Study: NCT01067339

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Notes: Reported to ER due to chest pain not relieved with sub-lingual nitroglycerin.
Frequency: 1 affected / 31 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 31 at risk

Adverse event: Fluid retention
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 31 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 31 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 31 at risk

Adverse event: Skin abcess
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Skin abcess on abdomen
Frequency: 1 affected / 31 at risk

Adverse event: Oral candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 31 at risk

Adverse event: Lower extremity edema
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 31 at risk

Adverse event: Chest discomfort/angina
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 31 at risk

Adverse event: Myocardial bridging
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 31 at risk

Adverse event: Anomalous pulmonary vein and tricuspid valve repair
Serious: no
Organ System: Cardiac disorders
Notes: Hospitalization for repair of anomalous pulmonary vein and tricuspid valve repair. Both diagnosis known prior to study start. Surgery planned for after study but changed due to increasing severity of chest pain. No significant complications.
Frequency: 1 affected / 31 at risk

Adverse event: Kidney infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 31 at risk

Adverse event: Hematoma in groin
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 34 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 34 at risk

Adverse event: Cough, chest congestion, viral
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 34 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 34 at risk

Adverse event: Overdose
Serious: no
Organ System: Surgical and medical procedures
Notes: Overdose on sedative hypnotic Hospitalized for 5 days. This even occured prior to subject starting study medication/placebo.
Frequency: 1 affected / 34 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 34 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 34 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 34 at risk

Adverse event: Cystitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 34 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: scalp laceration requiring 3 staples secondary to a fall while working in barn
Frequency: 1 affected / 34 at risk

Adverse event: Fracture right wrist
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 34 at risk

Adverse event: Irregular heart rate
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 34 at risk

Adverse event: Sweating around torso about 2 hours after taking study medication
Serious: no
Organ System: General disorders
Frequency: 1 affected / 34 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Product Issues
Notes: Allergic reaction, facial swelling and rash. Suspect Norvasc. Subject stopped Norvasc.
Frequency: 1 affected / 34 at risk

Adverse event: Hypotension
Serious: no
Organ System: Product Issues
Notes: Hypotension: Subject notes episodes of hypotension to 75/40. She relates a lower blood pressure to ingestion of L-Arginine.
Frequency: 1 affected / 34 at risk

Adverse event: Diverticulitis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Diverticulitis with cramping and frequent diarrhea.
Frequency: 1 affected / 34 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Product Issues
Notes: Diarrhea lasting 2 days. Patient states this started after she took Mucinex. It resolved when she stopped the medication.
Frequency: 1 affected / 34 at risk

Adverse event: Exostosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Bone spur right ankle noted after developing pain in the area. Surgical removal of the bone spur following completion of the study.
Frequency: 1 affected / 34 at risk

Adverse event: Chest discomfort/angina
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 34 at risk

Adverse event: Vulvovaginal mycotic infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 34 at risk

Adverse event: Abdominal cramping and diarrhea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Abdominal cramping and diarrhea. Held L-Arginine for several days. Noted partial resolution.
Frequency: 1 affected / 34 at risk

Adverse event: Muscle aches
Serious: no
Organ System: Product Issues
Notes: Noting muscle aching in the long muscles of the legs at night. Taking Crestor 40 mg daily. Reduced Crestor dose.
Frequency: 1 affected / 34 at risk

Adverse event: Inpatient psychiatric admission for pre-existing biolar disorder.
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 34 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Notes: Chest pain. Ruled out cardiac cause.
Frequency: 2 affected / 34 at risk

Adverse event: Fibromyalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Fibromyalgia with significant muscle spasm.
Frequency: 1 affected / 34 at risk

Adverse event: Difficulty swallowing medications
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 34 at risk

Adverse event: Back pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: back pain related to fall on ice.
Frequency: 1 affected / 34 at risk