What are the most common side effects of BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE?

Reported side effects vary by individual. The side-effects section on this page lists the events most frequently reported to FDA FAERS for BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE. FAERS is voluntary reporting, so it reflects what was reported, not absolute incidence.

Is BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE the same as Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate?

Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate is a brand name for BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE. They share the same active ingredient and FDA-approved indications. Biosimilars and authorised generics may differ in inactive ingredients such as buffers or preservatives.

BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE

Opioid Analgesic

Brand names: Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate

Sublingual

Mechanism of Action

12.1 Mechanism of Action Buprenorphine and naloxone sublingual tablets contain buprenorphine and naloxone. Buprenorphine is a partial agonist at the mu-opioid receptor and an antagonist at the kappa-opioid receptor. Naloxone is an opioid antagonist and produces opioid withdrawal signs and symptoms in individuals physically dependent on full opioid agonists when administered parenterally.

Indications

a partial opioid agonist

and naloxone

an opioid antagonist

Contraindications

• 4 CONTRAINDICATIONS Buprenorphine and naloxone sublingual tablets are contraindicated in patients with a history of hypersensitivity to buprenorphine or naloxone as serious adverse reactions
• including anaphylactic shock
• have been reported [see Warnings and Precautions (5.9) ] . Hypersensitivity to buprenorphine or naloxone. ( 4 )

FDA Warnings

5 WARNINGS AND PRECAUTIONS Addiction, Abuse, and Misuse: Buprenorphine can be abused in a similar manner to other opioids
1 ) Respiratory Depression: Life-threatening respiratory depression and death have occurred in association with buprenorphine use
Buprenorphine can cause severe, possibly fatal, respiratory depression in children
6 ) Risk of Opioid Withdrawal with Abrupt Discontinuation: If treatment is temporarily interrupted or discontinued, monitor patients for withdrawal and treat appropriately

Known Side Effects

5 documented side effects by frequency

Drug Not Working

1-10%

Nausea

1-10%

Vomiting

0.1-1%

Headache

0.1-1%

Dizziness

0.1-1%

Community Discussions

2 Reddit threads analysed for BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE

Overall Sentiment

Mixed

Comparison Threads

Avg Post Score

66 upvotes

Patient Experiences (r/pharmacy, r/AskDocs & more)

More heirloom pharmaceuticals

r/pharmacy11871y ago

What's the difference between diphenhydramine hydrochloride and diphenhydramine citrate?

I've noticed that OTC medications such as Tylenol PM and Aleve PM have diphenhydramine hydrochloride in them, whereas Advil PM has diphenhydramine citrate. What's the difference between the two? Is diphenhydramine HCl more potent than citrate? I've noticed that the Tylenol/Aleve PM that have HCl onl

r/pharmacy1499y ago

Community discussions are sourced from public Reddit threads. Content reflects individual opinions and is not medical advice.

Primary sources

Every figure on this page links back to its primary source. See data sources for full provenance.

DailyMed FDA label search → BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE openFDA label JSON → BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE FAERS adverse-event reports → BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE ClinicalTrials.gov → completed Phase 2+ trials of BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE

Compare With

15 available comparisons

Formulations

Dosage Forms

Tablet

Route

Sublingual