Hydromorphone — Membership Pricing

Other medications in Pain & Inflammation

• Ibuprofen
• Ketoprofen Gel
• Ketorolac
• Meclofenamate
• Menthol-Methyl Salicylate
• Meperidine
• Metaxalone
• Methadone

What Hydromorphone is approved for (FDA label)

Hydromorphone hydrochloride tablets are indicated for the management of 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, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions ( 5.2 )] , reserve opioid analgesics, including hydromorphone hydrochloride tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.

Source: Read the full FDA label on DailyMed. Label effective date: August 25, 2026.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Boxed warning for Hydromorphone (FDA label)

WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF HYDROMORPHONE HYDROCHLORIDE TABLETS WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF HYDROMORPHONE HYDROCHLORIDE TABLETS Addiction, Abuse, and Misuse Because the use of hydromorphone hydrochloride tablets expose patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death, assess each patient’s risk prior to prescribing and reassess all patients regularly for the development of these behaviors and conditions [see Warnings and Precautions ( 5.2 )]. Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of hydromorphone hydrochloride tablets, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of hydromorphone hydrochloride tablets are essential [see Warnings and Precautions ( 5.3 )]. Accidental Ingestion Accidental ingestion of even one dose of hydromorphone hydrochloride tablets, especially by children, can result in a fatal overdose of hydromorphone [see Warnings and Precautions ( 5.3 )]. Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death.

Source: FDA prescribing information (DailyMed). Set ID: 59d88866-e1ba-9d97-e063-6394a90a7b27. SPL document ID: 59d88829-80f2-2cac-e063-6294a90a9346. Label effective date: August 25, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Dosage forms and strengths for Hydromorphone (FDA label)

2 mg tablets (flat faced beveled or radius edge white to off-white tablet with one side debossed “M”; other side debossed “2”) 4 mg tablets (flat faced beveled edge white to off-white tablet with one side debossed “M”; other side debossed “4”) 8 mg tablets (white to off-white arc triangle shaped tablet debossed with a bisected “M” on one side and a split “8” on the other side) Hydromorphone hydrochloride tablets: 2 mg, 4 mg, 8 mg ( 3 )

Source: FDA prescribing information (DailyMed). Set ID: 59d88866-e1ba-9d97-e063-6394a90a7b27. SPL document ID: 59d88829-80f2-2cac-e063-6294a90a9346. Label effective date: August 25, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Adverse reactions for Hydromorphone (FDA label)

The following serious adverse reactions are described, or described in greater detail, in other sections: Addiction, Abuse, and Misuse [see Warnings and Precautions ( 5.2 )] Life-Threatening Respiratory Depression [see Warnings and Precautions ( 5.3 )] Interactions with Benzodiazepines or Other CNS Depressants [see Warnings and Precautions ( 5.4 )] Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions ( 5.5 )] Opioid-Induced Hyperalgesia and Allodynia [see Warnings and Precautions ( 5.7 )] Adrenal Insufficiency [see Warnings and Precautions ( 5.9 )] Severe Hypotension [see Warnings and Precautions ( 5.10 )] Gastrointestinal Adverse Reactions [see Warnings and Precautions ( 5.12 )] Seizures [see Warnings and Precautions ( 5.13 )] Withdrawal [see Warnings and Precautions ( 5.14 )] Most common adverse reactions are lightheadedness, dizziness, sedation, nausea, vomiting, sweating, flushing, dysphoria, euphoria, dry mouth, and pruritus. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Mallinckrodt at 1-800-778-7898 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Source: FDA prescribing information (DailyMed). Set ID: 59d88866-e1ba-9d97-e063-6394a90a7b27. SPL document ID: 59d88829-80f2-2cac-e063-6294a90a9346. Label effective date: August 25, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Contraindications for Hydromorphone (FDA label)

Hydromorphone hydrochloride tablets are contraindicated in patients with: Significant respiratory depression [see Warnings and Precautions ( 5.3 )] Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see Warnings and Precautions ( 5.8 )] Known or suspected gastrointestinal obstruction, including paralytic ileus [see Warnings and Precautions ( 5.12 )] Hypersensitivity to hydromorphone, hydromorphone salts, any other components of the product, or sulfite-containing medications (e.g., anaphylaxis) [see Warnings and Precautions ( 5.16 ), Adverse Reactions ( 6.1 )] Significant respiratory depression. ( 4 ) Acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment. ( 4 ) Known or suspected gastrointestinal obstruction, including paralytic ileus. ( 4 ) Known hypersensitivity to hydromorphone, hydromorphone salts, or sulfite-containing medications. ( 4 )

Source: FDA prescribing information (DailyMed). Set ID: 59d88866-e1ba-9d97-e063-6394a90a7b27. SPL document ID: 59d88829-80f2-2cac-e063-6294a90a9346. Label effective date: August 25, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Warnings and precautions for Hydromorphone (FDA label)

Opioid-Induced Hyperalgesia and Allodynia: Opioid-Induced Hyperalgesia (OIH) occurs when an opioid analgesic paradoxically causes an increase in pain, or an increase in sensitivity to pain. If OIH is suspected, carefully consider appropriately decreasing the dose of the current opioid analgesic or opioid rotation. ( 5.7 ) Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients: Regularly evaluate patients, particularly during initiation and titration. ( 5.8 ) Adrenal Insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid. ( 5.9 ) Severe Hypotension: Regularly evaluate patients during dosage initiation and titration. Avoid use of hydromorphone hydrochloride tablets in patients with circulatory shock. ( 5.10 ) Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury, or Impaired Consciousness: Monitor patients for sedation and respiratory depression.

Source: FDA prescribing information (DailyMed). Set ID: 59d88866-e1ba-9d97-e063-6394a90a7b27. SPL document ID: 59d88829-80f2-2cac-e063-6294a90a9346. Label effective date: August 25, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Drug interactions for Hydromorphone (FDA label)

Table 1 includes clinically significant drug interactions with hydromorphone hydrochloride tablets. Table 1: Clinically Significant Drug Interactions with Hydromorphone Hydrochloride Tablets Benzodiazepines and Other Central Nervous System (CNS) Depressants Clinical Impact: Due to additive pharmacologic effect, the concomitant use of benzodiazepines or other CNS depressants, including alcohol, can increase the risk of hypotension, respiratory depression, profound sedation, coma, and death [see Warnings and Precautions ( 5.4 )] . Intervention: Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Inform patients and caregivers of this potential interaction and educate them on the signs and symptoms of respiratory depression (including sedation).

Source: FDA prescribing information (DailyMed). Set ID: 59d88866-e1ba-9d97-e063-6394a90a7b27. SPL document ID: 59d88829-80f2-2cac-e063-6294a90a9346. Label effective date: August 25, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.