Opium is an active pharmaceutical ingredient in the Antipropulsives group (A07DA). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
USOfficial regulatory label· revised January 11, 2024[1]
1 INDICATIONS AND USAGE 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. , 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.
, 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 analgesia
GBUnited Kingdom· MHRA
1 product
Uses
GBOfficial regulatory label· revised January 9, 2026[2]
Symptomatic treatment of severe diarrhoea in adults, when use of other anti- diarrhoea treatments have not given sufficient effect.
How to take
GB
Drug interactions
Known interactions involving Opium. Select one for details. This list is informational and not a complete interaction checker.
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Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
[1]FDA DailyMed · 088b9cd1-da68-4c… · revised January 11, 2024 [PDF]
[2]MHRA (UK) · PL412840003 · revised January 9, 2026
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.
How to take
USOfficial regulatory label· revised January 11, 2024[1]
2 DOSAGE AND ADMINISTRATION • Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals. 1) • Individualize dosing based on the severity of pain, patient response, and prior analgesic experience, and risk factor for addiction, abuse, and misuse.
1) • Initiate dosing with one suppository once or twice daily as needed for pain. 2) • Do not stop belladonna and opium suppositories abruptly in a physically dependent patient. 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) ].
1) ]. 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. Conversion from Other Opioids to Belladonna and Opium Suppositories There is inter-patient variability in the potency of opioid drugs and opioid formulations. Therefore, a conservative approach is advised when determining the total daily dosage of belladonna and opium suppositories.
It is safer to underestimate a patient’s 24-hour belladonna and opium suppositories dosage than to overestimate the 24-hour belladonna and opium suppositories dosage and manage an adverse reaction due to overdose. Conversion from Belladonna and Opium suppositories to Extended-Release Opioid The relative bioavailability of belladonna and opium suppositories compared to extended-release opioid is unknown, so conversion to extended-release drug product must be accompanied by close observation for signs of excessive sedation and respiratory depression.
1) ]. Frequent communication is important among the prescriber, other members of the healthcare team, the patient, and the caregiver/family during periods of changing analgesic requirements, including initial titration. If the level of pain increases after dosage stabilization, attempt to identify the source of increased pain before increasing the belladonna and opium suppositories dosage.
If unacceptable opioid-related adverse reactions are observed, consider reducing the dosage. Adjust the dosage to obtain an appropriate balance between management of pain and opioid-related adverse reactions. 4 Discontinuation of Belladonna and Opium Suppositories When a patient who has been taking belladonna and opium suppositories regularly and may be physically dependent no longer requires therapy with belladonna and opium suppositories, use a gradual downward titration of the dosage to prevent signs and symptoms of withdrawal.
3) ].
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
USOfficial regulatory label· Adverse reactions· revised January 11, 2024[1]
6 ADVERSE REACTIONS 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. 12) ] Most common adverse reactions are drowsiness, dry mouth, urinary retention, photophobia, rapid pulse, dizziness and blurred vision, constipation, nausea and vomiting. gov/medwatch.
2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of opioids. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Serotonin syndrome:
Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs.
Adrenal insufficiency:
Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use.
Anaphylaxis:
Anaphylaxis has been reported with products containing opioids.
Androgen deficiency:
Cases of androgen deficiency have occurred with chronic use of opioids
USOfficial regulatory label· Warnings and precautions· revised January 11, 2024[1]
5 WARNINGS AND PRECAUTIONS 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) • Adrenal Insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid. 6) • Severe Hypotension: Monitor during dosage initiation and titration. Avoid use of Morphine Sulfate Oral Solution in patients with circulatory shock.
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.
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.
, major depression). The potential for these risks should not, however, prevent the proper management of pain in any given patient. Patients at increased risk may be prescribed opioids such as belladonna and opium suppositories, but use in such patients necessitates intensive counseling about the risks and proper use of belladonna and opium suppositories along with intensive monitoring for signs of addiction, abuse, and misuse.
Opioids are sought by drug abusers and people with addiction disorders and are subject to criminal diversion. Consider these risks when prescribing or dispensing belladonna and opium suppositories. Strategies to reduce these risks include prescribing the drug in the smallest appropriate quantity and advising the patient on the proper disposal of unused drug [ see Patient Counseling Information (17) ].
Contact local state professional licensing board or state controlled substances authority for information on how to prevent and detect abuse or diversion of this product. 2 Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression has been reported with the use of opioids, even when used as recommended.
Respiratory depression, if not immediately recognized and treated, may lead to respiratory arrest and death. Management of respiratory depression may include close observation, supportive measures, and use of opioid antagonists, depending on the patient’s clinical status [ see Overdosage (10) ].
