Reyataz Side Effects

Please note - some side effects for Reyataz may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Reyataz - for the Consumer

Reyataz

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Reyataz:

Changes in body fat; cough; diarrhea; fatigue; headache; increased cough; muscle pain; nausea; pain; stomach pain; trouble sleeping; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur when using Reyataz:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in the urine; chest pain; dizziness; fever, chills, or sore throat; increased urination or thirst; irregular heartbeat; lightheadedness; mental or mood changes (eg, depression); numbness, tingling, or extreme weakness especially in the arms or legs; painful urination; red, blistered, or swollen skin; severe nausea or vomiting; severe stomach or side pain; trouble breathing; unusual bleeding or bruising; yellowing of skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Reyataz Side Effects - for the Professional

Reyataz

The following adverse reactions are discussed in greater detail in other sections of the labeling:

• cardiac conduction abnormalities [see Warnings and Precautions (5.2)]
• rash [see Warnings and Precautions (5.3)]
• hyperbilirubinemia [see Warnings and Precautions (5.4)]
• nephrolithiasis [see Warnings and Precautions (5.6)]

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.

Clinical Trial Experience in Adults

Treatment-Emergent Adverse Reactions in Treatment-Naive Patients

The safety profile of Reyataz in treatment-naive adults is based on 1625 HIV-1 infected patients in clinical trials. 536 patients received Reyataz 300 mg with ritonavir 100 mg and 1089 patients received Reyataz 400 mg or higher (without ritonavir).

The most common adverse reactions are nausea, jaundice/scleral icterus, and rash.

Selected clinical adverse reactions of moderate or severe intensity reported in ≥2% of treatment-naive patients receiving combination therapy including Reyataz 300 mg with ritonavir 100 mg and Reyataz 400 mg (without ritonavir) are presented in Tables 4 and 5, respectively.

Table 4: Selected Treatment-Emergent Adverse Reactionsa of Moderate or Severe Intensity Reported in ≥2% of Adult Treatment-Naive Patients,b Study AI424-138

	96 weeksc	96 weeksc
	Reyataz 300 mg with ritonavir 100 mg (once daily) and tenofovir with emtricitabined	lopinavir 400 mg with ritonavir 100 mg (twice daily) and tenofovir with emtricitabined
	(n=441)	(n=437)
* None reported in this treatment arm.
a Includes events of possible, probable, certain, or unknown relationship to treatment regimen.
b Based on the regimen containing Reyataz.
c Median time on therapy.
d As a fixed-dose combination: 300 mg tenofovir, 200 mg emtricitabine once daily.
Digestive System
Nausea	4%	8%
Jaundice/scleral icterus	5%	*
Diarrhea	2%	12%
Skin and Appendages
Rash	3%	2%

Table 5: Selected Treatment-Emergent Adverse Reactionsa of Moderate or Severe Intensity Reported in ≥2% of Adult Treatment-Naive Patients,b Studies AI424-034, AI424-007, and AI424-008

	Study AI424-034		Studies AI424-007, -008
	64 weeksc Reyataz 400 mg once daily + lamivudine + zidovudinee	64 weeksc efavirenz 600 mg once daily + lamivudine + zidovudinee	120 weeksc,d Reyataz 400 mg once daily + stavudine + lamivudine or didanosine	73 weeksc,d nelfinavir 750 mg TID or 1250 mg BID + stavudine + lamivudine or didanosine
	(n=404)	(n=401)	(n=279)	(n=191)
* None reported in this treatment arm.
a Includes events of possible, probable, certain, or unknown relationship to treatment regimen.
b Based on regimens containing Reyataz.
c Median time on therapy.
d Includes long-term follow-up.
e As a fixed-dose combination: 150 mg lamivudine, 300 mg zidovudine twice daily.
Body as a Whole
Headache	6%	6%	1%	2%
Digestive System
Nausea	14%	12%	6%	4%
Jaundice/scleral     icterus	7%	*	7%	*
Vomiting	4%	7%	3%	3%
Abdominal pain	4%	4%	4%	2%
Diarrhea	1%	2%	3%	16%
Nervous System
Insomnia	3%	3%	<1%	*
Dizziness	2%	7%	<1%	*
Peripheral neurologic    symptoms	<1%	1%	4%	3%
Skin and Appendages
Rash	7%	10%	5%	1%

