration, joint discoloration, 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/h; 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

Tetracyclines have been associated with fatigue, malaise, somnolence, fever, and discoloration of secretions.

Genitourinary

Genitourinary side effects have included balanitis and vulvovaginitis. Minocycline may have detrimental effects on spermatogenesis according to preliminary studies.

Local

Local reactions have included erythema and pain at the injection site.

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, and exacerbation of asthma.

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).

Psychiatric

Psychiatric side effects have included mood alteration.

Oncologic

Oncologic side effects have included papillary thyroid cancer.

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