Drug · FAERS side-effect profile with label screen
Morphine Sulfate side effects: what 120,577 FDA adverse event reports show
Brand names
Opium
openFDA label
Who reports
120,577 reports · 86% serious · 34,831 with death outcome · 53% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Opium tincture is useful for the treatment of diarrhea.
FDA label, Indications and Usage
What it is
Morphine is a morphinane alkaloid that is a highly potent opiate analgesic psychoactive drug. Morphine acts directly on the central nervous system (CNS) to relieve pain but has a high potential for addiction, with tolerance and both physical and psychological dependence developing rapidly.
PubChem CID 5288826 (ChEBI)
Boxed warning
None in the current label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation.
Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)?
That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.
Causality screen of the 40 strongest signals
Reporting / coding artifact 8Lab value / disease marker 3No label text to screen 29
What the badges mean
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
- No label text to screen No validated FDA label was retrievable for this product, so the screen could not run. Disproportionality only.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only (and, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 1,172 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Vaginal flatulence | 142 | 151.4 120.8–189.8ROR 151.6 · calibrated p 6e-9 ✓ | 79.8 EB05 69.4 · IC025 +5.7 3/3 methods agree vs other Opioid Agonists: PRR 1.5 (1.2–1.9) | No label text to screen label has no adverse-reaction text | serious n=142 · ♀ 100% (drug 53%) | no trial arm names this drug |
| Learning disability | 1,171 | 48.1 45.1–51.3ROR 48.6 · calibrated p 2e-5 ✓ | 37.7 EB05 35.9 · IC025 +5.1 3/3 methods agree vs other Opioid Agonists: PRR 8.6 (7.7–9.6) | No label text to screen label has no adverse-reaction text | serious n=1,170 · 100% consumer | no trial arm names this drug |
| Sedation complication | 530 | 46.7 42.4–51.4ROR 46.9 · calibrated p 2e-5 ✓ | 36.8 EB05 34.3 · IC025 +5.0 3/3 methods agree vs other Opioid Agonists: PRR 5.6 (4.8–6.4) | Reporting / coding artifact | serious n=523 · ♀ 95% (drug 53%) | no trial arm names this drug |
| Drug dependence | 32,874 | 43.9 43.5–44.4ROR 60.0 · calibrated p 4e-6 ✓ | 35.1 EB05 34.8 · IC025 +5.1 3/3 methods agree vs other Opioid Agonists: PRR 12.4 (12.2–12.7) | Reporting / coding artifact | age-adj. PRR 16.6 · serious PRR 24.1 · 94% consumer | no trial arm names this drug |
| Anti-cyclic citrullinated peptide antibody | 129 | 41.5 34.3–50.3ROR 41.6 · calibrated p 5e-5 ✓ | 33.4 EB05 28.9 · IC025 +4.6 3/3 methods agree vs other Opioid Agonists: PRR 2.8 (2.2–3.5) | Lab value / disease marker | serious n=129 · ♀ 100% (drug 53%) · 100% clinician | no trial arm names this drug |
| Neurologic neglect syndrome | 107 | 40.9 33.1–50.5ROR 41.0 · calibrated p 5e-5 ✓ | 33.0 EB05 28.1 · IC025 +4.5 3/3 methods agree vs other Opioid Agonists: PRR 3.0 (2.3–4.0) | No label text to screen label has no adverse-reaction text | serious n=107 · ♀ 100% (drug 53%) · 100% clinician | no trial arm names this drug |
| Lupus vulgaris | 225 | 40.4 34.9–46.7ROR 40.5 · calibrated p 5e-5 ✓ | 32.8 EB05 29.3 · IC025 +4.7 3/3 methods agree vs other Opioid Agonists: PRR 3.2 (2.6–3.8) | No label text to screen label has no adverse-reaction text | serious n=225 · ♀ 100% (drug 53%) · 100% clinician | no trial arm names this drug |