Treatment-Emergent Adverse Reactions in Treatment-Experienced Patients

The safety profile of Reyataz in treatment-experienced adults is based on 119 HIV-1 infected patients in clinical trials.

The most common adverse reactions are jaundice/scleral icterus and myalgia.

Selected clinical adverse reactions of moderate or severe intensity reported in ≥2% of treatment-experienced patients receiving Reyataz/ritonavir are presented in Table 6.

Table 6: Selected Treatment-Emergent Adverse Reactionsa of Moderate or Severe Intensity Reported in ≥2% of Adult Treatment-Experienced Patients,b Study AI424-045

	48 weeksc Reyataz/ritonavir 300/100 mg once daily + tenofovir + NRTI	48 weeksc lopinavir/ritonavir 400/100 mg twice dailyd + tenofovir + NRTI
	(n=119)	(n=118)
* None reported in this treatment arm.
a Includes events of possible, probable, certain, or unknown relationship to treatment regimen.
b Based on the regimen containing Reyataz.
c Median time on therapy.
d As a fixed-dose combination.
Body as a Whole
Fever	2%	*
Digestive System
Jaundice/scleral icterus	9%	*
Diarrhea	3%	11%
Nausea	3%	2%
Nervous System
Depression	2%	<1%
Musculoskeletal System
Myalgia	4%	*

Laboratory Abnormalities in Treatment-Naive Patients

The percentages of adult treatment-naive patients treated with combination therapy including Reyataz (atazanavir sulfate) 300 mg with ritonavir 100 mg and Reyataz 400 mg (without ritonavir) with Grade 3–4 laboratory abnormalities are presented in Tables 7 and 8, respectively.

Table 7: Grade 3–4 Laboratory Abnormalities Reported in ≥2% of Adult Treatment-Naive Patients,a Study AI424-138

a Based on the regimen containing Reyataz.
b Median time on therapy.
c ULN = upper limit of normal.
d As a fixed-dose combination: 300 mg tenofovir, 200 mg emtricitabine once daily.
Variable	Limitc	96 weeksb	96 weeksb
		Reyataz 300 mg with ritonavir 100 mg (once daily) and tenofovir with emtricitabined	lopinavir 400 mg with ritonavir 100 mg (twice daily) and tenofovir with emtricitabined
		(n=441)	(n=437)
Chemistry	High
SGOT/AST	≥5.1 x ULN	3%	1%
SGPT/ALT	≥5.1 x ULN	3%	2%
Total Bilirubin	≥2.6 x ULN	44%	<1%
Lipase	≥2.1 x ULN	2%	2%
Creatine Kinase	≥5.1 x ULN	8%	7%
Total Cholesterol	≥240 mg/dL	11%	25%
Hematology	Low
Neutrophils	<750 cells/mm3	5%	2%

Table 8: Grade 3–4 Laboratory Abnormalities Reported in ≥2% of Adult Treatment-Naive Patients,a Studies AI424-034, AI424-007, and AI424-008

