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INSPRA (eplerenone) Adverse Reactions

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Adverse Reactions

Clinical Trial Adverse Events

Because clinical trials are conducted under very specific conditions the adverse drug reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug. Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates.

NYHA Class II Chronic Heart Failure

EMPHASIS-HF study: NYHA Class II chronic heart failure

In the Eplerenone in Mild Patients Hospitalization and Survival Study in Heart Failure (EMPHASIS-HF), safety was evaluated in 1364 patients treated with INSPRA and followed-up for a median duration of 675 days, and 1372 placebo-treated patients, followed-up for a median of 615 days during the double-blind phase of the trial. All causality adverse events that occurred in >2% of subjects treated with INSPRA (also incidence higher than placebo) are presented in Table 1.

Table 1. Incidence of Adverse Events ≥ 2% of Subjects in the INSPRA arm and more frequent than placebo, in the EMPHASIS-HF Study.
*
Judged as an adverse event by the investigator regardless of specific serum potassium value.
A dash indicates no statistically significant difference between treatment groups (p>0.05).

Body System

Adverse Event

INSPRA
25-50 mg QD
N=1364

Placebo
N=1372

P-value†

Blood and Lymphatic System Disorders

Anemia

32

(2.3%)

28

(2.0%)

-

Cardiac Disorders

Myocardial infarction

36

(2.6%)


34

(2.5%)

-

Gastrointestinal Disorders
Constipation

32

(2.3%)


15


(1.1%)

0.0123

Infections and Infestations
Nasopharyngitis
Upper respiratory tract infection

49

39

(3.6%)

(2.9%)


48

35

(3.5%)

(2.6%)

-

-

Metabolism and Nutrition Disorders
Diabetes mellitus
Hyperkalemia*

33

118

(2.4%)

(8.7%)


28

55


(2.0%)

(4.0%)

-

< 0.0001

Musculoskeletal and Connective Tissue Disorders

Pain in extremity

30

(2.2%)

29

(2.1%)

-

Nervous System Disorders

Dizziness

Headache

Syncope

66

35

37

(4.8%)

(2.6%)

(2.7%)

65

32

31

(4.7%)

(2.3%)

(2.3%)

-

-

-

Renal and Urinary Disorders

Renal impairment

68

(5.0%)

44

(3.2%)

0.0205

Respiratory, Thoracic and Mediastinal Disorders

Cough

57

(4.2%)

48

(3.5%)

-

Skin and Subcutaneous Tissue Disorders

Pruritus

29

(2.1%)

15

(1.1%)

0.0338

Vascular Disorders

Hypotension

55

(4.0%)

42

(3.1%)

-

The overall incidence of treatment-related adverse events reported with eplerenone versus placebo was 21.3% and 17.1%, respectively. The only treatment‑related AE that occurred in ≥ 2% of subjects in either treatment group was hyperkalemia (7.0% in the eplerenone group vs 2.9% in the placebo group).

A total of 1272 subjects reported serious adverse events (SAE); 586 subjects (43.0%) in the INSPRA group and 686 subjects (50.0%) in the placebo group.

A total of 472 subjects discontinued from the study due to adverse events; 215 subjects (15.8%) in the INSPRA group and 257 subjects (18.7%) in the placebo group. A total of 32 subjects discontinued due to hyperkalemia; 19 subjects (1.4%) in the INSPRA group and 13 subjects (0.9%) in the placebo group.

A summary of the incidence of hyperkalemia and hypokalemia is provided in Table 5.

Heart Failure following Myocardial Infarction

EPHESUS study: Post-myocardial infarction heart failure

In the eplerenone post-acute myocardial infarction heart failure efficacy and survival study (EPHESUS), safety was evaluated in 3307 patients treated with INSPRA and 3301 placebo-treated patients. Patients were followed for an average of 16 months (see CLINICAL TRIALS). Vital status was confirmed for 99.7% of patients.

The most serious adverse events in EPHESUS were endpoint events (e.g., death, cardiac failure) and these were significantly more frequent in the placebo treatment group. Serious adverse events that were significantly associated with eplerenone treatment included dehydration, arterial leg thrombosis, increased creatinine, and pyelonephritis; the incidence of these was low ( ≤ 0.5%).