| Vision abnormal neonatal | 79 | 39.8 31.1–50.8ROR 39.8 · calibrated p 7e-5 ✓ | 32.2 EB05 26.7 · IC025 +4.4 3/3 methods agree vs other Opioid Agonists: only this drug | No label text to screen label has no adverse-reaction text | serious n=79 · 100% consumer | no trial arm names this drug |
| Retinitis | 304 | 38.6 34.1–43.7ROR 38.7 · calibrated p 7e-5 ✓ | 31.6 EB05 28.7 · IC025 +4.7 3/3 methods agree vs other Opioid Agonists: PRR 4.8 (4.0–5.7) | No label text to screen label has no adverse-reaction text | serious n=304 · ♀ 100% (drug 53%) · 100% clinician | no trial arm names this drug |
| Drug withdrawal syndrome neonatal | 2,602 | 36.5 35.0–38.1ROR 37.3 · calibrated p 8e-5 ✓ | 30.2 EB05 29.3 · IC025 +4.8 3/3 methods agree vs other Opioid Agonists: PRR 8.0 (7.4–8.6) | No label text to screen label has no adverse-reaction text | serious PRR 20.4 · 98% consumer | no trial arm names this drug |
| Substance dependence | 113 | 35.2 28.7–43.1ROR 35.2 · calibrated p 1e-4 ✓ | 29.2 EB05 25.0 · IC025 +4.4 3/3 methods agree vs other Opioid Agonists: PRR 7.2 (5.1–10.1) | No label text to screen label has no adverse-reaction text | serious n=113 · 100% consumer | no trial arm names this drug |
| Polysubstance abuse | 106 | 34.1 27.7–42.0ROR 34.1 · calibrated p 2e-4 ✓ | 28.5 EB05 24.2 · IC025 +4.3 3/3 methods agree vs other Opioid Agonists: only this drug | Reporting / coding artifact | serious n=106 | no trial arm names this drug |
| Multiple drug overdose accidental | 74 | 32.9 25.6–42.2ROR 32.9 · calibrated p 2e-4 ✓ | 27.6 EB05 22.7 · IC025 +4.2 3/3 methods agree vs other Opioid Agonists: only this drug | No label text to screen label has no adverse-reaction text | serious n=74 · ♀ 0% (drug 53%) · 100% clinician | no trial arm names this drug |
| Drug withdrawal syndrome | 13,752 | 31.8 31.3–32.4ROR 35.8 · calibrated p 1e-4 ✓ | 27.0 EB05 26.6 · IC025 +4.7 3/3 methods agree vs other Opioid Agonists: PRR 9.8 (9.5–10.1) | No label text to screen label has no adverse-reaction text | age-adj. PRR 5.8 · serious PRR 22.6 · 84% consumer | no trial arm names this drug |
| Emotional distress | 16,962 | 28.1 27.7–28.5ROR 32.5 · calibrated p 2e-4 ✓ | 24.3 EB05 24.0 · IC025 +4.6 3/3 methods agree vs other Opioid Agonists: PRR 13.1 (12.7–13.5) | No label text to screen label has no adverse-reaction text | age-adj. PRR 2.3 · serious PRR 18.1 · 93% consumer | no trial arm names this drug |
| Carotid artery thrombosis | 108 | 25.1 20.5–30.7ROR 25.1 · calibrated p 7e-4 ✓ | 21.9 EB05 18.7 · IC025 +4.0 3/3 methods agree vs other Opioid Agonists: PRR 3.1 (2.3–4.0) | No label text to screen label has no adverse-reaction text | serious n=108 · ♀ 100% (drug 53%) · 100% clinician | no trial arm names this drug |
| Bronchopulmonary aspergillosis allergic | 115 | 24.8 20.4–30.2ROR 24.9 · calibrated p 8e-4 ✓ | 21.7 EB05 18.6 · IC025 +4.0 3/3 methods agree vs other Opioid Agonists: only this drug | No label text to screen label has no adverse-reaction text | serious n=115 · ♀ 78% (drug 53%) | no trial arm names this drug |
| Developmental delay | 1,141 | 24.8 23.3–26.4ROR 25.1 · calibrated p 7e-4 ✓ | 21.8 EB05 20.8 · IC025 +4.3 3/3 methods agree vs other Opioid Agonists: PRR 6.6 (5.9–7.3) | No label text to screen label has no adverse-reaction text | serious PRR 14.8 · 100% consumer | no trial arm names this drug |
