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.
Body as a whole: Fever, and discoloration of secretions.
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 AND ADMINISTRATION.)
Genitourinary: Vulvovaginitis.
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 been reported.
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 discontinued immediately:
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.
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REPORTS OF SUSPECTED MINOCIN SIDE EFFECTS / ADVERSE REACTIONS
Below is a sample of reports where side effects / adverse reactions may be related to Minocin. The information is not vetted and should not be considered as verified clinical evidence.
Possible Minocin side effects / adverse reactions in 29 year old female
Reported by a physician from Japan on 2011-10-18
Patient: 29 year old female
Reactions: Hepatic Function Abnormal, Aspartate Aminotransferase Increased, Alanine Aminotransferase Increased, Ocular Icterus, Decreased Appetite
Adverse event resulted in: hospitalization
Suspect drug(s):
Protecadin (Lafutidine)
Dosage: 10 mg; po
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2010-07-26
End date: 2011-07-26
Loratadine
Dosage: 10 mg; qd; po
Administration route: Oral
Indication: Urticaria
Start date: 2011-07-05
End date: 2011-07-26
Minocin
Dosage: 50 mg; po
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2011-05-30
End date: 2011-07-26
Betaselemin (Celestamine 00252801/)
Dosage: 1 df; po
Administration route: Oral
Start date: 2010-07-26
End date: 2011-07-26
Ebastine
Dosage: 10 mg; po
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2010-05-18
End date: 2011-07-26
Possible Minocin side effects / adverse reactions in 76 year old female
Reported by a consumer/non-health professional from Germany on 2012-02-14
Patient: 76 year old female
Reactions: Abdominal Pain, Malaise, Nausea, Hepatitis
Adverse event resulted in: hospitalization
Suspect drug(s):
Rifadin
Dosage: rifadin 600mg strength
Administration route: Oral
Indication: Infection
Start date: 2012-01-05
End date: 2012-01-09
Glucophage
Dosage: glucophage strength:500mg interrupted and then reintroduced
Administration route: Oral
Indication: Type 2 Diabetes Mellitus
Start date: 1995-01-01
Minocin
Dosage: minocin 100mg strngth
Administration route: Oral
Indication: Infection
Start date: 2012-01-05
End date: 2012-01-09
Possible Minocin side effects / adverse reactions in 76 year old female
Reported by a consumer/non-health professional from Germany on 2012-03-02
Patient: 76 year old female
Reactions: Hepatitis
Adverse event resulted in: hospitalization
Suspect drug(s):
Minocin
Dosage: minocin 100mg strngth
Administration route: Oral
Indication: Infection
Start date: 2012-01-05
End date: 2012-01-09
Rifadin
Dosage: rifadin 600mg strength
Administration route: Oral
Indication: Infection
Start date: 2012-01-05
End date: 2012-01-09
Glucophage
Dosage: glucophage strength:500mg interrupted and then reintroduced
Administration route: Oral
Indication: Type 2 Diabetes Mellitus
Start date: 1995-01-01
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