Solodyn (Minocycline Hydrochloride) - Side Effects and Adverse Reactions

ADVERSE REACTIONS

Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials 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 (%)	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, 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].

REPORTS OF SUSPECTED SOLODYN SIDE EFFECTS / ADVERSE REACTIONS

Possible Solodyn side effects / adverse reactions in 60 year old male

Reported by a physician from United States on 2011-10-04

Patient: 60 year old male

Reactions: Cardiac Failure

Adverse event resulted in: hospitalization

Suspect drug(s):
Solodyn

Other drugs received by patient: Protonix; Aspirin; Toprol-XL

Possible Solodyn side effects / adverse reactions in 29 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2011-10-25

Patient: 29 year old female

Reactions: Dyspnoea, Extrasystoles

Suspect drug(s):
Solodyn

Other drugs received by patient: Ortho TRI-Cyclen

Possible Solodyn side effects / adverse reactions in 65 year old female

Reported by a consumer/non-health professional from United States on 2011-11-02

Patient: 65 year old female weighing 83.9 kg (184.6 pounds)

Reactions: Inappropriate Schedule of Drug Administration, Confusional State, Wrong Drug Administered, Hypoaesthesia, Dizziness, Drug Dispensing Error, Blood Glucose Increased, Lethargy

Suspect drug(s):
Adapalene
    Dosage: 1 pct; 5 times wk; top
    Administration route: Topical
    Indication: Acne
    Start date: 2011-07-01

Prednisone
    Dosage: 20 mg;
    End date: 2011-08-23

Solodyn
    Dosage: 115 mg; qd; po
    Administration route: Oral
    Indication: Acne
    Start date: 2011-07-01
    End date: 2011-08-30

Other drugs received by patient: Verapamil; Pump; Effexor; Novalog Insulin; Prinzide; Prinivil