THIOLA SIDE EFFECTS
- Generic Name: topronin delayed-release tablets
- Brand Name: Thiola EC
- Drug Class: Nephrolithiasis
The following adverse reactions are discussed in greater detail in other sections of the labeling:
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%)|
|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%)|
|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%)|
|Respiratory, Thoracic and Mediastinal Disorders||cough||–||1 (6%)|
|Skin and Subcutaneous Tissue Disorders||rash||7 (14%)||2 (12%)|
|pruritus||2 (4%)||1 (6%)|
|skin wrinkling||3 (6%)||1 (6%)|
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.
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|
SRC: NLM .