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
USOfficial regulatory label· Contraindications· revised January 11, 2024[1]
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. (4) • Concurrent use of monoamine oxidase inhibitors (MAOIs) or use of MAOIs within the last 14 days (4) • Known or suspected gastrointestinal obstruction, including paralytic ileus.
(4) • Hypersensitivity to opium or belladonna. (4)
This is not medical advice. Consult a qualified healthcare professional.
Posology Usual starting dose in adults: 5–10 drops, 2–3 times daily. 4). 1. e. oncologist or gastroenterologist. Particular caution should be exercised when prescribing this drug due to its morphine content. The treatment period should be as short as possible.
Elderly Caution should be exercised and the dosage initially reduced in treatment of elderly subjects. Hepatic impairment Morphine may precipitate coma in hepatic impairment – avoid or reduce dose. 3 and
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
GBOfficial regulatory label· Adverse reactions· revised January 9, 2026[2]
The adverse events reported for Dropizol drops are derived from literature and post- marketing experience with other morphine products. Endocrine disorders Very rare /<1/10,000) Syndrome of inadequate ADH-secretion (SIADH), Amenorrhoea Not known (cannot be estimated from the available data) Adrenal insufficiency Psychiatric disorders Not known (cannot be estimated from the available data) Addiction, dysphoric mood, restlessness, decreased libido or potency, hallucinations.
Nervous system disorders Very common (1/10) Common (1/100 to <1/10) Very rare (<1/10,000) Not known (cannot be estimated from the available data) Drowsiness Dizziness, headache Muscle cramps, seizures, allodynia and hyperalgesia Euphoria Eye disorders Common (1/100 to <1/10) Very rare (<1/10,000) Miosis Blurred vision, diplopia, nystagmus Cardiac disorders Uncommon (1/1,000 to <1/100) Tachycardia, bradycardia, palpitations, facial flushing Vascular disorders Rare (1/10,000 to <1/1,000) Orthostatic hypotension Respiratory, thoracic and mediastinal disorders Common (1/100 to <1/10) Uncommon (1/1,000 to <1/100) Very rare /<1/10,000) Not known (cannot be estimated from the available data) Bronchospasms, cough decreased Respiratory depression Dyspnoea Central sleep apnoea syndrome Gastrointestinal disorders Very common (1/10) Common (1/100 to <1/10) Rare (≥1/10,000 to <1/1,000) Very rare /<1/10,000) Not known (cannot be estimated from the available data) Constipation, dry mouth Nausea, vomiting, loss of appetite, dyspepsia, dysgeusia Pancreatic enzymes increase and pancreatitis Ileus, abdominal pain Pancreatitis Hepatobiliary disorder Uncommon (1/1,000 to <1/100) Rare (1/10,000 to <1/1,000) Hepatic enzymes increased Biliary colic Not known (cannot be estimated from the available data) Spasm of sphincter of Oddi Skin and subcutaneous tissue disorders Common (1/100 to <1/10) Uncommon (1/1,000 to <1/100) Very rare /<1/10,000) Not known (cannot be estimated from the available data) Urticaria, sweating Pruritus Exanthema, peripheral oedema Acute generalised exanthematous pustulosis (AGEP) Musculoskeletal and connective tissue disorders Not known (cannot be estimated from the available data) Involuntary muscle contractions Renal and urinary disorders Common (1/100 to <1/10) Uncommon (1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000) Urinary retention Urethral spasm Renal colic General disorders and administration site conditions Common (1/100 to <1/10) Rare (1/10,000 to <1/1,000) Very rare /<1/10,000) Not known (cannot be estimated from the available data) Asthenia Withdrawal symptoms Feeling unwell, shivering Hyperthermia, vertigo Description of selected adverse reactions Drug Dependence Repeated use of Dropizol can lead to drug dependence, even at therapeutic doses.
4). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V
GBOfficial regulatory label· Warnings and precautions· revised January 9, 2026[2]
4. Renal impairment Elimination is reduced and delayed in renal impairment - avoid or reduce dose. 4. Method of administration Oral use. The product can be used undiluted or mixed in a glass of water. After mixture with water, it should be used immediately.
If the product is used undiluted the correct dosage can be administered with a spoon. 1. • Opiate dependency. • Glaucoma. • Severe hepatic or renal impairment. • Delirium tremens. • Severe head trauma. • Risk of paralytic ileus. 4 Special warnings and precautions for use Dropizol should only be used following investigations of the etiology causing the symptoms and when first-line treatment has not given adequate results.
