What the label lists and what reports show
Hemin side effects
Hemin's FDA label: “The most common adverse reactions (occurring in >1% of patients) are: headache, pyrexia, infusion site reactions, and phlebitis.” FAERS holds 546 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 porphyria acute (62 reports).
- No generic listed
Check it at the source: the hemin FDA label on DailyMed (effective February 26, 2026); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (occurring in >1% of patients) are: headache, pyrexia, infusion site reactions, and phlebitis.
Table 1: Adverse Reactions in >1% of Patients Treated with PANHEMATIN
| Description | System Organ Class Preferred Term Total | Adverse Events N (% of Total Adverse Events) Possibly or Probably Related to Treatment |
|---|---|---|
| Cellulitis | 3 (1.5%) | 2 (1.0%) |
| Headache | 18 (9.2%) | 5 (2.6%) |
| Phlebitis / Injection site phlebitis | 7 (3.6%) | 6 (3.1%) |
| Rash | 3 (1.5%) | 3 (1.5%) |
| Pyrexia | 9 (4.6%) | 6 (3.1%) |
| Catheter-related Complication | 7 (3.6%) | 3 (1.5%) |
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 most common adverse reactions (occurring in >1% of patients) are: headache, pyrexia, infusion site reactions, and phlebitis. Most common adverse reactions in >1% of patients are headache, pyrexia, infusion site reactions, and phlebitis. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Recordati Rare Diseases Inc. at 1-888-575-8344 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials 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. The safety of PANHEMATIN use was evaluated in a compassionate use study. A total of 130 patients were treated with hemin for acute attacks, prophylaxis or both. Of those, 111 patients were administered hemin for treatment of 305 acute porphyria attacks and to 40 patients for prophylaxis. The majority (92%) of patients were Caucasian. Most (72%) were female; all adult patients had a mean age ± SD of 40.3 ± 12.3 years. Proportionally more females (15 out of 19) received prophylaxis or a combination of acute treatment and prophylaxis (19 out of 21). For the treatment of acute attacks, patients received 2 to 4 mg/kg/day PANHEMATIN intravenously for 1 to 9 doses. …
Source: FDA drug label, Recordati Rare Diseases, Inc., effective February 26, 2026 (SPL set 9984267a-4d57-4444-9bb5-16bca7dea691), via openFDA; the full label on DailyMed
What do FAERS reports show?
546 reports list hemin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 20 are coded as a death and 168 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 17 reactions below, 6 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?
- Hemin: 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