Variable	Limitd	Study AI424-034		Studies AI424-007, -008
		64 weeksb	64 weeksb	120 weeksb,c	73 weeksb,c
		Reyataz 400 mg once daily + lamivudine + zidovudinee	efavirenz 600 mg once daily + lamivudine + zidovudinee	Reyataz 400 mg once daily + stavudine + lamivudine or + stavudine + didanosine	nelfinavir 750 mg TID or 1250 mg BID + stavudine + lamivudine or + stavudine + didanosine
		(n=404)	(n=401)	(n=279)	(n=191)
* None reported in this treatment arm.
a Based on regimen(s) containing Reyataz.
b Median time on therapy.
c Includes long-term follow-up.
d ULN = upper limit of normal.
e As a fixed-dose combination: 150 mg lamivudine, 300 mg zidovudine twice daily.
Chemistry	High
SGOT/AST	≥5.1 x ULN	2%	2%	7%	5%
SGPT/ALT	≥5.1 x ULN	4%	3%	9%	7%
Total Bilirubin	≥2.6 x ULN	35%	<1%	47%	3%
Amylase	≥2.1 x ULN	*	*	14%	10%
Lipase	≥2.1 x ULN	<1%	1%	4%	5%
Creatine Kinase	≥5.1 x ULN	6%	6%	11%	9%
Total Cholesterol	≥240 mg/dL	6%	24%	19%	48%
Triglycerides	≥751 mg/dL	<1%	3%	4%	2%
Hematology	Low
Hemoglobin	<8.0 g/dL	5%	3%	<1%	4%
Neutrophils	<750 cells/mm3	7%	9%	3%	7%

Laboratory Abnormalities in Treatment-Experienced Patients

The percentages of adult treatment-experienced patients treated with combination therapy including Reyataz/ritonavir with Grade 3–4 laboratory abnormalities are presented in Table 9.

Table 9: Grade 3–4 Laboratory Abnormalities Reported in ≥2% of Adult Treatment-Experienced Patients, Study AI424-045a

Variable	Limitc	48 weeksb	48 weeksb
		Reyataz/ritonavir 300/100 mg once daily + tenofovir + NRTI	lopinavir/ritonavir 400/100 mg twice dailyd + tenofovir + NRTI
		(n=119)	(n=118)
a Based on regimen(s) containing Reyataz.
b Median time on therapy.
c ULN = upper limit of normal.
d As a fixed-dose combination.
Chemistry	High
SGOT/AST	≥5.1 x ULN	3%	3%
SGPT/ALT	≥5.1 x ULN	4%	3%
Total Bilirubin	≥2.6 x ULN	49%	<1%
Lipase	≥2.1 x ULN	5%	6%
Creatine Kinase	≥5.1 x ULN	8%	8%
Total Cholesterol	≥240 mg/dL	25%	26%
Triglycerides	≥751 mg/dL	8%	12%
Glucose	≥251 mg/dL	5%	<1%
Hematology	Low
Platelets	<50,000 cells/mm3	2%	3%
Neutrophils	<750 cells/mm3	7%	8%

Lipids, Change from Baseline in Treatment-Naive Patients

For Study AI424-138 and Study AI424-034, changes from baseline in LDL-cholesterol, HDL-cholesterol, total cholesterol, and triglycerides are shown in Tables 10 and 11, respectively.

