The following adverse reactions have been observed in
patients receiving tetracyclines.
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. These reactions
have been caused by both the oral and parenteral administration of
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, 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.
Local Reactions: Injection site erythema and
injection site pain.
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).
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 lupus-like syndrome and
serum sickness-like reactions also have been reported.
Blood: Agranulocytosis, hemolytic anemia,
thrombocytopenia, leukopenia, neutropenia, pancytopenia, and eosinophilia have
Central Nervous System: Convulsions, dizziness,
hypesthesia, paresthesia, sedation, and vertigo. Pseudotumor cerebri (benign
intracranial hypertension) in adults and bulging fontanels in infants (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 pediatric patients less than 8
years of age (see WARNINGS) and 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®(minocycline for injection).
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.