Ximino

Side Effects
Interactions

SIDE EFFECTS

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

The following table summarizes selected adverse reactions reported in clinical trials at a rate of ≥ 1% for minocycline hydrochloride.

Table 2: Selected Treatment-Emergent Adverse Reactions in at least 1% of Clinical Trial Subjects

Adverse Reactions Minocycline hydrochloride
(1 mg/kg)
N = 674 (%)
PLACEBO
N = 364 (%)
At least one treatment-emergent event 379 (56) 197 (54)
Headache 152 (23) 83 (23)
Fatigue 62(9) 24(7)
Dizziness 59(9) 17(5)
Pruritus 31(5) 16(4)
Malaise 26(4) 9(3)
Mood alteration 17(3) 9(3)
Somnolence 13(2) 3(1)
Urticaria 10(2) KO)
Tinnitus 10(2) 5(1)
Arthralgia 9(1) 2(0)
Vertigo 8(1) 3(1)
Dry mouth 7(1) 5(1)
Myalgia 7(1) 4(1)

Postmarketing Experience

The following adverse reactions have been identified during post approval use of minocycline hydrochloride. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Adverse reactions that have been reported with minocycline hydrochloride use in a variety of indications include:

Skin and hypersensitivity reactions: fixed drug eruptions, balanitis, erythema multiforme, Stevens-Johnson syndrome, anaphylactoid purpura, photosensitivity, pigmentation of skin and mucous membranes, hypersensitivity reactions, angioneurotic edema, anaphylaxis, DRESS syndrome [see WARNINGS AND PRECAUTIONS].

Autoimmune conditions: polyarthralgia, pericarditis, exacerbation of systemic lupus, pulmonary infiltrates with eosinophilia, transient lupus-like syndrome.

Central nervous system: pseudotumor cerebri, bulging fontanels in infants, decreased hearing.

Endocrine: brown-black microscopic thyroid discoloration, abnormal thyroid function.

Oncology: thyroid cancer.

Oral: glossitis, dysphagia, tooth discoloration.

Gastrointestinal: enterocolitis, pancreatitis, hepatitis, liver failure.

Renal: reversible acute renal failure.

Hematology: hemolytic anemia, thrombocytopenia, eosinophilia.

Preliminary studies suggest that use of minocycline may have deleterious effects on human spermatogenesis [see Nonclinical Toxicology].

Read the Ximino (minocycline hydrochloride) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

Anticoagulants

Because tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage.

Penicillin

Since bacteriostatic drugs may interfere with the bactericidal action of penicillin, it is advisable to avoid giving tetracycline-class drugs in conjunction with penicillin.

Methoxyflurane

The concurrent use of tetracycline and methoxyflurane has been reported to result in fatal renal toxicity.

Antacids and Iron Preparations

Absorption of tetracyclines is impaired by antacids containing aluminum, calcium or magnesium and iron-containing preparations.

Low Dose Oral Contraceptives

In a multi-center study to evaluate the effect of minocycline hydrochloride (administered as another extended-release formulation which is bioequivalent to Ximino) on low dose oral contraceptives, hormone levels over one menstrual cycle with and without minocycline hydrochloride 1 mg/kg once-daily were measured. Based on the results of this trial, minocycline-related changes in estradiol, progestinic hormone, FSH and LH plasma levels, of breakthrough bleeding, or of contraceptive failure, cannot be ruled out. To avoid contraceptive failure, female patients are advised to use a second form of contraceptive during treatment with minocycline.

Drug/Laboratory Test Interactions

False elevations of urinary catecholamine levels may occur due to interference with the fluorescence test.

Last reviewed on RxList: 7/30/2012
This monograph has been modified to include the generic and brand name in many instances.

Side Effects
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