XIMINO SIDE EFFECTS
- Generic Name: minocycline hydrochloride
- Brand Name: Ximino
- Drug Class: Tetracyclines
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 1: Selected Treatment-Emergent Adverse Reactions in at least 1% of Clinical Trial Subjects
|Adverse Reactions||Minocycline hydrochloride (1 mg/kg)
N = 674 (%)
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)||1 (0)|
|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)|
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.
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.
SRC: NLM .