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 practice.
The following table summarizes selected adverse reactions reported in clinical trials at a rate of ≥ 1% for SOLODYN.
Table 2: Selected Treatment-Emergent Adverse Reactions
in at least 1% of Clinical Trial Subjects
|Adverse Reactions||SOLODYN (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)|
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].
Central nervous system: pseudotumor cerebri, bulging fontanels in infants, decreased hearing.
Renal: reversible acute renal failure.
Read the Solodyn (minocycline hydrochloride) Side Effects Center for a complete guide to possible side effects
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 SOLODYN on low dose oral contraceptives, hormone levels over one menstrual cycle with and without SOLODYN 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.
Read the Solodyn Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 10/31/2013
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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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