Note: This document contains side effect information about tiopronin. Some dosage forms listed on this page may not apply to the brand name Thiola.

Applies to tiopronin: oral tablet, oral tablet delayed release.

Serious side effects of Thiola

Along with its needed effects, tiopronin (the active ingredient contained in Thiola) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking tiopronin:

More common

• Bloating or swelling of the face, arms, hands, lower legs, or feet
• cloudy urine
• hives, itching, skin rash
• pale skin
• rapid weight gain
• tingling of the hands or feet
• trouble breathing
• unusual bleeding or bruising
• unusual tiredness or weakness
• unusual weight gain or loss

Incidence not known

• Bloody urine
• blurred vision
• chest pain or tightness
• confusion
• decreased frequency or amount of urine
• dilated neck veins
• dizziness
• dry mouth
• fainting
• headache
• increase in heart rate
• increased thirst
• irregular breathing
• irregular heartbeat
• lightheadedness
• loss of appetite
• lower back or side pain
• nausea
• nervousness
• pounding in the ears
• rapid breathing
• slow or fast heartbeat
• sunken eyes
• vomiting
• wrinkled skin
• yellow skin or eyes

Other side effects of Thiola

Some side effects of tiopronin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Bruising
• cough
• decreased interest in sexual intercourse
• diarrhea
• difficulty in moving
• fever
• inability to have or keep an erection
• large, flat, blue or purplish patches in the skin
• loss in sexual ability, desire, drive, or performance
• mouth sores
• muscle pain or stiffness
• nausea
• pain in the joints
• skin wrinkling
• stomach pain

Incidence not known

• Arm, back, neck, or leg pain
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• change in or loss of taste
• chapped lips
• dry skin
• excess air or gas in the stomach or bowels
• feeling of constant movement of self or surroundings
• full feeling
• heartburn
• increased sweating
• increased weight
• lack or loss of strength
• passing gas
• sensation of spinning
• stomach discomfort

For Healthcare Professionals

Applies to tiopronin: oral delayed release tablet, oral tablet.

Hepatic

Postmarketing reports: Jaundice, liver transaminitis^[Ref]

Hypersensitivity

Frequency not reported: Drug fever, rash, fever, arthralgia, lymphadenopathy^[Ref]

Gastrointestinal

Very common (10% or more): Nausea (25%), diarrhea/soft stools (18%), emesis (10%), oral ulcers (12%)

Frequency not reported: Abdominal pain, abdominal discomfort, abdominal distension, abdominal pain, chapped lips, dry mouth, dyspepsia, eructation, flatulence, GI disorder, gastroesophageal reflux disease^[Ref]

Metabolic

Common (1% to 10%): Anorexia^[Ref]

Dermatologic

Common (1% to 10%): Rash, ecchymosis, pruritus, urticaria, skin wrinkling

Postmarketing reports: Dry skin, hyperhidrosis, pemphigus foliaceus, skin irritation, skin texture abnormal^[Ref]

Hematologic

Common (1% to 10%): Anemia^[Ref]

Renal

Postmarketing reports: Nephrotic syndrome, renal failure^[Ref]

Respiratory

Common (1% to 10%): Cough^[Ref]

Nervous system

Postmarketing reports: Vertigo, ageusia, burning sensation, dizziness, dysgeusia, headache, hypoesthesia, asthenia^[Ref]

Musculoskeletal

Very common (10% or more): Arthralgia (12%)

Postmarketing reports: Back pain, flank pain, joint swelling, limb discomfort, musculoskeletal discomfort, myalgia, neck pain, pain in extremity^[Ref]

Other

Very common (10% or more): Fatigue/malaise (14%), weakness (12%)

Common (1% to 10%): Fever, peripheral edema

Frequency not reported: Hypogeusia (probably due to chelation of trace metals by this drug)

Postmarketing reports: Pain, peripheral swelling, pyrexia^[Ref]

Genitourinary

Frequency not reported: Proteinuria (including nephrotic syndrome), membranous nephropathy, impotence

Cardiovascular

Common (1% to 10%): Chest pain

Postmarketing reports: Congestive heart failure, chest pain