Headache was the most frequent adverse reaction among eplerenone subjects in single- and multiple-dose trials. Adverse events that occurred more frequently in patients treated with INSPRA than placebo were hyperkalemia (summarized in Table 7). Eplerenone-treated patients also experienced more postural hypotension (0.7% vs 0.3% on placebo). Other adverse events more frequent during eplerenone treatment were increased blood urea nitrogen (BUN), increased creatinine, hypothyroidism, gastroesophageal reflux, pancreatitis, ketosis, arterial leg thrombosis, sepsis, and varicose veins. Hypokalemia (<3.5 mmol/l) occurred less frequently in patients treated with INSPRA (8.4% vs. 13.1%).

Elevation of serum potassium led to appropriate dose adjustments of eplerenone (see Table 16, Dose adjustment). Permanent discontinuations of eplerenone treatment due to hyperkalemia were infrequent (0.7% eplerenone vs 0.3% placebo); no eplerenone patient died from hyperkalemia. Sepsis led to permanent discontinuation of study medication in 2 eplerenone patients. No patients permanently discontinued study medication due to postural hypotension.

Adverse events experienced by ≥ 2.0% of subjects treated with INSPRA (also incidence higher than placebo) are presented in Table 2.

Table 2. Incidence of Adverse Events ≥ 2% of Subjects in the eplerenone arm and more frequent than placebo, in the EPHESUS Study.
From Fisher’s exact test. A dash indicates no statistically significant difference between treatment groups (p>0.05).

Body System

Adverse Event

INSPRA
25-50 mg QD
N=3307

Placebo
N=3301

P-value†

Autonomic Nervous System Disorders

Hypotension

Syncope

119

71

(3.6%)

(2.1%)

109

58

(3.3%)

(1.8%)

-

-

Body as a Whole - General Disorders

Asthenia

Chest Pain Non-Cardiac

Fatigue

Fever

89

213

95

67

(2.7%)

(6.4%)

(2.9%)

(2.4%)


68

206

91

65

(2.1%)

(6.2%)

(2.8%)

(2.0%)

-

-

-

-

Central and Peripheral Nervous System Disorders

Dizziness

Headache

214

126

(6.5%)

(3.8%)

197

119

(6.0%)

(3.6%)

-

-

Gastrointestinal System Disorders
Constipation

Diarrhea

Dyspepsia

Nausea

Vomiting

98

115

129

139

76

(3.0%)

(3.5%)

(3.9%)

(4.2%)

(2.3%)


92

113

120

133

59


(2.8%)

(3.4%)

(3.6%)

(4.0%)

(1.8%)

-

-

-

-

-

Heart Rate and Rhythm Disorders
Tachycardia Ventricular

70

(2.1%)


63

(1.9%)

-

Metabolism and Nutritional Disorders
Hyperkalemia

113

(3.4%)


66

(2.0%)

0.0005

Myo Endo Pericardial & Valve Disorders

Angina Pectoris

Coronary Artery Disorder

459

100

(13.9%)

(3.0%)

415

91

(12.6%)

(2.8%)

-

-

Red Blood Cell Disorders

Anemia

115

(3.5%)

98

(3.0%)

-

Urinary System Disorders

Creatinine Increase

Hematuria

Renal Function Abnormal

81

70

96

(2.4%)

(2.1%)

(2.9%)

51

55

79

(1.5%)

(1.7%)

(2.4%)

0.0105

-

-

Vascular (Extracardiac) Disorders

Cerebrovascular Disorder

103

(3.1%)

101

(3.1%)

-

The incidences of sex hormone-related adverse events are shown in Table 3.

Table 3. Rates of Sex Hormone-Related Adverse Events in EPHESUS
 

Rates in Males

Rates in Females

 

Gynecomastia

Mastodynia

Abnormal Vaginal Bleeding

Inspra

0.4%

0.1%

0.4%

Placebo

0.5%

0.1%

0.4%

Hypertension:

INSPRA has been evaluated for safety in 3,299 patients as either monotherapy or co-administration therapy in the hypertension clinical trials. A total of approximately 499 patients were treated with INSPRA for over 6 months and more than 176 patients were treated for over 1 year. The most commonly reported adverse events were headache (11.2%) and upper respiratory tract infection (7.6%).