Dropizol drops should be used with caution in the following conditions / for the following patients: • The elderly • Chronic renal disease and/or hepatic disease. • Alcoholism. 5. • Convulsive disorders • Gastrointestinal haemorrhage A health care professional should be contacted in case of difficulty to urinate.
3). Avoid use in older adults with a history of falls or fractures as ataxia, impaired psychomotor function, syncope, and additional falls may occur. If use is necessary, consider reducing use of other CNS-active agents that increase risk of falls and fractures and implement other strategies to reduce risk of falls.
Anti-diarrheals inhibiting peristalsis should be used with caution in patients with infection or inflammatory bowel diseases due to the increased risk of absorption of toxins, and of developing toxic megacolon and intestinal perforation.
Due to the risk of paralytic ileus, Dropizol is not recommended before a surgical operation or within 24 hours after operation. If paralytic ileus is suspected during the use of Dropizol, the treatment must be stopped immediately. Repeated administration may cause dependence and tolerance and the use of opium may lead to addiction to the substance.
Particular caution should be exercised in individuals predisposed to addiction to narcotics and alcohol. Risk from concomitant use of sedative medicines such as benzodiazepines or related drugs Concomitant use of Dropizol and sedative medicines such as benzodiazepines or related drugs may result in sedation, respiratory depression, coma and death.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
GBOfficial regulatory label· Contraindications· revised January 9, 2026[2]
1. • Opiate dependency. • Glaucoma. • Severe hepatic or renal impairment. • Delirium tremens. • Severe head trauma. • Risk of paralytic ileus. 6
This is not medical advice. Consult a qualified healthcare professional.
Carbon dioxide (CO 2 ) retention from opioid-induced respiratory depression can exacerbate the sedating effects of opioids. While serious, life-threatening, or fatal respiratory depression can occur at any time during the use of belladonna and opium suppositories, the risk is greatest during the initiation of therapy or following a dosage increase.
Monitor patients closely for respiratory depression, especially within the first 24-72 hours of initiating therapy with and following dosage increases of belladonna and opium suppositories. 2) ]. Overestimating the belladonna and opium suppositories dosage when converting patients from another opioid product can result in a fatal overdose with the first dose.
Accidental exposure of even one dose of belladonna and opium suppositories, especially by children, can result in respiratory depression and death due to an overdose of opium. 3 Neonatal Opioid Withdrawal Syndrome Prolonged use of belladonna and opium suppositories during pregnancy can result in withdrawal in the neonate.
Neonatal opioid withdrawal syndrome, unlike opioid withdrawal syndrome in adults, may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. 1), Patient Counseling Information ].
, non-benzodiazepine sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, other opioids, alcohol). Because of these risks, reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate.
Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug-related mortality compared to use of opioid analgesics alone. Because of similar pharmacological properties, it is reasonable to expect similar risk with the concomitant use of other CNS depressant drugs with opioid analgesics [ see Drug Interactions (7) ].
If the decision is made to prescribe a benzodiazepine or other CNS depressant concomitantly with an opioid analgesic, prescribe the lowest effective dosages and minimum durations of concomitant use. In patients already receiving an opioid analgesic, prescribe a lower initial dose of the benzodiazepine or other CNS depressant than indicated in the absence of an opioid, and titrate based on clinical response.
If an opioid analgesic is initiated in a patient already taking a benzodiazepine or other CNS depressant, prescribe a lower initial dose of the opioid analgesic, and titrate based on clinical response. Follow patients closely for signs and symptoms of respiratory depression and sedation.
Advise both patients and caregivers about the risks of respiratory depression and sedation when belladonna and opium suppositories are used with benzodiazepines or other CNS depressants (including alcohol and illicit drugs). Advise patients not to drive or operate heavy machinery until the effects of concomitant use of the benzodiazepine or other CNS depressant have been determined.
Screen patients for risk of substance use disorders, including opioid abuse and misuse, and warn them of the risk for overdose and death associated with the use of additional CNS depressants including alcohol and illicit drugs [ see Drug Interactions (7) and Patient Counseling Information (17) ].
5 Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients The use of belladonna and opium suppositories in patients with acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment is contraindicated.
2) ]. 2) ]. 2) ]. Alternatively, consider the use of non-opioid analgesics in these patients. 6 Interactions with Monoamine Oxidase Inhibitors Monoamine oxidase inhibitors (MAOIs) may potentiate the effects of opioids, including respiratory depression, coma, and confusion.
Belladonna and Opium Suppositories should not be used in patients taking MAOIs or within 14 days of stopping such treatment. 7 Adrenal Insufficiency Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use.
Presentation of adrenal insufficiency may include non-specific symptoms and signs including nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure. If adrenal insufficiency is suspected, confirm the diagnosis with diagnostic testing as soon as possible.
