Opium

Belladonna/opium rectal suppository is a combination narcotic analgesic/antispasmodic agent. The belladonna extract component of the rectal suppository provides the active alkaloids atropine and scopolamine, while the opium component provides primarily morphine (among more than 20 alkaloids).

• Belladonna and opium suppositories are indicated for the management of ureteral spasm pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [ see Warnings and Precautions (5.1) ], reserve belladonna and opium suppositories for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: • Have not been tolerated, or are not expected to be tolerated, • Have not provided adequate analgesia, or are not expected to provide adequate analgesic Belladonna and opium suppositories are an opioid agonist indicated for the management of ureteral spasm pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

• • Belladonna and opium suppositories are contraindicated in patients with: • Significant respiratory depression [ see Warnings and Precautions (5.2) ] • Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [ see Warnings and Precautions (5.5) ] • Concurrent use of monoamine oxidase inhibitors (MAOIs) or use of MAOIs within the last 14 days [ see Warnings and Precautions (5.7), Drug Interactions (7) ] • Known or suspected gastrointestinal obstruction, including paralytic ileus [ see Warnings and Precautions (5.9) ] • Hypersensitivity to opium or belladonna [ see Adverse Events (6) ] • Glaucoma 2 • Severe hepatic or renal disease 2 • Narcotic idiosyncrasies 2 • Convulsive disorders 2 • Acute alcoholism 2 • Delirium tremens 2 • Premature labor 2 • Significant respiratory depression. (4) • Acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment.contraindicated

• Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals. (2.1) • Individualize dosing based on the severity of pain, patient response, and prior analgesic experience, and risk factor for addiction, abuse, and misuse. (2.1) • Initiate dosing with one suppository once or twice daily as needed for pain. (2.2) • Do not stop belladonna and opium suppositories abruptly in a physically dependent patient. (2.4) 2.1 Important Dosage and Administration Instructions Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [ see Warnings and Precautions (5) ]. Initiate the dosing regimen for each patient individually, taking into account the patient's severity of pain, patient response, prior analgesic treatment experience, and risk factors for addiction, abuse, and misuse [ see Warnings and Precautions (5.1) ]. Monitor patients closely for respiratory depression, especially within the first 24-72 hours of initiating therapy and following dosage increases with belladonna and opium suppositories and adjust the dosage accordingly [ see Warnings and Precautions (5.2) ]. 2.2 Dosing One belladonna and opium suppository rectally once or twice daily, not to exceed four doses daily or as recommended by the physician. Moisten finger and suppository with water before inserting. Absorption is dependent on body hydration and not on body temperature. Not recommended for use in children 12 years of age and under.

These preparations are not recommended for use in children. • Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients: Monitor closely, particularly during initiation and titration. (5.5) • Adrenal Insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid. (5.6) • Severe Hypotension: Monitor during dosage initiation and titration. Avoid use of Morphine Sulfate Oral Solution in patients with circulatory shock. (5.7) • Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury, or Impaired Consciousness: Monitor for sedation and respiratory depression. Avoid use of belladonna and opium suppositories in patients with impaired consciousness or coma. (5.8) 5.1 Addiction, Abuse, and Misuse Belladonna and opium suppositories contains opium, a Schedule II controlled substance. As an opioid, belladonna and opium suppositories exposes users to the risks of addiction, abuse, and misuse [ see Drug Abuse and Dependence (9) ]. Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed belladonna and opium suppositories. Addiction can occur at recommended dosages and if the drug is misused or abused. Assess each patient’s risk for opioid addiction, abuse, or misuse prior to prescribing belladonna and opium suppositories, and monitor all patients receiving belladonna and opium suppositories for the development of these behaviors or conditions.

Belladonna may cause drowsiness, dry mouth, urinary retention, photophobia, rapid pulse, dizziness and blurred vision 7 . Opium usage may result in constipation, nausea or vomiting. Pruritis and urticaria may occasionally occur. Hypersensitivity to opium or belladonna may occur. The following serious adverse reactions are described, or described in greater detail, in other sections: • Addiction, Abuse, and Misuse [ see Warnings and Precautions (5.1) ] • Life-Threatening Respiratory Depression [ see Warnings and Precautions (5.2) ] • Neonatal Opioid Withdrawal Syndrome [ see Warnings and Precautions (5.3) ] • Interactions with Benzodiazepines and Other CNS Depressants [ see Warnings and Precautions (5.4) ] • Adrenal Insufficiency [ see Warnings and Precautions (5.6) ] • Severe Hypotension [ see Warnings and Precautions (5.7) ] • Gastrointestinal Adverse Reactions [ see Warnings and Precautions (5.9) ] • Seizures [ see Warnings and Precautions (5.11) ] • Withdrawal [ see Warnings and Precautions (5.12) ] Most common adverse reactions are drowsiness, dry mouth, urinary retention, photophobia, rapid pulse, dizziness and blurred vision, constipation, nausea and vomiting. (6) To report SUSPECTED ADVERSE REACTIONS, contact Perrigo at 1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of opioids.