Table 10: Lipid Values, Mean Change from Baseline, Study AI424-138

	Reyataz/ritonavira,b					lopinavir/ritonavirb,c
	Baseline	Week 48		Week 96		Baseline	Week 48		Week 96
	mg/dL	mg/dL	Changed	mg/dL	Changed	mg/dL	mg/dL	Changed	mg/dL	Changed
	(n=428e)	(n=372e)	(n=372e)	(n=342e)	(n=342e)	(n=424e)	(n=335e)	(n=335e)	(n=291e)	(n=291e)
	a Reyataz 300 mg with ritonavir 100 mg once daily with the fixed-dose combination: 300 mg tenofovir, 200 mg emtricitabine once daily.
b Values obtained after initiation of serum lipid-reducing agents were not included in these analyses. At baseline, serum lipid-reducing agents were used in 1% in the lopinavir/ritonavir treatment arm and 1% in the Reyataz/ritonavir arm. Through Week 48, serum lipid-reducing agents were used in 8% in the lopinavir/ritonavir treatment arm and 2% in the Reyataz/ritonavir arm. Through Week 96, serum lipid-reducing agents were used in 10% in the lopinavir/ritonavir treatment arm and 3% in the Reyataz/ritonavir arm.
c Lopinavir 400 mg with ritonavir 100 mg twice daily with the fixed-dose combination 300 mg tenofovir, 200 mg emtricitabine once daily.
d The change from baseline is the mean of within-patient changes from baseline for patients with both baseline and Week 48 or Week 96 values and is not a simple difference of the baseline and Week 48 or Week 96 mean values, respectively.
e Number of patients with LDL-cholesterol measured.
f Fasting.
LDL-Cholesterolf	92	105	+14%	105	+14%	93	111	+19%	110	+17%
HDL-Cholesterolf	37	46	+29%	44	+21%	36	48	+37%	46	+29%
Total Cholesterolf	149	169	+13%	169	+13%	150	187	+25%	186	+25%
Triglyceridesf	126	145	+15%	140	+13%	129	194	+52%	184	+50%

Table 11: Lipid Values, Mean Change from Baseline, Study AI424-034

	Reyataza,b			efavirenzb,c
	Baseline	Week 48	Week 48	Baseline	Week 48	Week 48
	mg/dL	mg/dL	Changed	mg/dL	mg/dL	Changed
	(n=383e)	(n=283e)	(n=272e)	(n=378e)	(n=264e)	(n=253e)
a Reyataz 400 mg once daily with the fixed-dose combination: 150 mg lamivudine, 300 mg zidovudine twice daily.
b Values obtained after initiation of serum lipid-reducing agents were not included in these analyses. At baseline, serum lipid-reducing agents were used in 0% in the efavirenz treatment arm and <1% in the Reyataz arm. Through Week 48, serum lipid-reducing agents were used in 3% in the efavirenz treatment arm and 1% in the Reyataz arm.
c Efavirenz 600 mg once daily with the fixed-dose combination: 150 mg lamivudine, 300 mg zidovudine twice daily.
d The change from baseline is the mean of within-patient changes from baseline for patients with both baseline and Week 48 values and is not a simple difference of the baseline and Week 48 mean values.
e Number of patients with LDL-cholesterol measured.
f Fasting.
LDL-Cholesterolf	98	98	+1%	98	114	+18%
HDL-Cholesterol	39	43	+13%	38	46	+24%
Total Cholesterol	164	168	+2%	162	195	+21%
Triglyceridesf	138	124	-9%	129	168	+23%

Lipids, Change from Baseline in Treatment-Experienced Patients

For Study AI424-045, changes from baseline in LDL-cholesterol, HDL-cholesterol, total cholesterol, and triglycerides are shown in Table 12. The observed magnitude of dyslipidemia was less with Reyataz/ritonavir than with lopinavir/ritonavir. However, the clinical impact of such findings has not been demonstrated.

Table 12: Lipid Values, Mean Change from Baseline, Study AI424-045

	Reyataz/ritonavira,b			lopinavir/ritonavirb,c
	Baseline	Week 48	Week 48	Baseline	Week 48	Week 48
	mg/dL	mg/dL	Changed	mg/dL	mg/dL	Changed
	(n=111e)	(n=75e)	(n=74e)	(n=108e)	(n=76e)	(n=73e)
a Reyataz 300 mg once daily + ritonavir + tenofovir + 1 NRTI.
b Values obtained after initiation of serum lipid-reducing agents were not included in these analyses. At baseline, serum lipid-reducing agents were used in 4% in the lopinavir/ritonavir treatment arm and 4% in the Reyataz/ritonavir arm. Through Week 48, serum lipid-reducing agents were used in 19% in the lopinavir/ritonavir treatment arm and 8% in the Reyataz/ritonavir arm.
c Lopinavir/ritonavir (400/100 mg) BID + tenofovir + 1 NRTI.
d The change from baseline is the mean of within-patient changes from baseline for patients with both baseline and Week 48 values and is not a simple difference of the baseline and Week 48 mean values.
e Number of patients with LDL-cholesterol measured.
f Fasting.
LDL-Cholesterolf	108	98	-10%	104	103	+1%
HDL-Cholesterol	40	39	-7%	39	41	+2%
Total Cholesterol	188	170	-8%	181	187	+6%
Triglyceridesf	215	161	-4%	196	224	+30%

