This grade answers one narrow question: how strong is the public evidence and safety record behind this drug, and how clean is its money trail and court record? It is not a verdict on whether the drug is right for you.
WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF HYDROMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS Addiction, Abuse, and Misuse Because the use of hydromorphone hydrochloride extended-release tablets exposes 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 ( 5.1 )] . Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of hydromorphone hydrochloride extended-release tablets, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of hydromorphone hydrochloride extended-release tablets are essential. Instruct patients to swallow hydromorphone hydrochloride extended-release tablets whole to avoid exposure to a potentially fatal dose of hydromorphone [see Warnings and Precautions ( 5.2 )] . Accidental Ingestion Accidental ingestion of even one dose of hydromorphone hydrochloride extended-release tablets...
Listed on the WHO Model List of Essential Medicines: a global expert panel judged it among the medicines a health system should always have, on evidence of value, not marketing.
Hydromorphone hydrochloride extended-release tablets are indicated in opioid-tolerant patients for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Patients considered opioid tolerant are those who are receiving, for one week or longer, at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid. 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 ( 5.1 )] , reserve opioid analgesics, including hydromorphone hydrochloride extended-release 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. • Hydromorphone hydrochloride extended-release tablets are not indicated as an as-needed (prn) analgesic. Hydromor...
Hydromorphone hydrochloride extended-release tablets are contraindicated in: • Opioid non-tolerant patients. Fatal respiratory depression could occur in patients who are not opioid tolerant. • 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 ( 5.7 )] . • Known or suspected gastrointestinal obstruction, including paralytic ileus [see Warnings and Precautions ( 5.11 )] . • Patients who have had surgical procedures and/or underlying disease resulting in narrowing of the gastrointestinal tract, or have “blind loops” of the gastrointestinal tract or gastrointestinal obstruction [see Warnings and Precautions ( 5.11 )] . • Patients with hypersensitivity (e.g., anaphylaxis) to hydromorphone [see Warnings and Precautions ( 5.14 )]. • Opioid non-tolerant patients ( 4 ) • 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 ) • Narrowed or obstr...
• 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. ( 5.6 ) • Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or Elderly Cachectic Debilitated Patients : Regularly evaluate, particularly during initiation and titration. ( 5.7 ) • Adrenal Insufficiency : If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid. ( 5.8 ) • Severe Hypotension : Regularly evaluate during dose initiation and titration. Avoid use of hydromorphone hydrochloride extended-release tablets in patients with circulatory shock. ( 5.9 ) • 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 hydromorphone hydrochloride extended-release tablets in patients with impaired consciousness or coma. ( 5.10 ) 5.1 Addiction, Abuse, and Misuse Hydromorphone h...
The following serious adverse reactions are discussed elsewhere in the labeling: • 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 ( 5.4 )] • Interactions with Benzodiazepine or Other CNS Depressants [see Warnings and Precautions ( 5.3 )] • Opioid-Induced Hyperalgesia and Allodynia [see Warnings and Precautions ( 5.6 )] • Adrenal Insufficiency [see Warnings and Precautions ( 5.8 )] • Severe Hypotension [see Warnings and Precautions ( 5.9 )] • Gastrointestinal Adverse Reactions [see Warnings and Precautions ( 5.11 )] • Seizures [see Warnings and Precautions ( 5.12 )] • Withdrawal [see Warnings and Precautions ( 5.13 )] Most common adverse reactions (incidence >10%) are: constipation, nausea, vomiting, somnolence, headache, and dizziness. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Padagis ® at 1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical t...
Boxed Warning 12/2025 Indications and Usage ( 1 ) 12/2025 Dosage and Administration ( 2.2 , 2.3 , 2.5 ) 12/2025 Warnings and Precautions ( 5.1 , 5.2 , 5.3 , 5.11 , 5.13 ) 12/2025
Source: FDA SPL label for hydromorphone hydrochloride (Padagis US LLC), effective 20251222. Full label on DailyMed.
These are counts of reports people filed, not rates of harm. Anyone can file one, and nobody checks whether the drug was the cause. Millions of doses are taken for every report sent, so the useful part is how this drug compares with the average across all drugs.
| 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 | 2026 |
|---|---|---|---|---|---|---|---|
| 5,919 | 14,266 | 22,354 | 18,875 | 4,687 | 4,630 | 4,070 | 1,731 |
13,105 reports blaming this drug for every million Medicare prescriptions filled, which is 4.7× the typical drug on this site. (10,365 reports in 2024–2026, against 790,921 Medicare fills in one year. This is the one number here that accounts for how many people take the drug.)
Source: the FDA's Adverse Event Reporting System (FAERS). Reports are voluntary and unverified. Drugs that are prescribed a lot, in the news, or in lawsuits attract more reports, so the percentages are compared with the whole database to correct for that partly, not fully.
| Date | Class | Firm | Reason |
|---|---|---|---|
| 02/2018 | Class I | Pfizer Inc. | Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty or cracked. |
| 02/2018 | Class I | Pfizer Inc. | Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty or cracked. |
| 08/2017 | Class II | Pfizer Inc. | Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process. |
| 07/2017 | Class II | HOSPIRA INC, LAKE FOREST | Presence of Particulate Matter: Silicone oil |
| 07/2017 | Class II | HOSPIRA INC, LAKE FOREST | Presence of Particulate Matter: Silicone oil |
| 07/2017 | Class II | HOSPIRA INC, LAKE FOREST | Presence of Particulate Matter: Silicone oil |
| 10/2014 | Class II | Hospira Inc. | Lack Of Assurance Of Sterility: Confirmed customer complaints of glass product container vials that may be broken or cracked. |
| 08/2012 | Class I | Hospira Inc. | Superpotent (Single Ingredient) Drug: The prefilled cartridge unit has been found to be overfilled and contain more than the 1 mL labeled fill volume. |
| 05/2012 | Class I | Hospira Inc. | Superpotent (Single Ingredient) Drug: Some of the prefilled cartridge units have been found to be overfilled and contain more than the 1 mL labeled fill volume. |
Class I = reasonable probability of serious harm. Class II = temporary or reversible harm. Class III = unlikely to harm. Most generic recalls are manufacturing or labeling defects for one lot, not a verdict on the molecule.
Counts measure how much evidence exists and how transparent it is, not how big the benefit is. For that, ask your prescriber: if 100 people like me took this, how many would get better because of it, and how many would be harmed? (Doctors call these the "number needed to treat" and "number needed to harm.") It differs by condition and is the number drug ads leave out. Sources: PubMed, ClinicalTrials.gov.
In 2024, drug companies reported $32,966 in payments to US physicians and hospitals tied to this drug across 12 transactions (Dilaudid $32,966).
No pending federal MDL names this drug or its brands.
Not named in any federal pharmaceutical settlement of $100M or more on record.
Sources: CMS Open Payments (Sunshine Act); Judicial Panel on Multidistrict Litigation pending docket list; DOJ settlements as tabulated on Wikipedia with links to the primary record. State-court and individual suits are not included.
| Product | Fills | $/fill |
|---|---|---|
| Hydromorphone HCl | 775,285 | $17 |
| Hydromorphone ER | 14,879 | $311 |
| Dilaudid | 757 | $463 |
Same ATC pharmacological class, graded ones first, best grade at the top. Being in the same class does not make them interchangeable for your condition; it makes them worth asking about.