In placebo-controlled fixed-dose trials, the overall rates of adverse events were 46% with recommended doses of INSPRA and 48% % with placebo. Adverse events occurred at a similar rate regardless of age, gender, or race. Therapy was discontinued due to an adverse event in 2.5% of patients treated with INSPRA and 2.7% of patients given placebo.

The adverse events that were reported at a rate of at least 1% of patients and at a higher rate in patients treated with INSPRA versus placebo are shown in Table 4.

Table 4. Incidence of Adverse Events ≥1% of Subjects in the INSPRA pooled arms and More Frequent than Placebo in the Placebo-Controlled Fixed-Dose Monotherapy Trials

Placebo

INSPRA

25 mg/day

50 mg/day

100 mg/day

Subjects

244

97

294

239

Body as a Whole – General disorders

Edema peripheral

4 (1.6%)

3 (3.1%)

5 (1.7%)

2 (0.8%)

Fatigue

1 (0.4%)

1 (1.0%)

4 (1.4%)

2 (0.8%)

Influenza-like symptoms

3 (1.2%)

2 (2.1%)

5 (1.7%)

5 (2.1%)

Cardiovascular Disorders

Palpitation

1 (0.4%)

1 (1.0%)

3 (1.0%)

3 (1.3%)

Central and Peripheral Nervous System Disorders

Dizziness

5 (2.0%)

3 (3.1%)

8 (2.7%)

7 (2.9%)

Gastrointestinal System Disorders

Abdominal pain

2 (0.8%)

3 (3.1%)

2 (0.7%)

4 (1.7%)

Liver and Biliary system Disorders

Bilirubinemia

0

0

1 (0.3%)

5 (2.1%)

Increased GGT

2 (0.8%)

1 (1.0%)

5 (1.7%)

3 (1.3%)

SGOT increased

2 (0.8%)

1 (1.0%)

4 (1.4%)

2 (0.8%)

SGPT increased

1 (0.4%)

1 (1.0%)

7 (2.4%)

3 (1.3%)

Metabolic

Creatine Phosphokinases Increased

2 (0.8%)

0

4 (1.4%)

4 (1.7%)

Hypercholesterolemia

0

0

5 (1.7%)

3 (1.3%)

Hypertriglyceridemia

3 (1.2%)

0

4 (1.4%)

6 (2.5%)

Hyperuricemia

2 (0.8%)

0

4 (1.4%)

4 (1.7%)

Musculoskeletal System Disorders

Arthralgia

1 (0.4%)

0

4 (1.4%)

3 (1.3%)

Respiratory System Disorders

Bronchitis

3 (1.2%)

1 (1.0%)

2 (0.7%)

4 (1.7%)

Coughing

2 (0.8%)

0

3 (1.0%)

3 (1.3%)

Sinusitis

5 (2.0%)

3 (3.1%)

6 (2.0%)

8 (3.3%)

Upper respiratory Tract Infection

10 (4.1%)

5 (5.2%)

17 (5.8%)

13 (5.4%)

Urinary System Disorders

Albuminuria

2 (0.8%)

0

3 (1.0%)

3 (1.3%)

Gynecomastia and abnormal vaginal bleeding were reported with INSPRA (around 1%) but not with placebo. The rates increased with increasing duration of therapy.

Clinical Chemistry Findings

EMPHASIS-HF study: NYHA Class II chronic heart failure

A summary of the incidence of hyperkalemia and hypokalemia is provided in Table 5.

Table 5. Rates of Hyperkalemia and Hypokalemia - Treated Patients in EMPHASIS-HF Study

Serum potassium

mmol/L

INSPRA

N=1344

Placebo

N=1349

P-value

>6.0

2.7%

2.1%

0.3141

>5.5

12.9%

8.2%

<0.0001

<4.0

42.0%

51.7%

<0.0001

<3.5

9.0%

12.3%

0.0060

>5.5 at least 2 consecutive measurements

1.6%

0.9%

0.1182

The higher risk of hyperkalemia in patients with renal impairment and, low estimated glomerular filtration rate (eGFR) and history of diabetes mellitus (EMPHASIS-HF study) are shown in Table 6 and Table 7 respectively.