If adrenal insufficiency is diagnosed, treat with physiologic replacement doses of corticosteroids. Wean the patient off of the opioid to allow adrenal function to recover and continue corticosteroid treatment until adrenal function recovers.
Other opioids may be tried as some cases reported use of a different opioid without recurrence of adrenal insufficiency. The information available does not identify any particular opioids as being more likely to be associated with adrenal insufficiency.
8 Severe Hypotension Belladonna and opium suppositories may cause severe hypotension including orthostatic hypotension and syncope in ambulatory patients. , phenothiazines or general anesthetics) [ see Drug Interactions (7) ]. Monitor these patients for signs of hypotension after initiating or titrating the dosage of belladonna and opium suppositories.
In patients with circulatory shock, belladonna and opium suppositories may cause vasodilation that can further reduce cardiac output and blood pressure. Avoid the use of belladonna and opium suppositories in patients with circulatory shock.
, those with evidence of increased intracranial pressure or brain tumors), belladonna and opium suppositories may reduce respiratory drive, and the resultant CO 2 retention can further increase intracranial pressure. Monitor such patients for signs of sedation and respiratory depression, particularly when initiating therapy with belladonna and opium suppositories.
Opioids may also obscure the clinical course in a patient with a head injury. Avoid the use of belladonna and opium suppositories in patients with impaired consciousness or coma. 10 Risks of Use in Patients with Gastrointestinal Conditions Belladonna and opium suppositories are contraindicated in patients with known or suspected gastrointestinal obstruction, including paralytic ileus.
The opium in belladonna and opium suppositories may cause spasm of the sphincter of Oddi. Opioids may cause increases in serum amylase. Monitor patients with biliary tract disease, including acute pancreatitis, for worsening symptoms.
11 Increased Risk of Seizures in Patients with Seizure Disorders The opium in belladonna and opium suppositories may increase the frequency of seizures in patients with seizure disorders, and may increase the risk of seizures occurring in other clinical settings associated with seizures.
Monitor patients with a history of seizure disorders for worsened seizure control during belladonna and opium suppositories therapy. , buprenorphine) analgesics in patients who are receiving a full opioid agonist analgesic, including belladonna and opium suppositories.
In these patients, mixed agonist/antagonist and partial agonist analgesics may reduce the analgesic effect and/or precipitate withdrawal symptoms [ see Drug Interactions (7) ]. 4) ]. 3) ]. 13 Risks of Driving and Operating Machinery Belladonna and opium suppositories may impair the mental or physical abilities needed to perform potentially hazardous activities such as driving a car or operating machinery.
Warn patients not to drive or operate dangerous machinery unless they are tolerant to the effects of belladonna and opium suppositories and know how they will react to the medication [see Patient Counseling Information (17)].
Because of these risks, concomitant prescribing with these sedative medicines should be reserved for patients for whom alternative treatment options are not possible. If a decision is made to prescribe Dropizol concomitantly with sedative medicines, the lowest effective dose should be used, and the duration of treatment should be as short as possible.
The patients should be followed closely for signs and symptoms of respiratory depression and sedation. 5). 2). 5). Sleep related breathing disorders. Opioids can cause sleep-related breathing disorders including central sleep apnoea (CSA) and sleep-related hypoxemia.
Opioid use increases the risk of CSA in a dose- dependent fashion. In patients who present with CSA, consider decreasing the total opioid dosage. Severe cutaneous adverse reactions (SCARs) Acute generalized exanthematous pustulosis (AGEP), which can be life-threatening or fatal, has been reported in association with morphine treatment.
Most of these reactions occurred within the first 10 days of treatment. Patients should be informed about the signs and symptoms of AGEP and advised to seek medical care if they experience such symptoms. If signs and symptoms suggestive of these skin reactions appear, morphine should be withdrawn and an alternative treatment considered.
Hepatobiliary disorders Morphine may cause dysfunction and spasm of the sphincter of Oddi, thus raising intrabiliary pressure and increasing the risk of biliary tract symptoms and pancreatitis. Opioid Use Disorder (abuse and dependence) Tolerance and physical and/or psychological dependence may develop upon repeated administration of opioids such as Dropizol.
Repeated use of Dropizol can lead to Opioid Use Disorder (OUD). A higher dose and longer duration of opioid treatment, can increase the risk of developing OUD. Abuse or intentional misuse of Dropizol may result in overdose and/or death.
The risk of developing OUD is increased in patients with a personal or a family history (parents or siblings) of substance use disorders (including alcohol use disorder), in current tobacco users or in patients with a personal […]