Drug · FAERS side-effect profile with label screen
Morphine side effects: what 74,159 FDA adverse event reports show
Brand names
Opium
openFDA label
Who reports
74,159 reports · 87% serious · 20,345 with death outcome · 54% 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
DESCRIPTION Opium Tincture, USP (Deodorized), is for oral administration. It is freed from unpleasant odor or nauseating substances by "denarcotization" with a petroleum distillate. Opium tincture is a clear, reddish-brown hydroalcoholic solution.
FDA label, Description section
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 3Lab value / disease marker 7No label text to screen 30
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). 1,155 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 |
|---|---|---|---|---|---|---|
| Grip strength | 102 | 223.3 172.1–289.7ROR 223.6 · calibrated p 3e-10 ✓ | 121.5 EB05 103.0 · IC025 +6.0 3/3 methods agree vs other Opioid Agonists: only this drug | No label text to screen label has no adverse-reaction text | serious n=102 · ♀ 100% (drug 54%) · 100% clinician | no trial arm names this drug |
| Vaginal flatulence | 84 | 107.1 83.3–137.8ROR 107.2 · calibrated p 1e-7 ✓ | 76.3 EB05 63.6 · IC025 +5.4 3/3 methods agree vs other Opioid Agonists: PRR 0.7 (0.6–0.9) | No label text to screen label has no adverse-reaction text | serious n=84 · ♀ 100% (drug 54%) | no trial arm names this drug |
| Anti-cyclic citrullinated peptide antibody | 140 | 75.0 62.2–90.4ROR 75.1 · calibrated p 1e-6 ✓ | 58.8 EB05 51.1 · IC025 +5.3 3/3 methods agree vs other Opioid Agonists: PRR 3.3 (2.6–4.1) | Lab value / disease marker | serious n=140 · ♀ 100% (drug 54%) · 100% clinician | no trial arm names this drug |
| Neurologic neglect syndrome | 106 | 65.9 53.4–81.5ROR 66.0 · calibrated p 3e-6 ✓ | 53.0 EB05 45.1 · IC025 +5.1 3/3 methods agree vs other Opioid Agonists: PRR 3.0 (2.3–3.9) | No label text to screen label has no adverse-reaction text | serious n=106 · ♀ 100% (drug 54%) · 100% clinician | no trial arm names this drug |
| Lupus vulgaris | 213 | 61.6 53.1–71.4ROR 61.7 · calibrated p 4e-6 ✓ | 50.4 EB05 44.9 · IC025 +5.3 3/3 methods agree vs other Opioid Agonists: PRR 2.8 (2.4–3.4) | No label text to screen label has no adverse-reaction text | serious n=213 · ♀ 100% (drug 54%) · 100% clinician | no trial arm names this drug |
| Adjustment disorder with depressed mood | 253 | 40.5 35.5–46.2ROR 40.6 · calibrated p 5e-5 ✓ | 35.4 EB05 31.9 · IC025 +4.8 3/3 methods agree vs other Opioid Agonists: PRR 6.2 (5.0–7.7) | No label text to screen label has no adverse-reaction text | serious n=253 · ♀ 100% (drug 54%) · 100% clinician | no trial arm names this drug |
| Carotid artery thrombosis | 106 | 40.0 32.6–49.0ROR 40.0 · calibrated p 6e-5 ✓ | 34.9 EB05 29.7 · IC025 +4.6 3/3 methods agree vs other Opioid Agonists: PRR 2.9 (2.3–3.8) | No label text to screen label has no adverse-reaction text | serious n=106 · ♀ 100% (drug 54%) · 100% clinician | no trial arm names this drug |