Clinical Trial Experience in Pediatric Patients

The safety and tolerability of Reyataz Capsules with and without ritonavir have been established in pediatric patients at least 6 years of age from the open-label, multicenter clinical trial PACTG 1020A. Use of Reyataz in pediatric patients less than 6 years of age is under investigation.

The safety profile of Reyataz in pediatric patients (6 to less than 18 years of age) was generally similar to that observed in clinical studies of Reyataz in adults. The most common Grade 2–4 adverse events (≥5%, regardless of causality) reported in pediatric patients were cough (21%), fever (18%), jaundice/scleral icterus (15%), rash (14%), vomiting (12%), diarrhea (9%), headache (8%), peripheral edema (7%), extremity pain (6%), nasal congestion (6%), oropharyngeal pain (6%), wheezing (6%), and rhinorrhea (6%). Asymptomatic second-degree atrioventricular block was reported in <2% of patients. The most common Grade 3–4 laboratory abnormalities occurring in pediatric patients were elevation of total bilirubin (≥3.2 mg/dL, 58%), neutropenia (9%), and hypoglycemia (4%). All other Grade 3–4 laboratory abnormalities occurred with a frequency of less than 3%.

Patients Co-infected With Hepatitis B and/or Hepatitis C Virus

Liver function tests should be monitored in patients with a history of hepatitis B or C.

In study AI424-138, 60 patients treated with Reyataz/ritonavir 300 mg/100 mg once daily, and 51 patients treated with lopinavir/ritonavir 400 mg/100 mg twice daily, each with fixed dose tenofovir-emtricitabine, were seropositive for hepatitis B and/or C at study entry. ALT levels >5 times ULN developed in 10% (6/60) of the Reyataz/ritonavir-treated patients and 8% (4/50) of the lopinavir/ritonavir-treated patients. AST levels >5 times ULN developed in 10% (6/60) of the Reyataz/ritonavir-treated patients and none (0/50) of the lopinavir/ritonavir-treated patients.

In study AI424-045, 20 patients treated with Reyataz/ritonavir 300 mg/100 mg once daily, and 18 patients treated with lopinavir/ritonavir 400 mg/100 mg twice daily, were seropositive for hepatitis B and/or C at study entry. ALT levels >5 times ULN developed in 25% (5/20) of the Reyataz/ritonavir-treated patients and 6% (1/18) of the lopinavir/ritonavir-treated patients. AST levels >5 times ULN developed in 10% (2/20) of the Reyataz/ritonavir-treated patients and 6% (1/18) of the lopinavir/ritonavir-treated patients.

In studies AI424-008 and AI424-034, 74 patients treated with 400 mg of Reyataz (atazanavir sulfate) once daily, 58 who received efavirenz, and 12 who received nelfinavir were seropositive for hepatitis B and/or C at study entry. ALT levels >5 times the upper limit of normal (ULN) developed in 15% of the Reyataz-treated patients, 14% of the efavirenz-treated patients, and 17% of the nelfinavir-treated patients. AST levels >5 times ULN developed in 9% of the Reyataz-treated patients, 5% of the efavirenz-treated patients, and 17% of the nelfinavir-treated patients. Within atazanavir and control regimens, no difference in frequency of bilirubin elevations was noted between seropositive and seronegative patients. [See Warnings and Precautions (5.5).]