| Creatinine renal clearance decreased | 501 | 24.6 22.4–27.0ROR 24.7 · calibrated p 7e-4 ✓ | 21.6 EB05 20.1 · IC025 +4.3 3/3 methods agree vs other Opioid Agonists: PRR 20.9 (16.3–26.7) | Lab value / disease marker | serious n=500 · ♀ 100% (drug 53%) | no trial arm names this drug |
| Self esteem decreased | 303 | 24.6 21.8–27.7ROR 24.6 · calibrated p 8e-4 ✓ | 21.6 EB05 19.6 · IC025 +4.2 3/3 methods agree vs other Opioid Agonists: only this drug | No label text to screen label has no adverse-reaction text | serious n=302 · 100% consumer | no trial arm names this drug |
| Seronegative arthritis | 132 | 23.1 19.2–27.7ROR 23.1 · calibrated p 0.001 ✓ | 20.4 EB05 17.6 · IC025 +4.0 3/3 methods agree vs other Opioid Agonists: PRR 2.8 (2.2–3.6) | No label text to screen label has no adverse-reaction text | serious n=132 · ♀ 100% (drug 53%) · 100% clinician | no trial arm names this drug |
| Acute chest syndrome | 98 | 21.8 17.7–26.9ROR 21.8 · calibrated p 0.001 ✓ | 19.4 EB05 16.4 · IC025 +3.8 3/3 methods agree vs other Opioid Agonists: only this drug | No label text to screen label has no adverse-reaction text | serious n=98 · 100% clinician | no trial arm names this drug |
| Temperature regulation disorder | 244 | 21.8 19.0–24.9ROR 21.8 · calibrated p 0.001 ✓ | 19.4 EB05 17.4 · IC025 +4.0 3/3 methods agree vs other Opioid Agonists: PRR 7.6 (6.0–9.7) | No label text to screen label has no adverse-reaction text | serious n=244 · ♀ 100% (drug 53%) | no trial arm names this drug |
| Overdose | 23,522 | 21.1 20.8–21.4ROR 26.0 · calibrated p 6e-4 ✓ | 18.9 EB05 18.7 · IC025 +4.2 3/3 methods agree vs other Opioid Agonists: PRR 6.6 (6.5–6.8) | Reporting / coding artifact | age-adj. PRR 6.0 · serious PRR 16.0 · 84% consumer | no trial arm names this drug |
| Multiple drug therapy | 73 | 20.2 15.9–25.8ROR 20.2 · calibrated p 0.002 ✓ | 18.1 EB05 14.9 · IC025 +3.6 3/3 methods agree vs other Opioid Agonists: only this drug | Reporting / coding artifact | serious n=73 · ♀ 100% (drug 53%) · 100% clinician | no trial arm names this drug |
| Female genital tract fistula | 167 | 18.6 15.9–21.8ROR 18.6 · calibrated p 0.003 ✓ | 16.8 EB05 14.8 · IC025 +3.8 3/3 methods agree vs other Opioid Agonists: PRR 1.5 (1.2–1.8) | No label text to screen label has no adverse-reaction text | serious n=166 · ♀ 100% (drug 53%) | no trial arm names this drug |
| Drug tolerance increased | 71 | 17.2 13.5–22.0ROR 17.2 · calibrated p 0.004 ✓ | 15.6 EB05 12.8 · IC025 +3.4 3/3 methods agree vs other Opioid Agonists: PRR 35.5 (15.4–81.7) | No label text to screen label has no adverse-reaction text | serious n=70 · ♀ 0% (drug 53%) · 100% consumer | no trial arm names this drug |
| Substance abuse | 735 | 17.1 15.9–18.5ROR 17.2 · calibrated p 0.004 ✓ | 15.7 EB05 14.7 · IC025 +3.8 3/3 methods agree vs other Opioid Agonists: PRR 3.1 (2.8–3.5) | Reporting / coding artifact | serious PRR 11.6 | no trial arm names this drug |
| Dependence | 5,003 | 17.1 16.6–17.6ROR 17.8 · calibrated p 0.003 ✓ | 15.7 EB05 15.3 · IC025 +3.9 3/3 methods agree vs other Opioid Agonists: PRR 3.2 (3.0–3.3) | No label text to screen label has no adverse-reaction text | serious PRR 10.6 · 100% consumer | no trial arm names this drug |
| Granuloma skin | 72 | 16.5 12.9–21.0ROR 16.5 · calibrated p 0.005 ✓ | 15.0 EB05 12.3 · IC025 +3.4 3/3 methods agree vs other Opioid Agonists: only this drug | No label text to screen label has no adverse-reaction text | serious n=72 · ♀ 100% (drug 53%) · 100% clinician | no trial arm names this drug |