Pregnancy : May cause fetal harm. (8.1) Revised: 12/2017 8.1 Pregnancy Risk Summary Prolonged use of opioid analgesics during pregnancy may cause neonatal opioid withdrawal syndrome. There are no available data with belladonna and opium suppositories in pregnant women to inform a drug associated risk for major birth defects and miscarriage. Clinical Considerations Fetal/Neonatal Adverse Reactions Prolonged use of opioid analgesics during pregnancy for medical or nonmedical purposes can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth. Neonatal opioid withdrawal syndrome presents as irritability, hyperactivity and abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea and failure to gain weight. The onset, duration, and severity of neonatal opioid withdrawal syndrome vary based on the specific opioid used, duration of use, timing and amount of last maternal use, and rate of elimination of the drug by the newborn. Observe newborns for symptoms of neonatal opioid withdrawal syndrome and manage accordingly [ see Warnings and Precautions (5.3) ]. Belladonna refers to plant alkaloids that contain anticholinergic agents such as atropine. Atropine used in human pregnancies has not been associated with birth defects or adverse fetal effects although the drug readily crosses the placenta.

Metabolism

Upon absorption of morphine, oxidative dealkylation to produce nor-compounds appears to be the first step in the reaction sequence which imparts analgesia. Morphine is conjugated in the liver to form the 3-glucuronide which passes into the bile and is reabsorbed and excreted in the urine.

Clinical Presentation Acute overdose with belladonna and opium suppositories can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and, in some cases, pulmonary edema, bradycardia, hypotension, partial or complete airway obstruction, atypical snoring, and death. Marked mydriasis rather than miosis may be seen with hypoxia in overdose situations [ see Clinical Pharmacology (12) ]. Treatment of Overdose In case of overdose, priorities are the reestablishment of a patent and protected airway and institution of assisted or controlled ventilation, if needed. Employ other supportive measures (including oxygen and vasopressors) in the management of circulatory shock and pulmonary edema as indicated. Cardiac arrest or arrhythmias will require advanced life-support techniques. The opioid antagonists, naloxone or nalmefene, are specific antidotes to respiratory depression resulting from opioid overdose. For clinically significant respiratory or circulatory depression secondary to opium overdose, administer an opioid antagonist.

1. 1Urticaria433%
2. 2Drug Hypersensitivity325%
3. 3Pruritus325%
4. 4Abdominal Pain Lower217%
5. 5Anaemia217%
6. 6Anosmia217%
7. 7Asthenia217%
8. 8Blood Pressure Decreased217%
9. 9Chest Pain217%
10. 10Chronic Spontaneous Urticaria217%
11. 11Condition Aggravated217%
12. 12Covid-19217%
13. 13Death217%
14. 14Decreased Appetite217%
15. 15Diarrhoea217%

Recent PubMed references pinned to Opium as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• The association of smoking and opium consumption with the risk and prognosis of colorectal cancer: A multicenter retrospective cohort study.
  Medicine · 2026 · Rezazadeh M, Mansourian M, Kheradpishe A, et al.
  PMID 42071823DOI 10.1097/MD.0000000000048199
• Eradication and livelihoods: Household determinants of opium poppy cultivation in Eastern Afghanistan.
  The International journal on drug policy · 2026 · Shinwari AS, Herzfeld T
  PMID 41844073DOI 10.1016/j.drugpo.2026.105230
• The effect of opium consumption on prostate cancer among Iranian patients: A retrospective analytical study.
  Medicine · 2026 · Mohammadi R, Mirzaei M, Tajik Ghanbari A, et al.
  PMID 41824892DOI 10.1097/MD.0000000000047975
• The Association Between Opium Consumption, Diabetes, and Hypertension Among Male Participants in the Tabari Cohort Population: A Cross-sectional Study.
  Journal of research in health sciences · 2026 · Heydari K, Kheradmand M, Ahmadnezhad S, et al.
  PMID 41367071DOI 10.34172/jrhs.11343
• Beyond the ban: Explaining how Turkey reduced diversion and illicit poppy cultivation after 1974.
  The International journal on drug policy · 2025 · Turkkan C
  PMID 41207005DOI 10.1016/j.drugpo.2025.105053
• Opium use and oral cancer in Iran: A systematic review and meta-analysis.
  Medicine · 2025 · Keykha E, Shabanpour MJ, Tahmasebi E, et al.
  PMID 41029094DOI 10.1097/MD.0000000000044765
• Impact of smoking and opium cessation on gastrointestinal cancer risk: A 15-year longitudinal study in Golestan Cohort.
  Scientific reports · 2025 · Mansouri M, Sheidaei A, Poustchi H, et al.
  PMID 40596565DOI 10.1038/s41598-025-06783-3
• Associations between Opium Route of Use and Exposure to Polycyclic Aromatic Hydrocarbons as Potential Carcinogenicity Mechanism.
  Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology · 2025 · Naghash M, Calafat AM, Poustchi H, et al.
  PMID 40471020DOI 10.1158/1055-9965.EPI-25-0126

