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Apriso (Mesalamine) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

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 TermAPRISO
1.5g/day
N=367

Placebo
N=185
Headache11%8%
Diarrhea8%7%
Abdominal Pain Upper5%3%
Nausea4%3%
Nasopharyngitis4%3%
Influenza & Influenza-like illness4%4%
Sinusitis3%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



REPORTS OF SUSPECTED APRISO SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Apriso. The information is not vetted and should not be considered as verified clinical evidence.

Possible Apriso side effects / adverse reactions in 19 year old male

Reported by a consumer/non-health professional from United States on 2012-01-27

Patient: 19 year old male weighing 84.4 kg (185.8 pounds)

Reactions: Weight Decreased, Frequent Bowel Movements, Diarrhoea, Drug Ineffective, Crohn's Disease

Adverse event resulted in: hospitalization

Suspect drug(s):
Apriso
    Indication: Crohn's Disease

Balsalazide Disodium
    Indication: Crohn's Disease
    Start date: 2009-01-01

Humira
    Indication: Crohn's Disease
    Start date: 2010-05-25

Mesalamine
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Prednisone TAB; Fluconazole; Mercaptopurine



Possible Apriso side effects / adverse reactions in 70 year old male

Reported by a physician from United States on 2012-04-19

Patient: 70 year old male

Reactions: Myocardial Infarction

Adverse event resulted in: death

Suspect drug(s):
Apriso



Possible Apriso side effects / adverse reactions in 59 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-20

Patient: 59 year old female weighing 90.7 kg (199.6 pounds)

Reactions: Nausea, Diarrhoea, Dehydration, Condition Aggravated

Suspect drug(s):
Apriso
    Dosage: 4 caps q morning po
    Administration route: Oral
    Indication: Colitis
    Start date: 2012-07-17
    End date: 2012-08-03

Apriso
    Dosage: 4 caps q morning po
    Administration route: Oral
    Indication: Diverticulum
    Start date: 2012-07-17
    End date: 2012-08-03



See index of all Apriso side effect reports >>

Drug label data at the top of this Page last updated: 2008-11-12

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