| Seronegative arthritis | 139 | 39.9 33.4–47.6ROR 40.0 · calibrated p 6e-5 ✓ | 34.9 EB05 30.3 · IC025 +4.7 3/3 methods agree vs other Opioid Agonists: PRR 3.2 (2.5–4.0) | No label text to screen label has no adverse-reaction text | serious n=139 · ♀ 100% (drug 54%) · 100% clinician | no trial arm names this drug |
| Dislocation of vertebra | 273 | 39.5 34.8–44.8ROR 39.6 · calibrated p 6e-5 ✓ | 34.6 EB05 31.3 · IC025 +4.8 3/3 methods agree vs other Opioid Agonists: PRR 6.4 (5.2–7.9) | No label text to screen label has no adverse-reaction text | serious n=273 · ♀ 100% (drug 54%) · 91% clinician | no trial arm names this drug |
| Retinitis | 192 | 36.7 31.5–42.6ROR 36.8 · calibrated p 9e-5 ✓ | 32.4 EB05 28.7 · IC025 +4.7 3/3 methods agree vs other Opioid Agonists: PRR 1.9 (1.6–2.3) | No label text to screen label has no adverse-reaction text | serious n=192 · ♀ 100% (drug 54%) · 100% clinician | no trial arm names this drug |
| Maternal exposure during delivery | 111 | 36.4 29.9–44.3ROR 36.4 · calibrated p 1e-4 ✓ | 32.1 EB05 27.4 · IC025 +4.5 3/3 methods agree vs other Opioid Agonists: PRR 1.3 (1.1–1.6) | Reporting / coding artifact | serious n=88 · ♀ 100% (drug 54%) · 100% clinician | no trial arm names this drug |
| X-ray abnormal | 194 | 34.4 29.6–39.9ROR 34.5 · calibrated p 1e-4 ✓ | 30.6 EB05 27.2 · IC025 +4.6 3/3 methods agree vs other Opioid Agonists: only this drug | Lab value / disease marker | serious n=194 · ♀ 100% (drug 54%) · 100% clinician | no trial arm names this drug |
| Deep vein thrombosis postoperative | 208 | 33.5 29.0–38.6ROR 33.6 · calibrated p 2e-4 ✓ | 29.9 EB05 26.6 · IC025 +4.6 3/3 methods agree vs other Opioid Agonists: PRR 4.9 (3.9–6.1) | No label text to screen label has no adverse-reaction text | serious n=208 · ♀ 100% (drug 54%) · 100% clinician | no trial arm names this drug |
| Porphyria acute | 123 | 27.6 22.9–33.2ROR 27.6 · calibrated p 4e-4 ✓ | 25.1 EB05 21.6 · 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=123 · ♀ 100% (drug 54%) · 100% clinician | no trial arm names this drug |
| Adjustment disorder | 110 | 26.0 21.4–31.6ROR 26.0 · calibrated p 6e-4 ✓ | 23.7 EB05 20.2 · IC025 +4.1 3/3 methods agree vs other Opioid Agonists: PRR 3.1 (2.4–4.1) | No label text to screen label has no adverse-reaction text | serious n=109 · ♀ 100% (drug 54%) · 100% clinician | no trial arm names this drug |
| Accidental death | 156 | 25.9 22.0–30.5ROR 26.0 · calibrated p 6e-4 ✓ | 23.7 EB05 20.8 · IC025 +4.2 3/3 methods agree vs other Opioid Agonists: PRR 2.4 (1.9–3.0) | No label text to screen label has no adverse-reaction text | serious n=156 · ♀ 0% (drug 54%) · 100% clinician | no trial arm names this drug |
| Swollen joint count increased | 242 | 23.7 20.8–27.0ROR 23.8 · calibrated p 9e-4 ✓ | 21.9 EB05 19.7 · IC025 +4.2 3/3 methods agree vs other Opioid Agonists: PRR 3.7 (3.1–4.5) | Lab value / disease marker | serious n=242 · ♀ 100% (drug 54%) · 100% clinician | no trial arm names this drug |