Postmarketing Experience

The following events have been identified during postmarketing use of Reyataz. Because these reactions are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Body as a Whole: edema

Cardiovascular System: second-degree AV block, third-degree AV block, left bundle branch block, QTc prolongation [see Warnings and Precautions (5.2)]

Gastrointestinal System: pancreatitis

Hepatic System: hepatic function abnormalities

Hepatobiliary Disorders: cholelithiasis, cholecystitis, cholestasis

Metabolic System and Nutrition Disorders: diabetes mellitus, hyperglycemia [see Warnings and Precautions (5.7)]

Musculoskeletal System: arthralgia

Renal System: nephrolithiasis [see Warnings and Precautions (5.6)]

Skin and Appendages: alopecia, maculopapular rash [see Contraindications (4) and Warnings and Precautions (5.3)], pruritus

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Side Effects by Body System - for Healthcare Professionals

General

The most common side effects reported in therapy-naive patients during clinical trials include nausea, jaundice/scleral icterus, and rash. The most common side effects reported in therapy-experienced patients during clinical trials include jaundice/scleral icterus and myalgia.

Hepatic

Hepatic side effects have included elevated total bilirubin (greater than or equal to 2.6 times ULN; up to 49%), ALT (greater than or equal to 5.1 times ULN; up to 25%), amylase (greater than or equal to 2.1 times ULN; up to 14%), AST (greater than or equal to 5.1 times ULN; up to 10%), and lipase (greater than or equal to 2.1 times ULN; up to 5%); and jaundice/scleral icterus (moderate or severe intensity: up to 9%). Hepatitis, hepatomegaly, liver damage, and acute hepatic cytolysis have been reported. Monitoring of liver function is recommended in patients with a history of hepatitis B or C. Hepatic function abnormalities, cholelithiasis, cholecystitis, and cholestasis have been reported during postmarketing experience.

Metabolic

Metabolic side effects have included elevated total cholesterol (greater than or equal to 240 mg/dL; up to 25%), creatine kinase (greater than or equal to 5.1 times ULN; up to 11%), triglycerides (greater than or equal to 751 mg/dL; up to 8%), glucose (greater than or equal to 251 mg/dL; 5%), LDL cholesterol, and HDL cholesterol. Ketoacidosis (rare), hyperkalemia, lactic acidosis, and symptomatic hyperlactatemia have also been reported. Hyperglycemia has been reported during postmarketing experience.

Gastrointestinal

Gastrointestinal side effects have included nausea (moderate or severe intensity: up to 14%), vomiting (moderate or severe intensity: up to 4%), abdominal pain (moderate or severe intensity: 4%), diarrhea (moderate or severe intensity: up to 3%). Treatment emergent side effects of at least moderate intensity have included acholia, anorexia, aphthous stomatitis, colitis, constipation, dental pain, dyspepsia, esophageal ulcer, gastritis, gastrointestinal disorder, pancreatitis, and peptic ulcer in less than 3% of patients during Phase II/III clinical trials. Pancreatitis has been reported during postmarketing experience.

Dermatologic

Dermatologic side effects have included rash (moderate or severe intensity: up to 7%), Stevens-Johnson syndrome, erythema multiforme, toxic skin eruptions, and photosensitivity. Pruritus, alopecia, and maculopapular rash have been reported during postmarketing experience.

Hematologic

Hematologic side effects have included decreases in neutrophils (less than 750 cells/mm3; up to 7%), hemoglobin (less than 8 g/dL; up to 5%), and platelets (less than 50,000 cells/mm3; 2%). Spontaneous bleeding in hemophiliacs has been reported rarely.

