Apriso Side Effects

Generic Name: mesalamine

Please note - some side effects for Apriso may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Apriso - for the Consumer

Apriso Extended-Release Capsules

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Apriso Extended-Release Capsules:

Diarrhea; headache; mild abdominal discomfort or pain; nausea; runny or stuffy nose.

Seek medical attention right away if any of these SEVERE side effects occur when using Apriso Extended-Release Capsules:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in the urine; bloody diarrhea; bloody or coffee ground-like vomit; change in amount of urine; chest pain; dark urine; fever, chills, or persistent sore throat; severe or persistent headache; severe or sudden stomach pain or cramping; sudden shortness of breath; unusual bruising or bleeding; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Apriso Side Effects - for the Professional

Apriso

Clinical Studies Experience

The data described below reflect exposure to Apriso in 557 patients, including 354 exposed for at least 6 months and 250 exposed for greater than one year. Apriso was studied in two placebo-controlled trials (n = 367 treated with Apriso) and in one open-label, long-term study (n = 190 additional patients). The population consisted of patients with ulcerative colitis; the mean age was 47 years, 54% were female, and 93% were white. Patients received doses of Apriso 1.5 g administered orally once per day for six months in the placebo-controlled trials and for up to 24 months in the open-label study.

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In the two placebo-controlled trials, 59% of Apriso-treated patients experienced an adverse reaction compared with 64% of placebo patients. Most adverse reactions with Apriso were mild or moderate in severity. Severe adverse reactions occurred in 6% of Apriso-treated patients and 5% of placebo-treated patients. Discontinuations due to adverse reactions occurred in 11% of Apriso-treated patients and 17% of placebo-treated patients; the most common adverse reaction resulting in study discontinuation was recurrence of ulcerative colitis (Apriso 6%, placebo 14%). The most common reactions reported with Apriso (≥3%) are shown in Table 1 below.

Table 1: Treatment-Emergent Adverse Reactions during Clinical Trials Occurring in at Least 3% of Apriso-Treated Patients and at a Greater Rate than with Placebo

MedDRA Preferred Term	Apriso 1.5g/day  N=367	Placebo N=185
Headache	11%	8%
Diarrhea	8%	7%
Abdominal Pain Upper	5%	3%
Nausea	4%	3%
Nasopharyngitis	4%	3%
Influenza & Influenza-like illness	4%	4%
Sinusitis	3%	3%

The following adverse reactions, presented by body system, were reported at a frequency less than 3% in patients treated with Apriso for up to 24 months in controlled and open-label trials.

Ear and Labyrinth Disorders: tinnitus, vertigo

Dermatological Disorder: alopecia

Gastrointestinal: abdominal pain lower, rectal hemorrhage

Laboratory Abnormalities: increased triglycerides, decreased hematocrit and hemoglobin

General Disorders and Administration Site Disorders: fatigue

Hepatic: hepatitis cholestatic, transaminases increased

Renal Disorders: creatinine clearance decreased, hematuria

Musculoskeletal: pain, arthralgia

Respiratory: dyspnea

Adverse Reaction Information from Other Sources

The following adverse reactions have been identified during clinical trials of a product similar to Apriso and post approval use of other mesalamine-containing products such as Apriso.  Because many of these reactions are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Body as a Whole: lupus-like syndrome, drug fever

Cardiovascular:  pericarditis, pericardial effusion, myocarditis

Gastrointestinal: pancreatitis, cholecystitis, gastritis, gastroenteritis, gastrointestinal bleeding, perforated peptic ulcer

Hepatic: jaundice, cholestatic jaundice, hepatitis, liver necrosis, liver failure, Kawasaki-like syndrome including changes in liver enzymes

Hematologic: agranulocytosis, aplastic anemia

Neurological/Psychiatric: peripheral neuropathy, Guillain-Barré syndrome, transverse myelitis

Respiratory/Pulmonary: eosinophilic pneumonia, interstitial pneumonitis

Skin: psoriasis, pyoderma gangrenosum, erythema nodosum

Renal/Urogenital: reversible oligospermia

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Side Effects by Body System - for Healthcare Professionals

