Minocycline hydrochloride adverse reactions

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Minocycline hydrochloride
DYNACIN® FDA Package Insert
Description
Clinical Pharmacology
Microbiology
Indications and Usage
Contraindications
Warnings and Precautions
Adverse Reactions
Overdosage
Dosage and Administration
How Supplied
Labels and Packages

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Mohamed Moubarak, M.D. [2]

Adverse Reactions

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.

Gastrointestinal

Anorexia, nausea, vomiting, diarrhea, glossitis, dysphagia, enterocolitis, pancreatitus, inflammatory lesions (with monilial overgrowth) in the anogenital region, and increases in liver enzymes have been reported. Rarely, hepatitis and liver failure have been reported. These reactions have been caused by both the oral and the parenteral administration of tetracyclines. Rare 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 AND ADMINISTRATION).

Skin

Maculopapular and erythematous rashes. Exfoliative dermatitis has been reported but is uncommon. Fixed drug eruptions have been rarely reported. Lesions occurring on the glans penis have caused balanitis. Erythema multiforme and rarely Stevens-Johnson syndrome have been reported. Photosensitivity is discussed above (see WARNINGS). Pigmentation of the skin and mucous membranes has been reported.

Renal toxicity

Elevations in BUN have been reported and are apparently dose related (see WARNINGS). Acute renal failure has been rarely reported and, in most cases, has been reversible.

Hypersensitivity reactions

Urticaria, angioneurotic edema, polyarthralgia, anaphylaxis, anaphylactoid purpura, pericarditis, exacerbation of systemic lupus erythematosus and rarely pulmonary infiltrates with eosinophilia have been reported. A lupus-like syndrome and serum sickness-like reactions also have been reported.

Blood

Hemolytic anemia, thrombocytopenia, neutropenia, and eosinophilia have been reported.

Central Nervous System

Bulging fontanels in infants and benign intracranial hypertension (pseudotumor cerebri) in adults (see PRECAUTIONS-General) have been reported. Headache has also been reported.

Other

When given over prolonged periods, tetracyclines have been reported to produce brown-black microscopic discoloration of the thyroid glands. Very rare cases of abnormal thyroid function have been reported.

Tooth discoloration in pediatric patients less than 8 years of age (see WARNINGS) and also, rarely, in adults has been reported.

Tinnitus and decreased hearing have been rarely reported in patients on minocycline hydrochloride.[1]

References

  1. "DYNACIN (MINOCYCLINE HYDROCHLORIDE) CAPSULE [MEDICIS, THE DERMATOLOGY COMPANY]". Text " accessdate" ignored (help)

Adapted from the FDA Package Insert.