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Naloxone Side Effects

The most commonly reported side effects of naloxone include drug dependence, drug withdrawal syndrome, and pain, based on 43,757 FDA adverse event reports from 2004 to 2025. 3.9% of reports found the drug to be ineffective.

Naloxone side effects

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

1
Drug Dependence11.1%4,841
2
Drug Withdrawal Syndrome8.6%3,784
3
Pain8.0%3,494
4
Nausea6.7%2,943
5
Off Label Use6.6%2,896
6
Overdose5.9%2,592
7
Vomiting5.0%2,182
8
Anxiety4.2%1,855
9
Emotional Distress4.2%1,852
10
Drug Ineffective3.9%1,703
11
Headache3.7%1,637
12
Drug Abuse3.7%1,599
13
Toxicity To Various Agents3.4%1,481
14
Fatigue3.4%1,473
15
Foetal Exposure During Pregnancy3.2%1,403

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

Report severity

70.5%Serious30,859 reports
29.9%Hospitalizations13,083 reports
9.8%Fatal4,293 reports

Seriousness is determined by the reporter, not by OpenClaim.

Naloxone drug interactions

Other drugs that appear in adverse event reports alongside naloxone. 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
Buprenorphine60.0%26,236
2
Oxycodone12.8%5,606
3
Acetaminophen8.4%3,685
4
Hydrocodone6.5%2,847
5
Fentanyl5.0%2,176
6
Hydromorphone-hydrochloride4.7%2,038
7
Morphine-sulfate4.1%1,787
8
Methadone-hydrochloride3.5%1,551
9
Tramadol-hydrochloride3.4%1,467
10
Alprazolam1.7%743
11
Gabapentin1.5%666
12
Nicotine1.5%644
13
Diazepam1.4%630
14
Amphetamine1.4%612
15
Pregabalin1.3%589

Taken alongside

1
Oxycodone12.6%5,528
2
Buprenorphine11.3%4,929
3
Acetaminophen9.5%4,149
4
Ondansetron7.0%3,051
5
Gabapentin6.8%2,995
6
Albuterol5.6%2,445
7
Pantoprazole-sodium5.5%2,416
8
Aspirin4.8%2,097
9
Omeprazole4.8%2,082
10
Ergocalciferol4.7%2,049
11
Furosemide4.6%2,009
12
Levothyroxine-sodium4.0%1,741
13
Atorvastatin-calcium3.7%1,608
14
Ibuprofen3.7%1,601
15
Pregabalin3.6%1,575

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 naloxone side effects

44.8% of naloxone adverse event reports involve female patients and 41.8% involve male patients. The largest age group is adult at 75%. These figures reflect who reports side effects, not underlying risk.

Sex

Female44.8%
Male41.8%
Unknown13.5%

Age group

< 24.1%
2–111.0%
12–171.2%
18–6475.3%
65+18.4%

What is naloxone used for

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

Abdominal DiscomfortAbdominal PainAbdominal Pain LowerAbdominal Pain UpperAccidentAccidental Drug Intake By ChildAccidental ExposureAccidental Exposure To ProductAccidental Exposure To Product By ChildAccidental OverdoseAcetabulum FractureAcneAcute Respiratory Distress SyndromeAcute Respiratory FailureAdjuvant Therapy

Showing 15 of 706 indications

Naloxone brand names and reporting trend

Naloxone is sold under the brand name Kloxxado.

Brand names

Kloxxado128

Quarterly reports (20042025)

20052010201520202025

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

Taking naloxone with another medication?

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