Rowasa (Mesalamine) - Side Effects and Adverse Reactions

ADVERSE REACTIONS

Clinical Adverse Experience

ROWASA® (Mesalamine) Rectal Suspension Enema is usually well tolerated. Most adverse effects have been mild and transient.

ADVERSE REACTIONS OCCURRING IN MORE THAN 0.1% OF ROWASA® (MESALAMINE) RECTAL SUSPENSION ENEMA TREATED PATIENTS (COMPARISON TO PLACEBO)

SYMPTOM	ROWASA® N=815 N	%	PLACEBO N=128 N	%
Abdominal Pain/Cramps/Discomfort	66	8.10	10	7.81
Headache	53	6.50	16	12.50
Gas/Flatulence	50	6.13	5	3.91
Nausea	47	5.77	12	9.38
Flu	43	5.28	1	0.78
Tired/Weak/Malaise/Fatigue	28	3.44	8	6.25
Fever	26	3.19	0	0.00
Rash/Spots	23	2.82	4	3.12
Cold/Sore Throat	19	2.33	9	7.03
Diarrhea	17	2.09	5	3.91
Leg/Joint Pain	17	2.09	1	0.78
Dizziness	15	1.84	3	2.34
Bloating	12	1.47	2	1.56
Back Pain	11	1.35	1	0.78
Pain on Insertion of Enema Tip	11	1.35	1	0.78
Hemorrhoids	11	1.35	0	0.00
Itching	10	1.23	1	0.78
Rectal Pain	10	1.23	0	0.00
Constipation	8	0.98	4	3.12
Hair Loss	7	0.86	0	0.00
Peripheral Edema	5	0.61	11	8.59
UTI/Urinary Burning	5	0.61	4	3.12
Rectal Pain/Soreness/Burning	5	0.61	3	2.34
Asthenia	1	0.12	4	3.12
Insomnia	1	0.12	3	2.34

In addition, the following adverse events have been identified during post-approval use of products which contain (or are metabolized to) mesalamine in clinical practice: nephrotoxicity, pancreatitis, fibrosing alveolitis and elevated liver enzymes. Cases of pancreatitis and fibrosing alveolitis have been reported as manifestations of inflammatory bowel disease as well. Published case reports and/or spontaneous post marketing surveillance have described rare instances of aplastic anemia, agranulocytosis, thrombocytopenia, eosinophilia, pancytopenia, neutropenia, oligospermia, and infertility in men. Anemia, leukocytosis, and thrombocytosis can be part of the clinical presentation of inflammatory bowel disease.

Hair Loss

Mild hair loss characterized by "more hair in the comb" but no withdrawal from clinical trials has been observed in 7 of 815 mesalamine patients but none of the placebo-treated patients. In the literature there are at least six additional patients with mild hair loss who received either mesalamine or sulfasalazine. Retreatment is not always associated with repeated hair loss.

REPORTS OF SUSPECTED ROWASA SIDE EFFECTS / ADVERSE REACTIONS

Possible Rowasa side effects / adverse reactions in 37 year old male

Reported by a consumer/non-health professional from United States on 2012-05-25

Patient: 37 year old male weighing 83.0 kg (182.6 pounds)

Reactions: Diplopia, Central Nervous System Lesion, Deafness Unilateral, Vitamin D Decreased, Vertigo, Paraesthesia

Suspect drug(s):
Rowasa
    Dosage: 1 application (dose) (at night)
    Indication: Colitis Ulcerative
    Start date: 2012-02-01

Remicade
    Dosage: iv
    Indication: Colitis Ulcerative
    Start date: 2007-04-01
    End date: 2012-01-01

Other drugs received by patient: Multivitamins (Vitamins, Minerals)

Possible Rowasa side effects / adverse reactions in 54 year old female

Reported by a health professional (non-physician/pharmacist) on 2012-06-26

Patient: 54 year old female

Reactions: Night Sweats, Productive Cough, General Physical Condition Abnormal, Lung Disorder, Colitis Ulcerative, Obliterative Bronchiolitis

Adverse event resulted in: hospitalization

Suspect drug(s):
Rowasa