SFROWASA (mesalamine)

There are 0 contraindications.

There are 2 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Interstitial nephritis
Minimal change glomerulonephritis

There are 4 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
Atopic dermatitis
Disease of liver
Kidney disease with likely reduction in glomerular filtration rate (GFr)
Kidney disease with reduction in glomerular filtration rate (GFr)

There are 37 severe adverse reactions.

More Frequent	Less Frequent
None.	None.

Rare/Very Rare

Abnormal hepatic function tests Acute generalized exanthematous pustulosis Acute pancreatitis Agranulocytosis Alveolitis Aplastic anemia Bloody diarrhea Colitis DRESS syndrome Eosinophilia Erythema nodosum Gastrointestinal hemorrhage Guillain-barre syndrome Hepatic failure Hepatic necrosis Hepatitis Hypersensitivity drug reaction Hypersensitivity pneumonitis Interstitial nephritis Intracranial hypertension Jaundice Kidney disease with reduction in glomerular filtration rate (GFr) Kidney stone Lupus-like syndrome Myelitis Myocarditis Nephrogenic diabetes insipidus Obstructive hyperbilirubinemia Pancytopenia Pericarditis Pleuritis Pyoderma gangrenosum Rectal irritation Skin photosensitivity Stevens-johnson syndrome Thrombocytopenic disorder Toxic epidermal necrolysis

There are 31 less severe adverse reactions.

More Frequent	Less Frequent
Abdominal pain with cramps Headache disorder	Abdominal distension Acne vulgaris Diarrhea Dizziness Fatigue Fever Flatulence Flu-like symptoms Gastritis Nausea Pruritus ani Rectal pain Skin rash

Rare/Very Rare
Alopecia Back pain Constipation Discolored feces Erythema Female infertility Hemorrhoids Oligospermia Pain in extremities Periorbital edema Peripheral neuropathy Pruritus of skin Psoriasis Tenesmus Urine discoloration Urticaria

Reproduction studies in rats and rabbits using oral mesalamine dosages of up to 1000 mg/kg daily and up to 800 mg/kg daily, respectively, have not revealed evidence of teratogenic effects or harm to the fetus. In addition, reproduction studies in rats and rabbits using oral mesalamine daily doses up to 5 and 8 times the maximum recommended human rectal dose, respectively, have not revealed evidence of fetal malformation. Sulfasalazine (a prodrug of mesalamine) has been used for the treatment of inflammatory bowel disease, including Crohn's disease and ulcerative colitis, during pregnancy.

Although fetal abnormalities have been reported in infants born to women with inflammatory bowel disease who received sulfasalazine alone or combined with corticosteroids during pregnancy, most evidence indicates that sulfasalazine is not associated with a substantial risk of teratogenicity. The effect of sulfasalazine on subsequent growth, development, and functional maturation in children whose mothers received sulfasalazine during pregnancy has not been determined. Although the relevance to mesalamine of the experience with sulfasalazine in pregnant women currently is not known, placental transfer of mesalamine, but not sulfasalazine or sulfapyridine, has been reported to be negligible in pregnant women receiving oral sulfasalazine.

Mesalamine crosses the placental barrier. Because there are no adequate and controlled studies to date using mesalamine or sulfasalazine in pregnant women, and animal studies are not always predictive of human response, the drugs should be used during pregnancy only when clearly needed.

Following oral administration, low concentrations of mesalamine and higher concentrations of its N-acetyl metabolite have been detected in human breast milk. Although the clinical importance of this effect is not known, mesalamine should be used with caution and only if the benefits outweigh the risks in nursing women. The manufacturer of mesalamine extended-release capsules states that hypersensitivity reactions (e.g., diarrhea) in the infant of a breast-feeding woman receiving mesalamine cannot be excluded. The manufacturer of mesalamine rectal suspension recommends that the drug not be used in nursing women.

No enhanced Geriatric Use information available for this drug.