What the label lists and what reports show
Cocaine side effects
Cocaine's FDA label: “The most common adverse reactions (> 1%) occurring in patients treated with NUMBRINO were hypertension, tachycardia, and sinus tachycardia.” FAERS holds 417 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 cardiac arrest (94 reports).
- No generic listed
- Boxed warning
- DEA Schedule II
Check it at the source: the cocaine FDA label on DailyMed (effective January 12, 2026, OMNIVIUM PHARMACEUTICALS LLC.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (> 1%) occurring in patients treated with NUMBRINO were hypertension, tachycardia, and sinus tachycardia.
A table the label prints in its adverse reactions section without a title; its column headings name the groups compared
| Reaction | NUMBRINO, 4% (N=259) n, % | NUMBRINO, 10% (N=259) n, % | Placebo (N=128) n, % |
|---|---|---|---|
| Vascular Disorders | 203 (78) | 224 (87) | 86 (67) |
| Hypertension | 201 (78) | 220 (85) | 85 (66) |
| Cardiac Disorders | 31 (12) | 47 (18) | 10 (8) |
| Tachycardia | 12 (5) | 28 (11) | 1 (1) |
| Bradycardia | 8 (3) | 1 (0.4) | 5 (4) |
| Sinus tachycardia | 6 (2) | 9 (4) | 0 |
| Investigations | 13 (5) | 30 (12) | 8 (6) |
| QRS prolonged | 4 (2) | 8 (3) | 3 (2) |
| QT interval prolonged | 7 (3) | 10 (4) | 3 (2) |
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 treatment-emergent adverse events are discussed in more detailed in other sections of the labeling: Increases in Blood Pressure and Heart Rate [see Warnings and Precautions ( 5.3 )] The most common adverse reactions (> 1%) occurring in patients treated with NUMBRINO were hypertension, tachycardia, and sinus tachycardia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Omnivium Pharmaceuticals LLC at 1-888-807-1048 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. NUMBRINO nasal solution has been evaluated in one Phase 1 study, one QT study and two Phase 3 studies, which included 702 adult subjects who received a single application of NUMBRINO nasal solution 4%, NUMBRINO nasal solution 10%, or placebo. The randomized, double-blind, placebo controlled Phase 3 studies were conducted in adult patients undergoing diagnostic procedures and surgeries on or through the mucous membranes of the nasal cavities, of which 316 received NUMBRINO nasal solution 4%, 318 received NUMBRINO nasal solution 10%, and 168 received placebo. Safety was evaluated for up to 7 days after dosing.
Source: FDA drug label, OMNIVIUM PHARMACEUTICALS LLC., effective January 12, 2026 (SPL set d724b5b4-6654-4bf5-9eed-e2c7943084ed), via openFDA; the full label on DailyMed
What do FAERS reports show?
417 reports list cocaine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 248 are coded as a death and 152 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. Of the 20 reactions below, 2 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.
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?
- Cocaine: 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