Minocycline Extended Release Tablets Side Effects
Please note - some side effects for Minocycline Extended Release Tablets may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
Minocycline Extended Release Tablets Side Effects - for the Professional
Minocycline Extended Release Tablets
Clinical Trial Experience
Because clinical trials are conducted under prescribed conditions, adverse reaction rates observed in the clinical trial 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 minocycline hydrochloride extended-release tablets.
Table 2: Selected Treatment-Emergent Adverse Reactions in at least 1% of Clinical Trial Subjects
| Adverse Event |
Minocycline HCl Extended Release Tablets (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) | 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) |
Postmarketing Experience
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.
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: thyroid discoloration, abnormal thyroid function.
Oncology: papillary 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 (13.1)].
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