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  • Generic Name: topronin delayed-release tablets
  • Brand Name: Thiola EC
  • Drug Class: Nephrolithiasis
Last updated on MDtodate: 10/12/2022


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

  • Proteinuria
  • Hypersensitivity

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed in the clinical trials of the drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Adverse reactions occurring at an incidence of ≥5% in an uncontrolled trial in 66 patients with cystinuria age 9 to 68 years are shown in the table below. Patients in group 1 had previously been treated with d-penicillamine; those in group 2 had not. Of those patients who had stopped taking d-penicillamine due to toxicity (34 out of 49 patients in group 1), 22 were able to continue treatment with THIOLA. In those without prior history of d-penicillamine treatment, 6% developed reactions of sufficient severity to require THIOLA withdrawal.

Table 1 presents adverse reactions ≥5% in either treatment group occurring in this trial.

Table 1: Adverse Reactions Occurring in One or More Patients

System Organ Class Adverse Reaction Group 1 Previously treated with d-penicillamine
(N = 49)
Group 2 Naive to d-penicillamine
(N = 17)
Blood and Lymphatic System Disorders anemia 1 (2%) 1 (6%)
Gastrointestinal Disorders nausea 12 (25%) 2 (12%)
emesis 5 (10%)
diarrhea/soft 9 (18%) 1 (6%)
stools abdominal pain _ 1 (6%)
oral ulcers 6 (12%) 3 (18%)
General Disorders and Administration Site Conditions fever 4 (8%)
weakness 2 (4%) 2 (12%)
fatigue 7 (14%)
peripheral 3 (6%) 1 (6%)
(edema) chest pain _ 1 (6%)
Metabolism and Nutrition Disorders anorexia 4 (8%)
Musculoskeletal and Connective Tissue Disorders arthralgia 2 (12%)
Renal and Urinary Disorders proteinuria 5 (10%) 1 (6%)
impotence 1 (6%)
Respiratory, Thoracic and Mediastinal Disorders cough 1 (6%)
Skin and Subcutaneous Tissue Disorders rash 7 (14%) 2 (12%)
ecchymosis 3 (6%)
pruritus 2 (4%) 1 (6%)
urticaria 4 (8%)
skin wrinkling 3 (6%) 1 (6%)


Taste Disturbance

A reduction in taste perception may develop. It is believed to be the result of chelation of trace metals by tiopronin. Hypogeusia is often self-limited.

Postmarketing Experience

Adverse reactions have been reported from the literature, as well as during post-approval use of THIOLA. Because the post-approval reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to THIOLA exposure.

Adverse reactions reported during the postmarketing use of THIOLA are listed by body system in Table 2.

Table 2: Adverse Reactions Reported for THIOLA Pharmacovigilance by System Organ Class and Preferred Term

System Organ Class Preferred Term
Cardiac Disorders congestive heart failure
Ear and Labyrinth Disorder vertigo
Gastrointestinal Disorders abdominal discomfort; abdominal distension; abdominal pain; chapped lips; diarrhea; dry mouth; dyspepsia; eructation; flatulence; gastrointestinal disorder; gastroesophageal reflux disease; nausea; vomiting; jaundice; liver transaminitis
General Disorders and Administration asthenia; chest pain; fatigue; malaise; pain; peripheral swelling; pyrexia; swelling
Site Conditions Investigations glomerular filtration rate decreased; weight increased
Metabolism and Nutrition Disorders decreased appetite; dehydration; hypophagia
Musculoskeletal and Connective Tissue Disorders arthralgia; back pain; flank pain; joint swelling; limb discomfort; musculoskeletal discomfort; myalgia; neck pain; pain in extremity
Nervous System Disorders ageusia; burning sensation; dizziness; dysgeusia; headache; hypoesthesia
Renal and Urinary Disorders nephrotic syndrome; proteinuria; renal failure
Skin and Subcutaneous Tissue Disorders dry skin; hyperhidrosis; pemphigus foliaceus; pruritus; rash; rash pruritic; skin irritation; skin texture abnormal; skin wrinkling; urticaria



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