Gastrointestinal

Gastrointestinal side effects have frequently included abdominal pain (up to 18%), eructation (up to 16%), nausea (up to 13%), diarrhea (up to 8%), dyspepsia (up to 6%), ulcerative colitis (up to 5.8%), vomiting (up to 5%), constipation (up to 5%), upper abdominal pain (up to 5%), gastrointestinal bleeding (up to 5% or greater), flatulence (up to 5% or greater), colitis exacerbation (up to 3%), lower abdominal pain (less than 3%), rectal hemorrhage (less than 3%), gastroenteritis (2% or greater), stool abnormalities (color or texture change; up to 2% or greater), tenesmus (up to 2% or greater), rectal disorder (2% or greater), abdominal enlargement (up to 2% or greater), and abdominal distention (up to 1.3%). Infrequently, colitis, pancreatitis, rectal polyp, anorexia, duodenal ulcer, esophageal ulcer, dysphagia, fecal incontinence, oral moniliasis, thirst, bloody diarrhea, recurrence of ulcerative colitis, gastritis, increased appetite, cholecystitis, dry mouth, stomatitis, taste perversion, and perforated peptic ulcer (rare) have been reported. Colitis symptoms (including cramping, acute abdominal pain, and bloody diarrhea, and occasionally fever, headache, malaise, pruritus, rash, and conjunctivitis) have been exacerbated after starting mesalamine or sulfasalazine in 3% of patients in controlled clinical trials. This acute intolerance syndrome may be difficult to distinguish from a flare of inflammatory bowel disease. Worsening of colitis or symptoms of inflammatory bowel disease, including melena and hematochezia, have also been reported after commencing mesalamine rectal suspension enema. Pancreatitis, cholecystitis, gastritis, gastroenteritis, gastrointestinal bleeding, and perforated peptic ulcer have been reported during postmarketing experience.

Nervous system

Nervous system side effects have included headache (up to 35%), dizziness (up to 8%), lightheadedness (8%), faintness (8%), tinnitus (less than 3%), vertigo (less than 3%), migraine (2% or greater), paresthesia (up to 2% or greater), insomnia (up to 2%). Infrequently, somnolence, tremor, hyperesthesia, peripheral neuropathy (rare), Guillain-Barre syndrome (rare), transverse myelitis (rare), and benign intracranial hypertension (at least 1 case) have been reported. Systemic lupus erythematosus, peripheral neuropathy, Guillain-Barre syndrome, and transverse myelitis have also been reported during postmarking experience.

A 23-year-old female with ulcerative colitis who had been taking 400 mg mesalamine tablets three times a day developed benign intracranial hypertension. The examination disclosed benign intracranial hypertension that resolved when mesalamine was discontinued and recurred when the drug was restarted.

Musculoskeletal

Musculoskeletal side effects have included muscle aches (21%), arthralgia (up to 5% or greater), hypertonia (5%), myalgia (up to 3%), joint disorder (2% or greater), arthritis (2%), back pain (up to 1.2%), gout, leg cramps, and rheumatoid arthritis.

Respiratory

A 72-year-old female with ulcerative colitis who had begun taking two 400 mg mesalamine tablets twice daily experienced pleural effusion and pulmonary infiltrates. Chest radiograph showed bilateral pleural effusions and an infiltrate in the lower lobe of the right lung. It was determined that the adverse events described appeared likely to be due to mesalamine therapy.

Respiratory side effects have included nasopharyngitis (up to 11%), rhinitis (up to 9%), influenza and influenza-like illness (up to 5% or greater), sinusitis (3%), dyspnea (less than 3%), bronchitis (2% or greater), increased cough (2%), eosinophilic pneumonia, interstitial pneumonitis, asthma exacerbation, and pleuritis. Pleural effusion and pulmonary infiltrates, generally accompanied by eosinophilia, have been reported rarely. More severe cases have included fibrosing alveolitis. Pneumonitis and hypersensitivity pneumonitis (including interstitial pneumonitis, allergic alveolitis, eosinophilic pneumonitis) have been reported during postmarketing experience.

Cardiovascular

Cardiovascular side effects have included chest pain of unknown etiology (3%), vasodilation (up to 2% or greater), and hypertension (up to 1%). Infrequently, tachycardia, hypotension, palpitations, pericarditis, pericardial effusion, myocarditis (rare), T-wave abnormalities (rare), severe symptomatic sinus bradycardia (at least 1 case), and pleuropericarditis (at least 1 case) have been reported. Angioedema, myocarditis, pericardial effusion, and pericarditis have been reported during postmarketing experience.

One 20-year-old patient died of cardiac arrhythmias attributed to myocarditis 13 days after starting mesalamine.

A 56-year-old male with hypertension and ulcerative proctitis experienced pleuropericarditis coincident with mesalamine therapy. Evaluation revealed acute pleuropericarditis manifested by ECG changes, pericardial effusion, and a small pleural effusion. All symptoms resolved when mesalamine was discontinued.

Other

Other side effects have included pain (in various parts of the body; up to 14%), asthenia (up to 7%), fever (up to 6%), chills (3%), peripheral edema (3%), fatigue (up to 3%), ear disorder (2% or greater), infection (2% or greater), malaise (2%), lymphadenopathy, facial edema, pyrexia, edema, lupus-like syndrome, pharyngolaryngeal pain, ear pain, ear congestion, and drug fever (rare). Lupus-like syndrome and drug fever have also been reported during postmarketing experience.

