What the label lists and what reports show
Morphine side effects
Morphine's FDA label: “Most common adverse reactions (>10%): constipation, nausea, and sedation.” FAERS holds 120,591 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is drug dependence (32,874 reports).
- Generic listed
- In shortage
- Boxed warning
- DEA Schedule II
Check it at the source: the morphine FDA label on DailyMed (effective July 13, 2026, Bryant Ranch Prepack); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsMost common adverse reactions (>10%): constipation, nausea, and sedation.
A table the label prints in its adverse reactions section without a title; its column headings name the groups compared
This table is printed in the Morphine Sulfate label published by Upsher-Smith Laboratories, LLC of July 9, 2025; the label quoted above does not print one.
| Reaction | Percentage % |
|---|---|
| CENTRAL NERVOUS SYSTEM | 28 |
| Drowsiness | 9 |
| Dizziness | 6 |
| Anxiety | 5 |
| Confusion | 4 |
| Dry mouth | 3 |
| Tremor | 2 |
| GASTROINTESTINAL | 26 |
| Constipation | 9 |
| Nausea | 7 |
| Diarrhea | 3 |
| Anorexia | 3 |
| Abdominal pain | 3 |
| Vomiting | 2 |
| BODY AS A WHOLE | 16 |
| Pain | 3 |
| Disease progression | 3 |
| Chest pain | 2 |
| Diaphoresis | 2 |
| Fever | 2 |
| Asthenia | 2 |
| Accidental injury | 2 |
| RESPIRATORY | 3 |
| Dyspnea | 3 |
| SKIN & APPENDAGES | 3 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe 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 (5.3)] Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions (5.4)] Interactions with Benzodiazepine or Other CNS Depressants [see Warnings and Precautions (5.5)] 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 (>10%): constipation, nausea, and sedation. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc. at 1-800-818-4555 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 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 practice. …
Source: FDA drug label, ANDA078761 (Sun Pharm Inds Ltd), as published by Bryant Ranch Prepack, effective July 13, 2026 (SPL set 595243fe-a4b1-479a-99d6-a084a4181891), via openFDA; the full label on DailyMed
What do FAERS reports show?
120,591 reports list morphine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 34,831 are coded as a death and 22,989 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2018 (26,861, against a median of 4,938 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens. Of the 20 reactions below, 9 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Morphine: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions