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Naldemedine Side Effects

The most commonly reported side effects of naldemedine include diarrhoea, nausea, and constipation, based on 1,659 FDA adverse event reports from 2014 to 2025. 6.7% of reports found the drug to be ineffective.

Naldemedine side effects

Percentages show how often each reaction appears relative to total reports for naldemedine.

1
Diarrhoea11.3%188
2
Nausea7.8%129
3
Constipation6.8%113
4
Drug Ineffective6.7%111
5
Malignant Neoplasm Progression5.7%94
6
Abdominal Pain5.2%87
7
Interstitial Lung Disease4.8%79
8
Decreased Appetite4.6%76
9
Malaise4.4%73
10
Pyrexia4.0%66
11
Anaemia4.0%66
12
Vomiting3.4%57
13
Death3.1%51
14
Febrile Neutropenia3.1%51
15
Hepatic Function Abnormal3.0%50

These are voluntary reports and do not establish that naldemedine caused these reactions.

Report severity

74.7%Serious1,239 reports
41.8%Hospitalizations694 reports
28.0%Fatal464 reports

Seriousness is determined by the reporter, not by OpenClaim.

Naldemedine drug interactions

Other drugs that appear in adverse event reports alongside naldemedine. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Pembrolizumab10.1%167
2
Nivolumab7.5%125
3
Oxycodone5.5%91
4
Carboplatin4.8%79
5
Atezolizumab4.3%71
6
Paclitaxel4.2%70
7
Ipilimumab3.3%54
8
Lenvatinib-mesylate3.1%52
9
Bevacizumab3.0%49
10
Pemetrexed2.4%39
11
Prednisone1.9%31
12
Doxorubicin-hydrochloride1.8%30
13
Cabozantinib1.6%27
14
Methadone-hydrochloride1.6%26
15
Lenalidomide1.6%26

Taken alongside

1
Oxycodone31.6%524
2
Magnesium-oxide21.0%349
3
Acetaminophen13.5%224
4
Pregabalin12.7%210
5
Lansoprazole11.1%184
6
Dexamethasone10.4%172
7
Amlodipine10.1%168
8
Fentanyl9.5%157
9
Vonoprazan-fumarate7.9%131
10
Esomeprazole7.5%124
11
Hydromorphone-hydrochloride7.2%120
12
Furosemide6.6%110
13
Celecoxib6.6%109
14
Levothyroxine-sodium5.7%94
15
Pantoprazole-sodium5.6%93

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports naldemedine side effects

41.6% of naldemedine adverse event reports involve female patients and 48.8% involve male patients. The largest age group is elderly at 56%. These figures reflect who reports side effects, not underlying risk.

Sex

Female41.6%
Male48.8%
Unknown9.6%

Age group

< 20.0%
2–11<0.1%
12–170.2%
18–6444.2%
65+55.6%

What is naldemedine used for

Conditions and purposes for which patients were taking naldemedine when the adverse event was reported.

Adenocarcinoma PancreasAstringent TherapyBreast CancerBreast Cancer RecurrentCancer PainConstipationConstipation ProphylaxisCancer PainChemotherapyConstipationConstipation ProphylaxisDiarrhoeaEosinophilic Granulomatosis With PolyangiitisEmbolismFibromyalgia

Showing 15 of 50 indications

Naldemedine brand names and reporting trend

Naldemedine is sold under the brand name Symproic.

Brand names

Symproic343

Quarterly reports (20142025)

2014202020242025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking naldemedine with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.