Linaclotide

Common brands: Linzess, Vitamin D, Acid Reducer, Neurontin, Gralise

Top reporter: Allergan, Inc.

Guanylate Cyclase-C Agonist [EPC]Nonsteroidal Anti-inflammatory Drug [EPC]Benzodiazepine [EPC]Proton Pump Inhibitor [EPC]Osmotic Laxative [EPC]
25,697
Total Reports
10,851
Serious Reports
1,036
Death Reports
30
Reported Reactions
Death Report Ratio: Moderate (4.03%)

Patient Demographics

Male
6,337
Female
17,031

Reported Adverse Reactions (30)

Side effects reported in FDA adverse event reports for Linaclotide.

# Reaction Reports % of Total
1 DIARRHOEA 4,580
14.1%
2 DRUG INEFFECTIVE 4,430
13.6%
3 OFF LABEL USE 3,279
10.1%
4 CONSTIPATION 1,937
6.0%
5 NAUSEA 1,414
4.3%
6 FATIGUE 1,143
3.5%
7 ABDOMINAL DISTENSION 1,134
3.5%
8 ABDOMINAL PAIN 1,041
3.2%
9 HEADACHE 1,007
3.1%
10 PAIN 928
2.9%
11 ABDOMINAL PAIN UPPER 908
2.8%
12 DIZZINESS 818
2.5%
13 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION 739
2.3%
14 FLATULENCE 688
2.1%
15 FALL 679
2.1%
16 DYSPNOEA 651
2.0%
17 MALAISE 644
2.0%
18 ASTHENIA 622
1.9%
19 VOMITING 620
1.9%
20 PRODUCT DOSE OMISSION ISSUE 559
1.7%
21 INTENTIONAL PRODUCT MISUSE 518
1.6%
22 DEATH 515
1.6%
23 WEIGHT DECREASED 501
1.5%
24 ANXIETY 469
1.4%
25 ARTHRALGIA 463
1.4%
26 RASH 463
1.4%
27 ABDOMINAL DISCOMFORT 452
1.4%
28 INCORRECT DOSE ADMINISTERED 447
1.4%
29 PRURITUS 439
1.4%
30 MUSCLE SPASMS 425
1.3%

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.