Table 6. Rates of Hyperkalemia (>5.5 mmol/L) in EMPHASIS-HF by Baseline Creatinine Clearance*
*
Estimated using the Cockroft-Gault formula.

Baseline Creatinine Clearance

INSPRA

Placebo

≤ 30 mL/min

21.4%

5.6%

31–50 mL/min

15.8%

11.8%

51–70 mL/min

13.8%

7.9%

>70 mL/min

10.0%

6.7%

Table 7. Rates of Hyperkalemia (> 5.5 mmol/L) in EMPHASIS-HF by baseline eGFR 30-50* and History of Diabetes
 

INSPRA

Placebo

eGFR 30-<50, No Diabetes

15.4%

7.6%

eGFR >50, Diabetes

13.6%

8.6%

eGFR 30-<50, Diabetes

21.8%

17.6%

eGFR >50, No Diabetes

10.7%

7.0%

EPHESUS study: Post-myocardial infarction heart failure

A summary of the incidence of hyperkalemia and hypokalemia is provided in Table 8.

Table 8. Rates of Hyperkalemia and Hypokalemia - Treated Patients in EPHESUS Study

Serum potassium

mmol/L

INSPRA

N=1344

Placebo

N=1349

P-value

>6.0

4.2%

2.7%

0.001

>5.5

15.6%

11.2%

<0.001

<4.0

42.6%

52.2%

<0.001

<3.5

8.4%

13.1%

<0.001

>5.5 at least 2 consecutive measurements

3.0%

1.7%

<0.001

The higher risk of hyperkalemia in patients with renal impairment and, proteinuria and history of diabetes mellitus (EPHESUS study) are shown in Table 9 and Table 10 respectively.

Table 9. Rates of Hyperkalemia ( >5.5 mmol/L) in EPHESUS by Baseline Creatinine Clearance*
*
Estimated using the Cockroft-Gault formula.

Baseline Creatinine Clearance

INSPRA

Placebo

≤ 30 mL/min

31.5%

22.6%

31–50 mL/min

24.1%

12.7%

51–70 mL/min

16.9%

13.1%

>70 mL/min

10.8%

8.7%

Table 10. Rates of Hyperkalemia ( >5.5 mmol/L) in EPHESUS by Proteinuria and History of Diabetes*
*
Diabetes assessed as positive medical history at baseline; proteinuria assessed by positive dipstick urinalysis at baseline.
 

INSPRA

Placebo

Proteinuria, No Diabetes

16.1%

10.8%

No Proteinuria, Diabetes

18.0%

12.9%

Proteinuria and Diabetes

26.0%

15.9%

No Proteinuria, No Diabetes

12.8%

10.3%

Creatinine: Increases of more than 44 umol/L were reported in 6.5% of patients administered INSPRA and in 4.9% of placebo-treated patients.

Blood Urea Nitrogen: In EPHESUS, a mean increase of 0.17 mmol/L in blood urea nitrogen (BUN) was reported in patients treated with INSPRA and a mean 0.31 mmol/L decrease for placebo-treated patients. BUN increased in 1.6% and 1.0% of subjects, respectively. The incidence of patients with a value of 1.3xULN for BUN is 36.0% for the eplerenone group compared to 30.5% for placebo.

Abnormal Hematologic and Clinical Chemistry Findings in Hypertension Trials

Potassium: In the combined controlled trials, hyperkalemia rate increased with decreasing renal function, and increased with the co-administration with other antihypertensive drugs as shown in Table 11 below. It is noted that in the trial some patients were treated with higher than the maximal recommended dose of 50 mg twice daily.

Table 11. Maximal Serum Potassium >5.5 mmol/L and >5.9 mmol/L by Baseline Creatinine Clearance in the Combined Controlled Hypertension Trials*
*
It is noted that in these trials some patients were treated with higher than maximal recommended dose of 50 mg twice daily.

