Table 3 Burproion: comparative analysis of the label information from FDA and the results of BCPNN on blogs, AERS and MEDLINE data

Angioedema

Airway obstruction; hoarseness

Angioedema;

Angioedema

Myalgia

Fibromyalgia

Fibromyalgia; myalgia

–

Muscle rigidity; muscle weakness; musculoskeletal chest pain

Muscle cramps; myasthenia gravis

Muscle atrophy; muscle spasm; muscle strain; muscle twitching; musculoskeletal discomfort; musculoskeletal stiffness

–

Polyuria; dysuria; glucosuria

Proteinuria; hematuria

Nocturia; pollakiuria

–

Liver damage

Liver failure

–

–

Dry mouth; dry skin; dry eye;

Dehydration; dry mouth; dry eye syndrome;

Dry mouth; dry skin

Dry mouth; dry eye

Constipation; and headache

-

-

-

Chest pain

Breast neoplasms; neoplasms;

Breast cancer female; breast pain; drug exposure via breast milk; neoplasm; non-cardiac chest pain

Lung neoplasms

Neck pain

Back pain; intervetebral disc displacement; chronic pain; Neck pain

Back pain; neck pain; inter-vertebral disc injury; inter-vertebral disc protrusion

–

Dream abnormality

Bad dreams

Abnormal dreams

–

–

Constriction, pathologic

–

–

–

Contusions

–

–

–

Hypothyroidism; hashimoto disease

Hypothyroidism

–

–

Kidney diseases

–

–

Binge eating

Eating disorders; diabetes mellitus, type 2

Diabetes mellitus inadequate control; type 2 diabetes mellitus; type 1 diabetes mellitus

Binge-eating disorder, bulimia

Urinary frequency, urinary incontinence, urinary urgency, urinary retention, urine abnormality

–

Urine abnormality, metanephrine urine increased

–