| Bradypnoea | 202 | 22.9 19.9–26.5ROR 23.0 · calibrated p 0.001 ✓ | 21.2 EB05 18.9 · IC025 +4.1 3/3 methods agree vs other Opioid Agonists: PRR 2.0 (1.6–2.3) | No label text to screen label has no adverse-reaction text | serious n=200 · 100% clinician | no trial arm names this drug |
| Contrast media allergy | 134 | 22.8 19.1–27.2ROR 22.8 · calibrated p 0.001 ✓ | 21.1 EB05 18.2 · IC025 +4.0 3/3 methods agree vs other Opioid Agonists: PRR 3.6 (2.8–4.7) | No label text to screen label has no adverse-reaction text | serious n=133 · ♀ 100% (drug 54%) | no trial arm names this drug |
| Facet joint syndrome | 231 | 22.3 19.5–25.5ROR 22.4 · calibrated p 0.001 ✓ | 20.7 EB05 18.5 · IC025 +4.1 3/3 methods agree vs other Opioid Agonists: PRR 10.3 (7.9–13.6) | No label text to screen label has no adverse-reaction text | serious n=231 · ♀ 100% (drug 54%) | no trial arm names this drug |
| Bone erosion | 254 | 21.8 19.2–24.7ROR 21.8 · calibrated p 0.001 ✓ | 20.2 EB05 18.2 · IC025 +4.1 3/3 methods agree vs other Opioid Agonists: PRR 2.7 (2.2–3.1) | No label text to screen label has no adverse-reaction text | serious n=254 · ♀ 100% (drug 54%) · 91% clinician | no trial arm names this drug |
| Respiratory depression | 832 | 20.5 19.1–22.0ROR 20.7 · calibrated p 0.002 ✓ | 19.2 EB05 18.1 · IC025 +4.1 3/3 methods agree vs other Opioid Agonists: PRR 1.4 (1.3–1.6) | No label text to screen label has no adverse-reaction text | age-adj. PRR 16.3 · serious PRR 12.7 · 91% clinician | no trial arm names this drug |
| Personality disorder | 160 | 18.2 15.5–21.4ROR 18.3 · calibrated p 0.003 ✓ | 17.1 EB05 15.0 · IC025 +3.8 3/3 methods agree vs other Opioid Agonists: PRR 3.4 (2.7–4.3) | No label text to screen label has no adverse-reaction text | serious n=157 · ♀ 100% (drug 54%) | no trial arm names this drug |
| Rheumatic fever | 265 | 18.2 16.1–20.6ROR 18.3 · calibrated p 0.003 ✓ | 17.1 EB05 15.5 · IC025 +3.9 3/3 methods agree vs other Opioid Agonists: PRR 3.4 (2.9–4.1) | No label text to screen label has no adverse-reaction text | serious n=265 · ♀ 100% (drug 54%) · 93% clinician | no trial arm names this drug |
| Female genital tract fistula | 104 | 18.1 14.9–22.1ROR 18.2 · calibrated p 0.003 ✓ | 17.0 EB05 14.4 · IC025 +3.7 3/3 methods agree vs other Opioid Agonists: PRR 0.8 (0.6–1.0) | No label text to screen label has no adverse-reaction text | serious n=104 · ♀ 100% (drug 54%) | no trial arm names this drug |
| Rheumatoid factor positive | 320 | 16.6 14.8–18.5ROR 16.6 · calibrated p 0.005 ✓ | 15.7 EB05 14.3 · IC025 +3.8 3/3 methods agree vs other Opioid Agonists: PRR 2.4 (2.1–2.8) | Lab value / disease marker | serious n=320 · ♀ 100% (drug 54%) · 100% clinician | no trial arm names this drug |
| C-reactive protein abnormal | 354 | 16.5 14.8–18.3ROR 16.6 · calibrated p 0.005 ✓ | 15.6 EB05 14.3 · IC025 +3.8 3/3 methods agree vs other Opioid Agonists: PRR 11.1 (8.8–13.9) | Lab value / disease marker | serious n=354 · ♀ 100% (drug 54%) · 94% clinician | no trial arm names this drug |