Baseline Creatinine Clearance

Maximum Potassium (mmol/L)

Placebo

% (patient #)

INSPRA monotherapy

% (patient #)

Co-Administration

therapy

% (patient #)

<50 mL/min

>5.5

0 (0/6)

18.2% (6/33)

33.3 (3/9)

>5.9

0 (0/6)

6.1 % (2/33)

11.1 (1/24)

50 – 70 mL/min

>5.5

0 (0/35)

7.5 (12/160)

17.2 (15/87)

>5.9

0 (0/35)

2.5% (4/160)

4.6 (4/87)

>70 – 100 mL/min

>5.5

2.5 (3/121)

5.0 (31/624)

12.1 (33/272)

>5.9

1.7 (2/121)

1.1 (7/624)

2.6 (7/272)

>100 mL/min

>5.5

0.8 (2/252)

2.7 (27/1014)

3.9 (22/563)

>5.9

0.4 (1/252)

0.7 (7/1014)

1.2 (7/563)

Sodium: Hyponatremia (<135 mmol/L) was reported for 0% of placebo-treated patients, 0% in 25 mg daily INSPRA group, 0.7% in 50 mg daily INSPRA group and 2.1% in 100 mg daily INSPRA group.

Triglycerides: Increases in triglycerides (above 2.83 mmol/L) were reported for 6.5% in placebo group, 9.2% in 25 mg INSPRA group, 6.0% in 50 mg daily INSPRA group and 7.8% in 100 mg daily INSPRA group.

Cholesterol: Increases in serum cholesterol values greater than 5.17mmol/L were reported for 0% in placebo group, 0% in 25 mg daily INSPRA group, 1.7% in 50 mg daily INSPRA group and 1.3% in 100 mg daily INSPRA group.

Less Common Clinical Trial Adverse Events

EMPHASIS-HF study: NYHA Class II chronic heart failure

Table 12. Incidence of Adverse Events < 2%* of Subjects in the INSPRA arm and more frequent than placebo, in the EMPHASIS-HF Study
*
[common : >1% - < 2%; uncommon >0.1%<1%)]

Blood and lymphatic system disorders

Uncommon: Thrombocytopenia

Cardiac Disorders

Common: Bradycardia

Uncommon: Acute myocardial infarction, Cardiac asthma, Cardiogenic shock, Cardiovascular disorder, Congestive cardiomyopathy, Coronary artery disease, Extrasystoles, Mitral valve incompetence, Sinus tachycardia, Supraventricular tachycardia, Tachycardia, Ventricular arrhythmia, Ventricular fibrillation

Eye disorders

Uncommon: Conjunctival hemorrhage, Glaucoma, Vision blurred

Gastrointestinal disorders

Common: Dyspepsia, Gastritis,

Uncommon: Abdominal pain upper, Anal fissure, Ascites, Duodenitis, Hemorrhoids, Inguinal hernia, Toothache

General disorders and administration site conditions

Uncommon: Influenza like illness, Malaise, Pain

Immune system disorders

Uncommon: Hypersensitivity

Infections and infestations

Common: Gastroenteritis, Influenza

Uncommon: Cellulitis, Gangrene, Gastroenteritis viral, Gastrointestinal infection, Herpes zoster, Implant site infection, Localised infection, Lung infection, Pharyngitis, Pyelonephritis, Sinusitis, Tooth abscess, Tooth infection, Viral infection

Injury, poisoning and procedural complications

Common: Fall

Uncommon: Laceration, Ligament sprain, Radius fracture, Road traffic accident, Upper limb fracture

Investigations

Common: Blood creatinine increased, Blood urea increased

Uncommon: Alanine aminotransferase increase, Blood glucose increased, Blood potassium increased, Blood uric acid increased, Epidermal growth factor receptor, Glomerular filtration rate decrease, Hemoglobin decreased, Hepatic enzyme increased, International normalised ratio increase, Liver function test abnormal, Weight decreased, Weight increased

Metabolism and nutrition disorders

Common: Dehydration

Uncommon: Decreased appetite, Dyslipidemia, Hyponatremia, Hypovolemia, Iron deficiency