Cardiovascular

A 59-year-old HIV-infected woman with congestive heart failure and an ejection fraction of 30% started lamivudine, zidovudine, and atazanavir. One month later, the patient presented with syncope and complained of nausea, which had begun 5 days prior. During the month following treatment initiation, the patient experienced slowly progressive shortness of breath. An electrocardiogram (EKG) showed a QTc interval prolongation of 619 min. Prior to starting antiretroviral treatment, an EKG showed a QTc interval of 398 min for the patient. The patient developed continuous ventricular tachycardia and was defibrillated to sinus bradycardia, which worsened her QT interval prolongation. The patient developed torsades de pointes, which reverted following further defibrillation. Treatment to increase her heart rate and decrease her QT interval was started. The patient's antiretroviral treatment was discontinued during her hospitalization and was not restarted due to concerns regarding QT prolongation. The patient's QTc interval decreased to 394 min and she had no additional ventricular tachyarrhythmias. The patient was restarted on lamivudine, zidovudine, and atazanavir and within 2 days, EKG showed QTc interval prolongation to 571 min. The atazanavir was concluded to be the cause of the prolonged QT interval and torsades de pointes. The patient's QT interval returned to normal following discontinuation of her antiretroviral treatment.

Cardiovascular side effects of at least moderate intensity have included heart arrest, heart block, hypertension, myocarditis, palpitation, syncope, and vasodilatation in less than 3% of patients during Phase II/III clinical trials. Prolongation of the PR interval prolonged QT interval, ventricular tachycardia, torsades de pointes, and increased QRS interval have also been reported. Second degree AV block, third degree AV block, left bundle branch block, and QTc prolongation have been reported during postmarketing experience.

Nervous system

Nervous system side effects have included headache (moderate or severe intensity: up to 6%), peripheral neurological symptoms (moderate or severe intensity: up to 4%), insomnia (moderate or severe intensity: up to 3%), dizziness (moderate or severe intensity: up to 2%), and paresthesias.

Musculoskeletal

Musculoskeletal side effects have included myalgia (moderate or severe intensity: 4%). Treatment emergent side effects of at least moderate intensity have included bone pain, extremity pain, muscle atrophy, myasthenia, and myopathy in less than 3% of patients during Phase II/III clinical trials. Arthralgia has been reported during postmarketing experience.

Other

Other side effects have included fever (moderate or severe intensity: 2%). Treatment emergent side effects of at least moderate intensity have included angioedema, asthenia, burning sensation, chest pain, dysplasia, edema, facial atrophy, fatigue, generalized edema, heat sensitivity, infection, malaise, overdose, pallor, peripheral edema, substernal chest pain, and sweating in less than 3% of patients during Phase II/III clinical trials. Edema has been reported during postmarketing experience.

Psychiatric

Psychiatric side effects have included depression (moderate or severe intensity: 2%).

Renal

Renal side effects have rarely included acute interstitial nephritis, renal colic, reversible acute renal failure, and urolithiasis. Nephrolithiasis, hydronephrosis, and renal insufficiency have been reported during postmarketing experience.

An analysis of a ureteral stone determined it was 60% atazanavir metabolite and 40% calcium phosphate (carbonate apatite). The stone was not metabolites adsorbed into the apatite but contained atazanavir crystals. Analysis of renal calculi from additional patients determined concentrations of atazanavir ranging from 40% to 100%.

Hypersensitivity

Hypersensitivity side effects of at least moderate intensity have included allergic reaction in less than 3% of patients during Phase II/III clinical trials.

Immunologic

Immunologic side effects have included immune reconstitution syndrome. Patients may develop inflammatory reactions to underlying or indolent opportunistic infections.

Other

Redistribution and accumulation of body fat including central obesity, dorsocervical fat enlargement, peripheral wasting, facial wasting, breast enlargement, and cushingoid appearance have been observed in patients receiving antiretroviral therapy.

Endocrine

Endocrine side effects of at least moderate intensity have included decreased male fertility in less than 3% of patients during Phase II/III clinical trials. New onset diabetes mellitus and exacerbation of preexisting diabetes mellitus have been reported during postmarketing experience.

Respiratory

Respiratory side effects have included increased cough.

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