| Peripheral venous disease | 213 | 15.9 13.8–18.2ROR 15.9 · calibrated p 0.006 ✓ | 15.0 EB05 13.4 · IC025 +3.6 3/3 methods agree vs other Opioid Agonists: PRR 10.7 (8.0–14.2) | No label text to screen label has no adverse-reaction text | serious n=211 · ♀ 100% (drug 54%) · 91% clinician | no trial arm names this drug |
| Exposure via ingestion | 136 | 15.9 13.4–18.9ROR 15.9 · calibrated p 0.006 ✓ | 15.0 EB05 13.0 · IC025 +3.6 3/3 methods agree vs other Opioid Agonists: only this drug | Reporting / coding artifact | serious n=132 · 100% clinician | no trial arm names this drug |
| Obliterative bronchiolitis | 70 | 15.7 12.3–20.0ROR 15.7 · calibrated p 0.006 ✓ | 14.8 EB05 12.1 · IC025 +3.4 3/3 methods agree vs other Opioid Agonists: PRR 4.1 (2.9–5.9) | No label text to screen label has no adverse-reaction text | serious n=70 · ♀ 100% (drug 54%) · 100% clinician | no trial arm names this drug |
| Drug tolerance decreased | 144 | 15.3 12.9–18.1ROR 15.3 · calibrated p 0.007 ✓ | 14.5 EB05 12.6 · IC025 +3.5 3/3 methods agree vs other Opioid Agonists: PRR 3.9 (3.0–5.0) | No label text to screen label has no adverse-reaction text | serious n=143 · ♀ 100% (drug 54%) · 100% clinician | no trial arm names this drug |
| Sedation complication | 128 | 15.2 12.7–18.2ROR 15.2 · calibrated p 0.007 ✓ | 14.4 EB05 12.4 · IC025 +3.5 3/3 methods agree vs other Opioid Agonists: PRR 0.6 (0.5–0.7) | Reporting / coding artifact | serious n=127 | no trial arm names this drug |
| Substance use disorder | 146 | 14.0 11.9–16.6ROR 14.1 · calibrated p 0.009 ✓ | 13.4 EB05 11.6 · IC025 +3.4 3/3 methods agree vs other Opioid Agonists: PRR 1.1 (0.9–1.3) | No label text to screen label has no adverse-reaction text | serious n=146 | no trial arm names this drug |
| Radiculopathy | 125 | 14.0 11.7–16.8ROR 14.0 · calibrated p 0.010 ✓ | 13.3 EB05 11.5 · IC025 +3.4 3/3 methods agree vs other Opioid Agonists: PRR 0.8 (0.7–1.0) | No label text to screen label has no adverse-reaction text | serious n=125 · ♀ 100% (drug 54%) | no trial arm names this drug |
| Respiratory rate decreased | 142 | 13.3 11.2–15.7ROR 13.3 · calibrated p 0.012 ✓ | 12.7 EB05 11.0 · IC025 +3.3 3/3 methods agree vs other Opioid Agonists: PRR 1.2 (1.0–1.5) | Lab value / disease marker | serious n=128 · 100% clinician | no trial arm names this drug |
| Miosis | 358 | 13.3 11.9–14.7ROR 13.3 · calibrated p 0.011 ✓ | 12.7 EB05 11.6 · IC025 +3.5 3/3 methods agree vs other Opioid Agonists: PRR 1.3 (1.2–1.5) | No label text to screen label has no adverse-reaction text | serious PRR 8.6 · 100% clinician | no trial arm names this drug |
| Temperature regulation disorder | 96 | 12.9 10.6–15.9ROR 13.0 · calibrated p 0.013 ✓ | 12.3 EB05 10.3 · IC025 +3.2 3/3 methods agree vs other Opioid Agonists: PRR 1.2 (0.9–1.5) | No label text to screen label has no adverse-reaction text | serious n=93 · ♀ 100% (drug 54%) · 100% clinician | no trial arm names this drug |
| Anti-cyclic citrullinated peptide antibody positive | 295 | 12.2 10.9–13.7ROR 12.2 · calibrated p 0.016 ✓ | 11.7 EB05 10.6 · IC025 +3.3 3/3 methods agree vs other Opioid Agonists: PRR 3.3 (2.8–3.9) | Lab value / disease marker | serious PRR 7.8 · ♀ 100% (drug 54%) · 100% clinician | no trial arm names this drug |