The 10 most recently updated of 21 ClinicalTrials.gov registrations naming Opium as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Opium Tincture Against Chronic Diarrhea - Patients
  Completed · Phase 2 · Interventional · 11 enrolled · Asbjørn Mohr Drewes
  NCT05690321updated 2024-04-22
• Delirium in Elderly Patients With Trauma of the Hip
  Terminated · Phase 4 · Interventional · 239 enrolled · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  NCT02689024updated 2023-08-04
• The Effect of IV PAPAVERINE 80 mg Prior to Catheter Balloon Insertion on Bishop Score and Pain
  Unknown · Interventional · 128 enrolled · Western Galilee Hospital-Nahariya
  NCT05759364updated 2023-06-29
• The Use of Belladonna and Opium Suppository in the Treatment of Postoperative Stent Pain
  Completed · Phase 4 · Interventional · 71 enrolled · University of Washington
  NCT03332056updated 2023-06-18
• Prospective Randomized Open Label Study of the Treatment of Therapy-associated Diarrhea During Percutaneous Radiation Therapy of the Small Pelvis. - Comparison of Loperamide and Tincture of Opium -
  Terminated · Phase 3 · Interventional · 1 enrolled · Philipps University Marburg
  NCT00444093updated 2023-05-11
• Bacteriostatic Normal Saline Versus Lidocaine for Intradermal Anesthesia
  Completed · Phase 4 · Interventional · 40 enrolled · Emory University
  NCT04495868updated 2023-04-18
• Opium Tincture Against Chronic Diarrhea - Healthy
  Completed · Interventional · 20 enrolled · Asbjørn Mohr Drewes
  NCT05702190updated 2023-01-30
• Personality and Drug Use
  Unknown · Observational · 1,000 enrolled · Psychedelic Data Society
  NCT05516823updated 2022-09-28
• Outcomes Mandate National Integration With Cannabis as Medicine
  Unknown · Phase 2 · Interventional · 200,000 enrolled · OMNI Medical Services, LLC
  NCT03944447updated 2022-06-02
• Personality and Drug Use (PDU)
  Withdrawn · Observational · 0 enrolled · Quantified Citizen Technologies Inc.
  NCT05180149updated 2022-04-29

Frequently asked questions

How does Opium work?

Belladonna/opium rectal suppository is a combination narcotic analgesic/antispasmodic agent. The belladonna extract component of the rectal suppository provides the active alkaloids atropine and scopolamine, while the opium component provides primarily morphine (among more than 20 alkaloids).

What is Opium used for?

According to FDA labeling, Opium carries indications including: Belladonna and opium suppositories are indicated for the management of ureteral spasm pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [ see Warnings and Precautions (5.1) ], reserve belladonna and opium suppositories for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: • Have not been tolerated, or are not expected to be tolerated, • Have not provided adequate analgesia, or are not expected to provide adequate analgesic Belladonna and opium suppositories are an opioid agonist indicated for the management of ureteral spasm pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Opium?

Opium is classified as Antipropulsives, Natural opium alkaloids, Opioid Agonists, Decreased GI Motility, Decreased Medullary Respiratory Drive, Decreased Peripheral Respiratory Drive, Digestive Alteration, Increased GI Smooth Muscle Tone.

What are the contraindications for Opium?

Opium labeling lists contraindications including: • Belladonna and opium suppositories are contraindicated in patients with: • Significant respiratory depression [ see Warnings and Precautions (5.2) ] • Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [ see Warnings and Precautions (5.5) ] • Concurrent use of monoamine oxidase inhibitors (MAOIs) or use of MAOIs within the last 14 days [ see Warnings and Precautions (5.7), Drug Interactions (7) ] • Known or suspected gastrointestinal obstruction, including paralytic ileus [ see Warnings and Precautions (5.9) ] • Hypersensitivity to opium or belladonna [ see Adverse Events (6) ] • Glaucoma 2 • Severe hepatic or renal disease 2 • Narcotic idiosyncrasies 2 • Convulsive disorders 2 • Acute alcoholism 2 • Delirium tremens 2 • Premature labor 2 • Significant respiratory depression. (4) • Acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment.. Always consult the full prescribing information and a clinician.