| Drug diversion | 468 | 15.4 14.0–16.9ROR 15.5 · calibrated p 0.006 ✓ | 14.2 EB05 13.1 · IC025 +3.7 3/3 methods agree vs other Opioid Agonists: PRR 1.2 (1.1–1.3) | Reporting / coding artifact | serious n=363 · 83% consumer | no trial arm names this drug |
| Bone erosion | 287 | 15.3 13.5–17.2ROR 15.3 · calibrated p 0.007 ✓ | 14.1 EB05 12.7 · IC025 +3.6 3/3 methods agree vs other Opioid Agonists: PRR 3.4 (2.9–4.0) | No label text to screen label has no adverse-reaction text | serious n=287 · ♀ 100% (drug 53%) · 100% clinician | no trial arm names this drug |
| Adjustment disorder | 105 | 15.1 12.4–18.5ROR 15.2 · calibrated p 0.007 ✓ | 13.9 EB05 11.8 · IC025 +3.4 3/3 methods agree vs other Opioid Agonists: PRR 2.9 (2.2–3.7) | No label text to screen label has no adverse-reaction text | serious n=105 · ♀ 100% (drug 53%) · 100% clinician | no trial arm names this drug |
| Substance use disorder | 245 | 15.0 13.1–17.1ROR 15.0 · calibrated p 0.007 ✓ | 13.8 EB05 12.4 · IC025 +3.5 3/3 methods agree vs other Opioid Agonists: PRR 2.5 (2.1–2.9) | No label text to screen label has no adverse-reaction text | serious n=245 · 80% consumer | no trial arm names this drug |
| Learning disorder | 189 | 14.5 12.5–16.9ROR 14.6 · calibrated p 0.008 ✓ | 13.4 EB05 11.9 · IC025 +3.5 3/3 methods agree vs other Opioid Agonists: PRR 4.1 (3.3–5.1) | No label text to screen label has no adverse-reaction text | serious n=189 · 100% consumer | no trial arm names this drug |
| Toxicologic test abnormal | 47 | 14.4 10.7–19.4ROR 14.4 · calibrated p 0.010 ✓ | 13.1 EB05 10.1 · IC025 +3.1 3/3 methods agree vs other Opioid Agonists: PRR 10.8 (5.9–20.0) | Reporting / coding artifact | serious n=47 · 100% clinician | no trial arm names this drug |
| Creatinine renal clearance increased | 57 | 14.2 10.8–18.6ROR 14.2 · calibrated p 0.010 ✓ | 13.0 EB05 10.3 · IC025 +3.1 3/3 methods agree vs other Opioid Agonists: only this drug | Lab value / disease marker | serious n=57 · ♀ 100% (drug 53%) · 100% clinician | no trial arm names this drug |
| Multiple drug overdose | 377 | 14.0 12.6–15.6ROR 14.0 · calibrated p 0.009 ✓ | 13.0 EB05 11.9 · IC025 +3.5 3/3 methods agree vs other Opioid Agonists: PRR 4.7 (4.0–5.5) | No label text to screen label has no adverse-reaction text | serious n=377 · 95% clinician | no trial arm names this drug |
| Radiculopathy | 189 | 13.4 11.5–15.5ROR 13.4 · calibrated p 0.011 ✓ | 12.4 EB05 11.0 · IC025 +3.4 3/3 methods agree vs other Opioid Agonists: PRR 1.5 (1.2–1.8) | No label text to screen label has no adverse-reaction text | serious n=188 · ♀ 100% (drug 53%) | no trial arm names this drug |
| Toxicity to various agents | 11,801 | 13.1 12.9–13.3ROR 14.4 · calibrated p 0.008 ✓ | 12.2 EB05 12.0 · IC025 +3.6 3/3 methods agree vs other Opioid Agonists: PRR 3.0 (3.0–3.1) | No label text to screen label has no adverse-reaction text | age-adj. PRR 5.1 · serious PRR 8.4 | no trial arm names this drug |
Clinical concept groups
MedDRA splits one clinical problem across several terms (e.g. "neutropenia", "neutrophil count decreased", "agranulocytosis"), which dilutes term-level signals. These rows count reports with any term in a concept group (an exact union, not a sum), compared with all other drugs. Groups are hand-built and listed in the methods.
