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
Body as a whole: Fever, and discoloration of
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
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, and vasculitis.
Maculopapular and erythematous rashes. 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.) 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 PRECAUTIONS - General.) 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
Tooth discoloration in children less than 8 years of age
(see WARNINGS) and also, in adults has been reported.
Oral cavity discoloration (including tongue, lip, and
gum) have been reported.
Tinnitus and decreased hearing have been reported in
patients on MINOCIN.
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
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. 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