| Poisoning | 513 | 11.9 10.9–13.0ROR 12.0 · calibrated p 0.017 ✓ | 11.5 EB05 10.7 · IC025 +3.4 3/3 methods agree vs other Opioid Agonists: PRR 3.6 (3.2–4.1) | No label text to screen label has no adverse-reaction text | serious PRR 7.7 · 96% clinician | no trial arm names this drug |
| Duodenal ulcer perforation | 288 | 11.5 10.2–12.9ROR 11.5 · calibrated p 0.020 ✓ | 11.0 EB05 10.0 · IC025 +3.3 3/3 methods agree vs other Opioid Agonists: PRR 3.8 (3.2–4.6) | No label text to screen label has no adverse-reaction text | serious PRR 7.3 · ♀ 100% (drug 54%) · 91% clinician | 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 |
|---|---|---|---|
| Suicidality | 2,350 | 2.72.6–2.8 | signal |
| Dependence / withdrawal | 2,819 | 2.72.6–2.8 | signal |
| Pancreatitis | 733 | 2.62.4–2.8 | signal |
| Kidney injury | 4,000 | 2.52.4–2.6 | signal |
| Neutropenia / agranulocytosis | 2,116 | 2.42.3–2.5 | signal |
| Interstitial lung disease | 816 | 2.42.3–2.6 | signal |
| Thrombocytopenia | 1,862 | 2.42.3–2.5 | signal |
| Serious infection | 6,439 | 2.42.3–2.4 | signal |
| Anaemia | 2,460 | 2.32.2–2.4 | signal |
| Venous thromboembolism | 1,754 | 2.32.2–2.4 | signal |
| Hyponatraemia | 640 | 2.32.1–2.4 | signal |
| Liver injury | 2,373 | 2.22.1–2.3 | signal |
| Anaphylaxis / angioedema | 910 | 2.11.9–2.2 | raised |
| Gi bleeding | 1,315 | 2.01.9–2.2 | raised |
| Arrhythmia / qt | 1,354 | 2.01.9–2.1 | raised |
| Rhabdomyolysis / myopathy | 549 | 1.91.8–2.1 | raised |
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 |
|---|---|---|---|---|---|---|
| Pain | 6,005 | 2.8 2.7–2.8ROR 2.9 · calibrated p 0.648 | 2.8 EB05 2.7 · IC025 +1.4 3/3 methods agree vs other Opioid Agonists: PRR 0.6 (0.6–0.6) | No label text to screen label has no adverse-reaction text | age-adj. PRR 2.6 · serious PRR 2.6 | no trial arm names this drug |
| Nausea | 5,726 | 2.1 2.0–2.1ROR 2.1 · calibrated p 0.977 | 2.1 EB05 2.0 · IC025 +1.0 3/3 methods agree vs other Opioid Agonists: PRR 1.5 (1.5–1.5) | No label text to screen label has no adverse-reaction text | age-adj. PRR 1.8 · serious PRR 2.2 | no trial arm names this drug |
| Drug ineffective (drug did not work) | 5,222 | 1.1 1.1–1.2ROR 1.1 · calibrated p 0.393 | 1.1 EB05 1.1 · IC025 +0.1 vs other Opioid Agonists: PRR 1.4 (1.3–1.4) | Reporting / coding artifact | age-adj. PRR 1.3 · serious PRR 1.7 | no trial arm names this drug |
| Vomiting | 4,468 | 2.7 2.6–2.8ROR 2.8 · calibrated p 0.687 | 2.7 EB05 2.6 · IC025 +1.4 3/3 methods agree vs other Opioid Agonists: PRR 1.6 (1.6–1.7) | No label text to screen label has no adverse-reaction text | age-adj. PRR 2.3 · serious PRR 2.3 | no trial arm names this drug |
| Death | 4,423 | 1.5 1.4–1.5ROR 1.5 · calibrated p 0.631 | 1.5 EB05 1.4 · IC025 +0.5 vs other Opioid Agonists: PRR 0.5 (0.5–0.5) | Outcome field, not a reaction | age-adj. PRR 1.7 · serious PRR 1.0 | no trial arm names this drug |
