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Tolinase Side Effects

Generic Name: tolazamide

Note: This page contains side effects data for the generic drug tolazamide. It is possible that some of the dosage forms included below may not apply to the brand name Tolinase.

For the Consumer

Applies to tolazamide: oral tablet

As well as its needed effects, tolazamide (the active ingredient contained in Tolinase) may cause unwanted side effects that require medical attention.

Major Side Effects

If any of the following side effects occur while taking tolazamide, check with your doctor immediately:

Rare
  • Abdominal or stomach pain
  • chills
  • clay-colored stools
  • dark urine
  • diarrhea
  • difficulty swallowing
  • dizziness
  • fast heartbeat
  • fever
  • headache
  • hives
  • itching
  • loss of appetite
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • rash
  • shortness of breath
  • skin rash
  • tightness in chest
  • unpleasant breath odor
  • unusual tiredness or weakness
  • vomiting of blood
  • wheezing
  • yellow eyes or skin
Incidence not known:
  • Agitation
  • back, leg, or stomach pains
  • black, tarry stools
  • bleeding gums
  • blood in urine or stools
  • chest pain
  • coma
  • confusion
  • convulsions
  • cough or hoarseness
  • decreased urine output
  • depression
  • difficulty breathing
  • fast or irregular heartbeat
  • fatigue
  • fever with or without chills
  • fluid-filled skin blisters
  • general body swelling
  • general feeling of tiredness or weakness
  • hostility
  • increased thirst
  • irritability
  • itching of the skin
  • lethargy
  • light-colored stools
  • lower back or side pain
  • muscle pain or cramps
  • muscle twitching
  • nausea or vomiting
  • nosebleeds
  • painful or difficult urination
  • pale skin
  • pinpoint red spots on skin
  • rapid weight gain
  • seizures
  • sensitivity to the sun
  • skin thinness
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • stupor
  • swelling of the face, ankles, or hands
  • swollen or painful glands
  • unusual bleeding or bruising

If any of the following symptoms of overdose occur while taking tolazamide, get emergency help immediately:

Symptoms of overdose:
  • Anxiety
  • cold sweats
  • cool, pale skin
  • increased hunger
  • nervousness
  • nightmares
  • shakiness
  • slurred speech

Minor Side Effects

Some tolazamide side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

Less common:
  • Indigestion
  • passing of gas
Rare
  • Feeling of constant movement of self or surroundings
  • sensation of spinning
Incidence not known:
  • Redness or other discoloration of skin
  • severe sunburn

For Healthcare Professionals

Applies to tolazamide: oral tablet

General

The most commonly reported adverse reactions have included gastrointestinal disturbances such as nausea, epigastric fullness, and heartburn.[Ref]

Metabolic

Very rare (less than 0.01%): Disulfiram-like reactions
Frequency not reported: Hypoglycemia

Sulfonylureas:
Frequency not reported: Hepatic porphyria[Ref]

Gastrointestinal

Gastrointestinal disturbances such as nausea, epigastric fullness, and heartburn tend to be dose related and may disappear when dosage is reduced.[Ref]

Common (1% to 10%): Nausea, epigastric fullness, heartburn[Ref]

Cardiovascular

In the University Group Diabetes Program (UGDP) study, cardiovascular mortality rate was approximately 2.5 times higher in patients treated for 5 to 8 years with diet plus tolbutamide 1.5 g per day compared with that of patients treated with diet alone. The UGDP study was a long-term prospective clinical trial designed to evaluate the effectiveness of glucose lowering drugs in preventing or delaying vascular complications in patients with type 2 diabetes mellitus (n=823). Tolbutamide was stopped based on the increase in cardiovascular mortality; a significant increase in total mortality was not observed, but stopping the drug may have limited the ability to measure that. In view of the close similarities in mode of action and chemical structure among sulfonylureas, these results may apply to other drug in this class.[Ref]

Sulfonylureas:
Frequency not reported: Increased cardiovascular mortality[Ref]

Hypersensitivity

Frequency not reported: Hypersensitivity reactions[Ref]

Hypersensitivity reactions described as skin reactions, e.g. pruritus, erythema, urticaria, and morbilliform or maculopapular eruptions occurred in 0.4% of patients during clinical trials. These may be transient and may disappear despite continued therapy; however, if skin reactions persist, this drug should be discontinued.[Ref]

Nervous system

Uncommon (0.1% to 1%): Dizziness, headache, weakness[Ref]

Hepatic

Rare (less than 0.1%): Cholestatic jaundice[Ref]

Endocrine

Frequency not reported: Hyponatremia

Sulfonylureas:
Frequency not reported: Syndrome of inappropriate antidiuretic hormone (SIADH) secretion[Ref]

Other

Uncommon (0.1% to 1%): Fatigue, malaise, vertigo[Ref]

Hematologic

Sulfonylureas:
Rare (less than 0.1%): Leukopenia, agranulocytosis, thrombocytopenia, hemolytic anemia, aplastic anemia, pancytopenia

Dermatologic

Uncommon (0.1% to 1%): Allergic skin reactions (pruritus, erythema, urticaria, and morbilliform or maculopapular eruptions)

Sulfonylureas:
Frequency not reported: Photosensitivity, porphyria cutanea tarda[Ref]

References

1. "Product Information. Tolazamide (TOLAZamide)." Mylan Pharmaceuticals Inc, Morgantown, WV.

It is possible that some side effects of Tolinase may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

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