Musculoskeletal and connective tissue disorders

Common: Arthralgia, Muscle spasms, Osteoarthritis

Uncommon: Bursitis, Muscular weakness, Musculoskeletal chest pain, Musculoskeletal pain, Osteitis, Osteochondrosis, Osteoporosis

Neoplasms benign, malignant and unspecified

Uncommon: Bronchial carcinoma, Colon neoplasm, Lung neoplasm

Nervous system disorders

Uncommon: Carotid artery stenosis, Carpal tunnel syndrome, Dementia, Diabetic neuropathy, Dizziness postural, Dysarthria, Hypoesthesia, Neuralgia, Neuropathy peripheral, Paresthesia, Polyneuropathy

Psychiatric disorders

Uncommon: Anxiety, Depressed mood

Renal and urinary disorders

Uncommon: Nocturia, Pollakiuria, Renal failure chronic, Urinary retention

Respiratory, thoracic and mediastinal disorders

Uncommon: Acute pulmonary oedema, Hemoptysis, Lung disorder, Nasal congestion, Pneumothorax, Productive cough

Skin and subcutaneous tissue disorders

Uncommon: Dermatitis allergic, Psoriasis, Rash, Skin lesion

Surgical and medical procedures

Uncommon: Cardiac pacemaker replacement, Prophylaxis

Vascular disorders

Uncommon: Extremity necrosis, Intermittent claudication, Peripheral coldness, Phlebitis

EPHESUS study: Post-myocardial infarction heart failure

Table 13. Incidence of Adverse Events < 2%* of Subjects in the INSPRA arm and more frequent than placebo, in the EPHESUS Study
*
[common : >1% - < 2%; uncommon >0.1%<1%)]

Application Site Disorders

Uncommon: Injection site reaction

Autonomic Nervous System Disorders

Uncommon: Hypotension Postural, Pre-syncope

Body as a Whole - General Disorders

Common: Influenza-like symptoms, Vertigo

Uncommon: Chills, Cyst NOS, Edema, Edema generalized, Face edema, Hot flushes, Laboratory test abnormal, Malaise, Pain, Post-operative incision pain, Respite care, Sternal wound infection

Cardiovascular Disorders, General

Uncommon: Circulatory failure, Intra-cardiac thrombus

Central and Peripheral Nervous System Disorders

Common: Cramps legs

Uncommon: Aphasia, Ataxia, Dementia, Dysphonia, Encephalopathy, Hemiparesis, Hypotonia, Paresthesia, Tremor

Disorders, Female

Uncommon: Breast neoplasm female, Breast neoplasm malignant female, Leukorrhea, Mastitis acute female, Menstrual disorder, Uterine disorder NOS, Vaginitis, Vaginitis atrophic,

Disorders, Male

Uncommon: Benign prostatic hyperplasia, Impotence

Endocrine Disorders

Uncommon: Hyperthyroidism, Hypothyroidism

Gastro-intestinal System Disorders

Common: Gastritis

Uncommon: Abdominal distension, Appendicitis, Duodenal ulcer, Duodenitis, Dysphagia, Flatulence, Gastric ulcer, Gastroenteritis, Gastroesophageal reflux, Hematemesis, Hemorrhage rectum, Hemorrhoids, Hernia, Hiatal hernia, Pancreatitis, Peptic ulcer

Hearing and Vestibular Disorders

Uncommon: Earache, Tinnitus

Heart Rate and Rhythm Disorders

Common: Arrhythmia atrial, Fibrillation ventricular, Palpitation

Uncommon: AV block, Tachycardia, Tachycardia supraventricular

Liver and Biliary System Disorders

Uncommon: Biliary pain, Cholecystitis, Cholelithiasis, Jaundice, Liver fatty

Metabolic and Nutritional Disorders

Uncommon: Acidosis, Dehydration, Hypertriglyceridemia, Hypoproteinemia, Ketosis, Weight decrease