Dermatologic

Dermatologic side effects have included rash (up to 7%), sweating (up to 3%), pruritus (up to 3%), alopecia (less than 3%), and acne (up to 2%). Infrequently, lupus erythematosus-like reactions, prurigo, urticaria, dry skin, eczema, erythema nodosum, lichen planus, nail disorder, photosensitivity, folliculitis (rare), psoriasis (rare), and pyoderma gangrenosum (rare) have been reported. Psoriasis, pyoderma gangrenosum, and erythema nodosum have also been reported during postmarketing experience.

Hematologic

Hematologic side effects have included decreased hematocrit and hemoglobin (less than 3%), thrombocytopenia, eosinophilia, leukopenia, neutropenia, pancytopenia, anemia, ecchymosis, thrombocythemia, decreased platelet count, agranulocytosis (rare), and aplastic anemia (rare). Granulocytopenia, agranulocytosis, and aplastic anemia have also been reported during postmarketing experience.

Hypersensitivity

A male patient with ulcerative colitis experienced pruriginous rash coincident with mesalamine therapy. He experienced the cutaneous hypersensitivity reaction 48 hours after initiating therapy with mesalamine 500 mg orally every 8 hours. After mesalamine was suspended and antihistamines were given, the patient recovered. Upon reintroduction of mesalamine, the symptoms appeared again 24 hours later.

Hypersensitivity side effects have included rash and pruritus (greater than 2%); arthralgias, myalgias, and fever (greater than 1%); and less commonly, allergic reactions (which could involve eosinophilia), hepatitis, interstitial pneumonitis, and pericarditis. Mesalamine-induced cardiac hypersensitivity reactions (myocarditis and pericarditis) and, rarely, hypersensitivity reactions such as hypersensitivity pneumonitis, angioedema, erythroderma, toxic epidermal necrolysis, palmar-plantar erythrodysesthesia, and hypereosinophilia have been reported. At least two cases of pruriginous rash have been reported.

Hepatic

Hypersensitivity hepatitis associated with mesalamine appears to occur less commonly than with sulfasalazine.

A 42-year-old male with ulcerative colitis was admitted for investigation of prolonged fever associated with cholestatic liver tests. Endoscopic retrograde cholangiopancreatography demonstrated a normal biliary tree, and liver biopsy showed granulomata. The symptoms disappeared after cessation of mesalamine therapy and recurred on rechallenge.

Hepatic side effects have included hepatitis. Affected patients have often presented with rash, fever, abdominal pain, nausea, vomiting, chills, dizziness, hepatomegaly, lymphadenopathy, and laboratory abnormalities (including elevated liver function tests, eosinophilia, and leukocytosis). Cholestatic hepatitis (less than 3%), elevated transaminases (less than 3%), abnormal liver function test (up to 2.3%), elevated bilirubin, hepatic impairment, jaundice, cholestatic jaundice, cirrhosis, liver necrosis, liver failure, Kawasaki-like syndrome (including changes in liver enzymes), transient elevations in liver function tests, and at least one case of granulomatous hepatitis have been reported. Hepatic failure has been reported in patients with preexisting liver disease. Hepatitis, jaundice, cholestatic jaundice, liver necrosis, liver failure, and Kawasaki-like syndrome (including changes in liver enzymes) have also been reported during postmarketing experience.

Renal

Renal side effects have included decreased creatinine clearance (less than 3%), interstitial nephritis, minimal change nephropathy, nephrogenic diabetes insipidus, nephrotic syndrome, elevated blood urea nitrogen and serum creatinine, and renal failure (acute and chronic). Renal impairment (including minimal change nephropathy, acute and chronic interstitial nephritis, and, rarely, renal failure) has been reported with products that contain mesalamine or are converted to mesalamine. Renal tubular dysfunction has also been reported, although a definitive causality has not been established. Interstitial nephritis has also been reported during postmarketing experience.

Genitourinary

Genitourinary side effects have included dysmenorrhea (3%), hematuria (less than 3%), urinary frequency (2% or greater), dysuria, albuminuria, amenorrhea, breast pain, hypomenorrhea, menorrhagia, metrorrhagia, urinary urgency, urinary burning, and epididymitis. Rarely, oligospermia and infertility in men have been reported and have been attributed to sulfasalazine. Reversible oligospermia has been reported during postmarketing experience.

Psychiatric

Psychiatric side effects have included anxiety (2% or greater), depression, lethargy, mild disorientation, emotional lability, and decreased libido.

Metabolic

Metabolic side effects have included elevated triglycerides (less than 3%), alkaline phosphatase, amylase, lipase, gamma-glutamyltransferase, and lactate dehydrogenase.

Ocular

Ocular side effects have included vision abnormalities (2% or greater), conjunctivitis (up to 2%), eye pain, and blurred vision.

Local

Local side effects associated with the use of mesalamine enemas have included perianal irritation, pain on insertion of enema tip, hemorrhoids, and rectal pain/soreness/burning.

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