Ximino

Ximino Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Ximino (minocycline hydrochloride) Extended-Release Capsules is a tetracycline-class drug indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. The most commonly observed side effects are headache, fatigue, dizziness, and pruritus (itching).

Ximino is available in five dosing strengths of 45 mg, 67.5 mg, 90 mg, 112.5 mg, and 135 mg. The recommended dosage of Ximino is approximately 1 mg/kg once daily for 12 weeks. Other drugs may interact with Ximino. Tell your doctor all medications you use. Ximino can cause fetal harm when administered to a pregnant woman. The use of Ximino during tooth development (last half of pregnancy, infancy, and childhood up to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown). Ximino passes into breast milk and may harm breastfeeding babies. Breastfeeding while taking Ximino is not recommended.

Our Ximino Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Ximino FDA Prescribing Information: Side Effects
(Adverse Reactions)

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 entire FDA prescribing information for Ximino (Minocycline Hydrochloride) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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