Musculo-Skeletal System Disorders

Common: Fracture accidental

Uncommon: Arthrosis, Osteoporosis, Tendonitis,

Myo Endo Pericardial & Valve Disorders

Common: Myocardial ischemia

Uncommon: Cardiomyopathy, Pericardial effusion,

Neoplasm

Uncommon: GI neoplasm malignant, Neoplasm, Pulmonary carcinoma

Platelet, Bleeding & Clotting Disorders

Uncommon: Ecchymosis, Prothrombin decreased, Thrombosis arterial leg

Psychiatric Disorders

Uncommon: Apathy, Neurosis, Thinking abnormal

Resistance Mechanism Disorders

Uncommon: Herpes Zoster, Infection, Infection viral, Moniliasis, Moniliasis genital, Otitis media, Sepsis

Respiratory System Disorders

Uncommon: Abnormal breath sounds, Atelectasis, Hyperventilation, Laryngitis, Pharyngitis, Respiratory arrest, Respiratory disorder, Respiratory insufficiency, Rhinitis, Sinusitis, Sputum increased

Skin and Appendages Disorders

Common: Pruritus

Uncommon: Alopecia, Angioedema, Dermatitis, Inflammation, Rash Maculo-papular, Skin dry, Sweating increased, Urticaria

Special Senses Other, Disorders

Uncommon: Taste perversion

Urinary System Disorders

Common: Albuminuria, Bun increased

Uncommon: Bladder carcinoma, Hydronephrosis, Micturition frequency, Nocturia, Polyuria, Pyelonephritis, Renal calculus, Renal cyst, Urinary incontinence, Urinary retention

Vascular (Extracardiac) Disorders

Uncommon: Cerebral hemorrhage, Claudication intermittent, Gangrene, Peripheral ischemia, Peripheral vascular disease, Phlebitis, Thrombophlebitis, Vein varicose

Vision Disorders

Uncommon: Diplopia, Retinal disorder,

White Cell and RES Disorders

Uncommon: Eosinophilia, Leukocytosis, Leukopenia, Lymphadenopathy, Lymphocytosis

Hypertension Trials: the pooled placebo-controlled, fixed-dose INSPRA hypertension studies data

Table 14. Incidence of Adverse Events < 1% of Subjects in the INSPRA arms and more frequent than placebo, in the placebo-controlled, fixed-dose Study

Application Site Disorders

Cellulitis

Autonomic Nervous System

Syncope, Glaucoma, Mouth Dry

Body as A Whole – General Disordoers

Allergy, Chills, Laboratory test abnormal, Pain

Cardiovascular Disorders

Angina pectoris, ECG abnormal, Myocardial infarction, Arrhythmia (atrial and ventricular), Fibrillation atrial

Central and Peripheral Nervous System Disorders

Cramps legs, Migraine, Neuralgia, Paresthesia, Scotoma, Vertigo

Collagen Disorders

Arthritis Rheumatoid

Female Patients Disorders

Menstrual disorder,

Male Patients Disorders

Libido decreased

Endocrine Disorders

Sialoadenitis

Gastro-Intestinal System Disorders

Diverticulitis, Esophagitis, Gastroesophageal reflux, H Pylori , Hemorrhoids, Oral pain, Stomatitis, Vomiting

Hearing and Vestibular Disorders

Labyrinthine disorder, Tinnitus

Metabolic and Nutritional Disorders

Gout, Hypercalcemia, Hyperchloremia

Musculoskeletal System Disorders

Arthritis, Myalgia

Platelet, Bleeding & Clotting Disorders

Prothrombin decreased, Thrombocytopenia

Psychiatric Disorders

Agitation, Confusion, Depression, Anxiety

Red Blood Cell Disorders

Anemia, Hyperhemoglobinemia

Resistance Mechanism Disorders

Herpes zoster, Infection bacterial, Moniliasis genital, Otitis Media, Sepsis

Respiratory System Disorders

Bronchospasm, Laryngitis, Rhinitis, Sputum Increased

Skin and appendages Disorders

Eczema, Nail disorder, Rash macolo-papular

Urinary System Disorders

BUN increased, Cystitis, Hematuria, Oligura, Renal function abnormal, Renal pain, Urine abnormal, Micturition Frequency

Vision Disorders

Blurred vision, Vision abnormal

White Cell and RES Disorders

Eosinophilia, Granulocytosis, Leukopenia, Monocytosis

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