Colesevelam

Common brands: Welchol, Aspirin 325, Aspirin 81, Ecotrin, Bayer Low Dose

Top reporter: Cosette Pharmaceuticals, Inc.

Nonsteroidal Anti-inflammatory Drug [EPC]Platelet Aggregation Inhibitor [EPC]Provitamin D2 Compound [EPC]Corticosteroid [EPC]Benzodiazepine [EPC]
9,134
Total Reports
1,242
Serious Reports
277
Death Reports
30
Reported Reactions
Death Report Ratio: Moderate (3.03%)

Patient Demographics

Male
2,891
Female
5,415

Reported Adverse Reactions (30)

Side effects reported in FDA adverse event reports for Colesevelam.

# Reaction Reports % of Total
1 OFF LABEL USE 1,385
12.7%
2 NO ADVERSE EVENT 922
8.4%
3 DIARRHOEA 690
6.3%
4 NAUSEA 515
4.7%
5 FATIGUE 507
4.6%
6 DRUG INEFFECTIVE 483
4.4%
7 CONSTIPATION 395
3.6%
8 DYSPNOEA 380
3.5%
9 HEADACHE 373
3.4%
10 MUSCLE SPASMS 338
3.1%
11 PAIN 333
3.1%
12 ARTHRALGIA 316
2.9%
13 DIZZINESS 298
2.7%
14 MYALGIA 296
2.7%
15 WEIGHT DECREASED 295
2.7%
16 PRURITUS 269
2.5%
17 ASTHENIA 259
2.4%
18 COUGH 258
2.4%
19 FLUSHING 242
2.2%
20 INCORRECT DOSE ADMINISTERED 242
2.2%
21 PAIN IN EXTREMITY 239
2.2%
22 MALAISE 237
2.2%
23 VOMITING 236
2.2%
24 BACK PAIN 223
2.0%
25 FALL 213
2.0%
26 NASOPHARYNGITIS 213
2.0%
27 ABDOMINAL PAIN 197
1.8%
28 ATRIAL FIBRILLATION 191
1.8%
29 ABDOMINAL DISCOMFORT 184
1.7%
30 RASH 183
1.7%

Important Disclaimer

FDA adverse event reports are submitted voluntarily and do not prove causation. A reported reaction does not mean the drug caused it. Drugs with more users naturally have more reports. Always consult your doctor or pharmacist before making medication decisions.