| Concept | Reports | PRR 95% CI | Reading |
|---|---|---|---|
| Dependence / withdrawal | 38,682 | 26.125.8–26.3 | signal |
| Depression | 3,364 | 2.12.0–2.2 | signal |
| Suicidality | 1,989 | 1.41.4–1.5 | raised |
| Interstitial lung disease | 693 | 1.31.2–1.4 | raised |
| Liver injury | 2,102 | 1.21.2–1.3 | raised |
| Fall / fracture | 2,446 | 1.11.1–1.2 | raised |
| Serious infection | 4,925 | 1.11.1–1.1 | raised |
| Hyponatraemia | 506 | 1.11.0–1.2 | raised |
| Anaphylaxis / angioedema | 770 | 1.11.0–1.1 | no difference |
| Anaemia | 1,837 | 1.11.0–1.1 | raised |
| Thrombocytopenia | 1,276 | 1.01.0–1.1 | no difference |
| Kidney injury | 2,431 | 0.90.9–1.0 | lower than other drugs |
| Venous thromboembolism | 1,137 | 0.90.9–1.0 | lower than other drugs |
| Gi bleeding | 928 | 0.90.8–0.9 | lower than other drugs |
| Rhabdomyolysis / myopathy | 402 | 0.90.8–0.9 | lower than other drugs |
| Osteonecrosis | 283 | 0.90.8–1.0 | lower than other drugs |
Trial evidence (ClinicalTrials.gov)
ClinicalTrials.gov returned results-bearing trials mentioning Morphine only as a background or rescue medication (NCT02625181, NCT04296396); no trial listing it as the tested intervention was cached, so no trial cross-check is shown.
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Drug dependence | 32,874 | 43.9 43.5–44.4ROR 60.0 · calibrated p 4e-6 ✓ | 35.1 EB05 34.8 · IC025 +5.1 3/3 methods agree vs other Opioid Agonists: PRR 12.4 (12.2–12.7) | Reporting / coding artifact | age-adj. PRR 16.6 · serious PRR 24.1 · 94% consumer | no trial arm names this drug |
| Overdose | 23,522 | 21.1 20.8–21.4ROR 26.0 · calibrated p 6e-4 ✓ | 18.9 EB05 18.7 · IC025 +4.2 3/3 methods agree vs other Opioid Agonists: PRR 6.6 (6.5–6.8) | Reporting / coding artifact | age-adj. PRR 6.0 · serious PRR 16.0 · 84% consumer | no trial arm names this drug |
| Pain | 21,679 | 6.3 6.2–6.4ROR 7.5 · calibrated p 0.081 | 6.1 EB05 6.1 · IC025 +2.6 3/3 methods agree vs other Opioid Agonists: PRR 4.7 (4.6–4.8) | No label text to screen label has no adverse-reaction text | age-adj. PRR 2.8 · serious PRR 6.3 | no trial arm names this drug |
| Death | 17,421 | 3.6 3.5–3.6ROR 4.0 · calibrated p 0.377 | 3.5 EB05 3.5 · IC025 +1.8 3/3 methods agree vs other Opioid Agonists: PRR 4.4 (4.3–4.5) | Outcome field, not a reaction | age-adj. PRR 1.7 · serious PRR 2.4 | no trial arm names this drug |
| Emotional distress | 16,962 | 28.1 27.7–28.5ROR 32.5 · calibrated p 2e-4 ✓ | 24.3 EB05 24.0 · IC025 +4.6 3/3 methods agree vs other Opioid Agonists: PRR 13.1 (12.7–13.5) | No label text to screen label has no adverse-reaction text | age-adj. PRR 2.3 · serious PRR 18.1 · 93% consumer | no trial arm names this drug |
| Drug withdrawal syndrome | 13,752 | 31.8 31.3–32.4ROR 35.8 · calibrated p 1e-4 ✓ | 27.0 EB05 26.6 · IC025 +4.7 3/3 methods agree vs other Opioid Agonists: PRR 9.8 (9.5–10.1) | No label text to screen label has no adverse-reaction text | age-adj. PRR 5.8 · serious PRR 22.6 · 84% consumer | no trial arm names this drug |
| Toxicity to various agents | 11,801 | 13.1 12.9–13.3ROR 14.4 · calibrated p 0.008 ✓ | 12.2 EB05 12.0 · IC025 +3.6 3/3 methods agree vs other Opioid Agonists: PRR 3.0 (3.0–3.1) | No label text to screen label has no adverse-reaction text | age-adj. PRR 5.1 · serious PRR 8.4 | no trial arm names this drug |
