Sansert Side Effects

Please note - some side effects for Sansert may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Sansert Side Effects - for the Professional

Sansert

Within the recommended dose levels, the following side effects have been reported:

1)      Fibrotic Complications

Fibrotic changes have been observed in the retroperitoneal, pleuropulmonary, cardiac, and other tissues, either singly or, very rarely, in combination.

This nonspecific fibrotic process is usually confined to the retroperitoneal connective tissue above the pelvic brim and may present clinically with one or more symptoms such as general malaise, fatigue, weight loss, backache, low grade fever (elevated sedimentation rate), urinary obstruction (girdle or flank pain, dysuria, polyuria, oliguria, elevated BUN), vascular insufficiency of the lower limbs (leg pain, Leriche syndrome, edema of legs, thrombophlebitis). The single most useful diagnostic procedure in suspected cases of retroperitoneal fibrosis is intravenous pyelography. Typical deviation and obstruction of one or both ureters may be observed.

A similar nonspecific fibrotic process, limited to the pleural and immediately subjacent pulmonary tissues, usually presents clinically with dyspnea, tightness and pain in the chest, pleural friction rubs, and pleural effusion. These findings may be confirmed by chest X-ray.

Nonrheumatic fibrotic thickenings of the aortic root and of the aortic and mitral valves usually present clinically with cardiac murmurs and dyspnea.

Several cases of fibrotic plaques, simulating Peyronie’s Disease have been described.

2)      Cardiovascular Complications

Encroachment of retroperitoneal fibrosis on the aorta, inferior vena cava and their common iliac branches may result in vascular insufficiency of the lower limbs, the presenting features of which are mentioned under Retroperitoneal Fibrosis.

Intrinsic vasoconstriction of large and small arteries, involving one or more vessels or merely a segment of a vessel, may occur at any stage of therapy. Depending on the vessel involved, this complication may present with chest pain, abdominal pain, or cold, numb, painful extremities with or without paresthesias and diminished or absent pulses. Progression to ischemic tissue damage has rarely been reported. Prompt withdrawal of the drug at the first signs of impaired circulation is recommended to obviate such effects.

Postural hypotension and tachycardia have also been observed.

3)      Gastrointestinal Symptoms

Nausea, vomiting, diarrhea, heartburn, abdominal pain. These effects tend to appear early and can frequently be obviated by gradual introduction of the medication and by administration of the drug with meals. Constipation and elevation of gastric HCl have also been reported.

4)      CNS Symptoms

Seizure, insomnia, drowsiness, mild euphoria, dizziness, ataxia, lightheadedness, hyperesthesia, unworldly feelings (described variously as “dissociation”, “hallucinatory experiences”, etc.). Some of these symptoms may be associated with vascular headaches, per se, and may, therefore, be unrelated to the drug.

5)      Dermatological Manifestations

Facial flush, telangiectasia, and nonspecific rashes have rarely been reported. Increased hair loss may occur, but in many instances the tendency has abated despite continued therapy.

6)      Edema

Peripheral edema, and, more rarely, localized brawny edema may occur.

Dependent edema has responded to lowered doses, salt restriction, or diuretics.

7)      Weight Gain

Weight gain may be a reason to caution patients regarding their caloric intake.

8)      Hematological Manifestations

Neutropenia, eosinophilia, and thrombocytopenia.

9)      Miscellaneous

Weakness, arthralgia, myalgia, fever, and mydriasis.

Side Effects by Body System

General

General side effects including fibrotic changes have been reported in the retroperitoneal, pleuropulmonary, cardiac, and other tissues. Retroperitoneal fibrosis is usually confined to the retroperitoneal connective tissue above the pelvic brim and may present with symptoms of malaise, fatigue, weight loss, backache, low grade fever, urinary obstruction, and vascular insufficiency. Several cases of fibrotic plaques, simulating Peyronie's disease have also been reported.

Respiratory

Respiratory side effects including fibrosis limited to the pleural and subjacent pulmonary tissues has been reported. In such instances, patients usually present with dyspnea, tightness and pain in the chest, pleural friction rubs, and pleural effusion.

Cardiovascular

Cardiovascular side effects including fibrotic changes such as nonrheumatic thickening of the aortic root and aortic and mitral valves have been reported. Encroachment of retroperitoneal fibrosis on the aorta, inferior vena cava and their common iliac branches may result in vascular insufficiency of the lower limbs. Intrinsic vasoconstriction of large and small arteries may occur at any stage of therapy. Progression to ischemic tissue damage has rarely been reported.

Postural hypotension and tachycardia have also been reported.

Gastrointestinal

Gastrointestinal symptoms including nausea, vomiting, diarrhea, heartburn, constipation, elevated gastric acid, and abdominal pain have been reported.

Nervous system

Nervous system side effects have included seizure, insomnia, drowsiness, mild euphoria, dizziness, ataxia, lightheadedness, hyperesthesia, and feelings of dissociation or hallucinations.

Dermatologic

Dermatologic side effects including facial flushing, telangiectasia, and nonspecific rashes have been reported rarely. Increased hair loss may also occur.

Hematologic

Hematologic side effects have included neutropenia, eosinophilia, and thrombocytopenia.

Musculoskeletal

Musculoskeletal side effects including arthralgia and myalgia have been reported.

Ocular

Ocular side effects including mydriasis have been reported.

Other

Other side effects have included peripheral edema, weakness, weight gain, and fever.

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