em Disorders
Bilirubinemia 59 (10) 51 (9) 11 (19)
Metabolic and Nutritional Disorders
Hypokalemia 181 (30) 142 (26) 30 (52)
Hypomagnesemia 110 (18) 84 (16) 11 (19)
Hyperglycemia 68 (11) 76 (14) 2 (3)
Hypocalcemia 56 (9) 55 (10) 5 (9)
Musculoskeletal System Disorders
Musculoskeletal Pain 95 (16) 82 (15) 9 (16)
Arthralgia 69 (11) 67 (12) 5 (9)
Back Pain 63 (10) 66 (12) 4 (7)
Platelet, Bleeding and Clotting Disorders
Thrombocytopenia 175 (29) 146 (27) 20 (34)
Petechiae 64 (11) 54 (10) 9 (16)
Psychiatric Disorders
Insomnia 103 (17) 92 (17) 11 (19)
Respiratory System Disorders
Coughing 146 (24) 130 (24) 14 (24)
Dyspnea 121 (20) 116 (22) 15 (26)
Epistaxis 82 (14) 73 (14) 12 (21)
Skin and Subcutaneous Tissue Disorders
Rash 113 (19) 96 (18) 25 (43)
Pruritus 69 (11) 62 (12) 11 (19)
HIV Infected Subjects with OPC: In 2 randomized comparative studies in OPC, the safety of posaconazole oral suspension at a dose of less than or equal to 400 mg QD in 557 HIV-infected patients was compared to the safety of fluconazole in 262 HIV-infected patients at a dose of 100 mg QD.
An additional 239 HIV-infected patients with refractory OPC received posaconazole oral suspension in 2 non-comparative trials for refractory OPC (rOPC). Of these subjects, 149 received the 800-mg/day dose and the remainder received the less than or equal to 400-mg QD dose.
In the OPC/rOPC studies, the most common adverse reactions were fever, diarrhea, nausea, headache, vomiting, and coughing.
The most common adverse reactions that led to treatment discontinuation of posaconazole in the Controlled OPC Pool included respiratory impairment (1%) and pneumonia (1%). In the refractory OPC pool, the most common adverse reactions that led to treatment discontinuation of posaconazole were AIDS (7%) and respiratory impairment (3%).
Table 5: Treatment-Emergent Adverse Reactions with Frequency of at Least 10% in OPC Studies with Posaconazole Oral Suspension (Treated Population)
Body System
Preferred Term
Number (%) of Subjects
Controlled OPC Pool
Refractory OPC Pool
Posaconazole
Fluconazole
Posaconazole
n=557
n=262
n=239
OPC=oropharyngeal candidiasis
* Number of subjects reporting treatment-emergent adverse reactions at least once during the study, without regard to relationship to treatment. Subjects may have reported more than 1 event.
Subjects Reporting any Adverse Reaction* 356 (64) 175 (67) 221 (92)
Body as a Whole – General Disorders
Fever 34 (6) 22 (8) 82 (34)
Headache 44 (8) 23 (9) 47 (20)
Anorexia 10 (2) 4 (2) 46 (19)
Fatigue 18 (3) 12 (5) 31 (13)
Asthenia 9 (2) 5 (2) 31 (13)
Rigors 2 (<1) 4 (2) 29 (12)
Pain 4 (1) 2 (1) 27 (11)
Disorders of Blood and Lymphatic System
Neutropenia 21 (4) 8 (3) 39 (16)
Anemia 11 (2) 5 (2) 34 (14)
Gastrointestinal System Disorders
Diarrhea 58 (10) 34 (13) 70 (29)
Nausea 48 (9) 30 (11) 70 (29)
Vomiting 37 (7) 18 (7) 67 (28)
Abdominal Pain 27 (5) 17 (6) 43 (18)
Infection and Infestations
Candidiasis, Oral 3 (1) 1 (<1) 28 (12)
Herpes Simplex 16 (3) 8 (3) 26 (11)
Pneumonia 17 (3) 6 (2) 25 (10)
Metabolic and Nutritional Disorders
Weight Decrease 4 (1) 2 (1) 33 (14)
Dehydr