| Fatigue (tiredness) | 4,302 | 1.6 1.5–1.6ROR 1.6 · calibrated p 0.709 | 1.6 EB05 1.5 · IC025 +0.6 vs other Opioid Agonists: PRR 1.6 (1.6–1.7) | No label text to screen label has no adverse-reaction text | age-adj. PRR 1.4 · serious PRR 1.7 | no trial arm names this drug |
| Toxicity to various agents | 4,200 | 7.2 7.0–7.5ROR 7.6 · calibrated p 0.077 | 7.1 EB05 6.9 · IC025 +2.8 3/3 methods agree vs other Opioid Agonists: PRR 0.7 (0.6–0.7) | No label text to screen label has no adverse-reaction text | age-adj. PRR 6.4 · serious PRR 4.8 · 92% clinician | no trial arm names this drug |
| Off label use (used outside approved label) | 4,059 | 1.3 1.3–1.4ROR 1.3 · calibrated p 0.537 | 1.3 EB05 1.3 · IC025 +0.4 vs other Opioid Agonists: PRR 1.7 (1.7–1.8) | Reporting / coding artifact | age-adj. PRR 1.2 · serious PRR 1.4 | no trial arm names this drug |
| Diarrhoea (diarrhea) | 3,755 | 1.7 1.6–1.7ROR 1.7 · calibrated p 0.763 | 1.7 EB05 1.6 · IC025 +0.7 vs other Opioid Agonists: PRR 1.8 (1.8–1.9) | No label text to screen label has no adverse-reaction text | age-adj. PRR 1.5 · serious PRR 1.7 | no trial arm names this drug |
| Dyspnoea (shortness of breath) | 3,601 | 1.8 1.7–1.9ROR 1.8 · calibrated p 0.857 | 1.8 EB05 1.8 · IC025 +0.8 vs other Opioid Agonists: PRR 1.8 (1.7–1.8) | No label text to screen label has no adverse-reaction text | age-adj. PRR 1.7 · serious PRR 1.6 | no trial arm names this drug |
| Headache | 3,147 | 1.4 1.4–1.5ROR 1.4 · calibrated p 0.603 | 1.4 EB05 1.4 · IC025 +0.4 vs other Opioid Agonists: PRR 1.6 (1.6–1.7) | No label text to screen label has no adverse-reaction text | age-adj. PRR 1.2 · serious PRR 1.7 · ♀ 75% (drug 54%) | no trial arm names this drug |
| Pneumonia (lung infection) | 3,042 | 2.7 2.6–2.8ROR 2.7 · calibrated p 0.714 | 2.7 EB05 2.6 · IC025 +1.4 3/3 methods agree vs other Opioid Agonists: PRR 1.9 (1.8–1.9) | No label text to screen label has no adverse-reaction text | age-adj. PRR 2.5 · serious PRR 1.8 | no trial arm names this drug |
| Pyrexia (fever) | 3,005 | 2.5 2.4–2.6ROR 2.5 · calibrated p 0.801 | 2.5 EB05 2.4 · IC025 +1.2 3/3 methods agree vs other Opioid Agonists: PRR 1.8 (1.7–1.9) | No label text to screen label has no adverse-reaction text | age-adj. PRR 2.1 · serious PRR 1.9 | no trial arm names this drug |
| Drug abuse | 2,829 | 9.9 9.5–10.2ROR 10.2 · calibrated p 0.030 ✓ | 9.6 EB05 9.3 · IC025 +3.2 3/3 methods agree vs other Opioid Agonists: PRR 0.5 (0.5–0.5) | Reporting / coding artifact | age-adj. PRR 8.4 · serious PRR 6.4 · 91% clinician | no trial arm names this drug |
| Malaise (feeling unwell) | 2,671 | 1.7 1.7–1.8ROR 1.7 · calibrated p 0.799 | 1.7 EB05 1.7 · IC025 +0.7 vs other Opioid Agonists: PRR 1.7 (1.7–1.8) | No label text to screen label has no adverse-reaction text | age-adj. PRR 1.7 · serious PRR 1.7 | 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, nausea, vomiting, fatigue, toxicity to various agents, diarrhoea. 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") - 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, 1,195 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.