| Drug hypersensitivity | 10,257 | 9.6 9.5–9.8ROR 10.5 · calibrated p 0.028 ✓ | 9.2 EB05 9.0 · IC025 +3.2 3/3 methods agree vs other Opioid Agonists: PRR 7.2 (7.0–7.5) | No label text to screen label has no adverse-reaction text | age-adj. PRR 18.0 · serious PRR 2.8 · ♀ 81% (drug 53%) | no trial arm names this drug |
| Nausea | 5,662 | 1.2 1.2–1.3ROR 1.3 · calibrated p 0.482 | 1.2 EB05 1.2 · IC025 +0.3 vs other Opioid Agonists: PRR 1.5 (1.4–1.5) | No label text to screen label has no adverse-reaction text | age-adj. PRR 2.1 · serious PRR 1.2 | no trial arm names this drug |
| Dependence | 5,003 | 17.1 16.6–17.6ROR 17.8 · calibrated p 0.003 ✓ | 15.7 EB05 15.3 · IC025 +3.9 3/3 methods agree vs other Opioid Agonists: PRR 3.2 (3.0–3.3) | No label text to screen label has no adverse-reaction text | serious PRR 10.6 · 100% consumer | no trial arm names this drug |
| Drug ineffective (drug did not work) | 4,911 | 0.6 0.6–0.7ROR 0.6 · calibrated p 0.098 | 0.6 EB05 0.6 · IC025 -0.7 PRR-only: not supported by EBGM or IC vs other Opioid Agonists: PRR 1.3 (1.2–1.3) | Reporting / coding artifact | age-adj. PRR 1.3 · serious PRR 1.0 | no trial arm names this drug |
| Vomiting | 4,019 | 1.5 1.5–1.5ROR 1.5 · calibrated p 0.649 | 1.5 EB05 1.5 · IC025 +0.5 vs other Opioid Agonists: PRR 1.4 (1.3–1.4) | No label text to screen label has no adverse-reaction text | age-adj. PRR 2.4 · serious PRR 1.2 | no trial arm names this drug |
| Fatigue (tiredness) | 4,008 | 0.9 0.9–0.9ROR 0.9 · calibrated p 0.239 | 0.9 EB05 0.9 · IC025 -0.2 PRR-only: not supported by EBGM or IC vs other Opioid Agonists: PRR 1.5 (1.4–1.5) | No label text to screen label has no adverse-reaction text | age-adj. PRR 1.5 · serious PRR 0.9 | no trial arm names this drug |
| Drug abuse | 3,809 | 8.3 8.0–8.5ROR 8.5 · calibrated p 0.055 | 7.9 EB05 7.7 · IC025 +2.9 3/3 methods agree vs other Opioid Agonists: PRR 0.7 (0.7–0.8) | Reporting / coding artifact | age-adj. PRR 6.0 · serious PRR 5.4 | no trial arm names this drug |
| Anxiety | 3,473 | 2.1 2.1–2.2ROR 2.2 · calibrated p 0.969 | 2.1 EB05 2.1 · IC025 +1.0 3/3 methods agree vs other Opioid Agonists: PRR 2.1 (2.0–2.2) | No label text to screen label has no adverse-reaction text | age-adj. PRR 1.7 · serious PRR 1.9 | no trial arm names this drug |
Unlabeled candidate signals
Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.
✓ A hand-written Bradford Hill causality assessment exists for this drug: Morphine (opioids) ↔ Overdose / respiratory depression.
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Morphine?
In FDA FAERS, the most frequently co-reported reaction terms for Morphine are pain, emotional distress, drug withdrawal syndrome, toxicity to various agents, drug hypersensitivity, nausea. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Morphine have an FDA boxed warning?
No. The FDA label retrieved for Morphine has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Morphine causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 8a77894b-2137-4f46-8dff-5c7b773d4d16, effective 20260507; matched on
openfda.generic_name.exact:"MORPHINE" AND openfda.product_type:"HUMAN PRESCRIPTION DRUG") - PubChem CID 5288826 description (ChEBI)
- Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 1,212 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath - ClinicalTrials.gov API v2 (query
MORPHINE, results-bearing studies sorted by enrollment)
Page generated 2026-10-14. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.