Naltrexone Side Effects
For healthcare professionals
Applies to naltrexone: compounding powder, intramuscular powder for injection extended release, oral capsule, oral tablet.
Nervous system adverse events
- Very common (10% or more): Headache (25%), dizziness/syncope (13%)
- Common (1% to 10%): Somnolence/sedation
- Frequency not reported: Lethargy, cerebral arterial aneurysm, convulsions, disturbance in attention, dysgeusia, mental impairment, migraine, ischemic stroke, paresthesia[Ref]
Psychiatric
- Very common (10% or more): Insomnia/sleep disorder (14%), anxiety (12%)
- Common (1% to 10%): Depression
- Uncommon (0.1% to 1%): Suicide attempt/ideation
- Frequency not reported: Irritability, abnormal dreams, agitation, alcohol withdrawal syndrome, euphoric mood, delirium, libido decreased[Ref]
Gastrointestinal
- Very common (10% or more): Nausea (33%), vomiting NOS (14%), diarrhea (13%), abdominal pain (11%)
- Common (1% to 10%): Dry mouth, toothache
- Frequency not reported: Abdominal discomfort, colitis, constipation, flatulence, gastroesophageal reflux disease, gastrointestinal hemorrhage, hemorrhoids, pancreatitis acute, paralytic ileus[Ref]
Hepatic
- Very common (10% or more): Alanine aminotransferase increased (13%), aspartate aminotransferase increased (10%)
- Common (1% to 10%): Gamma-glutamyltransferase increased
- Frequency not reported: Lymphadenopathy including cervical adenitis, white blood cell count increased, cholecystitis acute, cholelithiasis[Ref]
Local
- Very common (10% or more): Injection site tenderness (45%), injection site induration (35%), injection site pain (17%), other injection site reaction (primarily nodules, swelling) (15%), injection site pruritus (10%)
- Common (1% to 10%): Injection site ecchymosis[Ref]
Musculoskeletal
- Very common (10% or more): Arthralgia/arthritis/joint stiffness (12%)
- Common (1% to 10%): Back pain/stiffness, muscle cramps
- Frequency not reported: Chills, joint stiffness, muscle spasms, myalgia, pain in limb[Ref]
Other
- Very common (10% or more): Asthenic conditions (23%)
- Frequency not reported: Chest pain, chest tightness, abortion missed[Ref]
Cardiovascular
- Frequency not reported: Angina pectoris, angina unstable, atrial fibrillation, cardiac failure congestive, coronary artery atherosclerosis, myocardial infarction, palpitations, deep vein thrombosis[Ref]
Respiratory
- Frequency not reported: Chronic obstructive pulmonary disease, dyspnea, pharyngolaryngeal pain, sinus congestion[Ref]
Dermatologic
- Common (1% to 10%): Rash
- Frequency not reported: Face edema, night sweats, pruritus, sweating increased[Ref]
Metabolic
- Very common (10% or more): Anorexia/appetite decreased NOS/appetite disorder NOS (14%)
- Frequency not reported: Weight decreased, weight increased, appetite increased, dehydration[Ref]
Renal
- Very common (10% or more): Abnormal creatinine phosphokinase levels (17%)[Ref]
Hematologic
- Frequency not reported: Eosinophil counts increased, decreased platelet count[Ref]
Ocular
- Frequency not reported: Conjunctivitis, vision blurred[Ref]
Hypersensitivity
- Frequency not reported: Hypersensitivity reaction (including angioneurotic edema and urticaria)
- Postmarketing reports: Anaphylaxis[Ref]
Immunologic
- Very common (10% or more): Pharyngitis (11%)
- Common (1% to 10%): Nasopharyngitis
- Frequency not reported: Seasonal allergies[Ref]
References
1. (2018) "Product Information. Vivitrol (naltrexone)." Alkermes, Inc
2. (2018) "Product Information. Naltrexone Hydrochloride (naltrexone)." Accord Biopharma Inc
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Naltrexone side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.