Two medicines, side by side
Azathioprine vs hydroxychloroquine
Azathioprine and hydroxychloroquine are both labeled for rheumatoid arthritis. Drugs@FDA records approvals of azathioprine since 1968 and of hydroxychloroquine since 1955. Pharmacies paid $0.124 per azathioprine 50 mg tablet and $0.149 per hydroxychloroquine 200 mg tablet (NADAC, October 7, 2026); the strengths differ, so the two prices are not like for like. In FDA's classes, azathioprine is a purine antimetabolite and hydroxychloroquine an antirheumatic agent.
Check it at the source: the azathioprine FDA label on DailyMed (effective November 8, 2025); the hydroxychloroquine FDA label on DailyMed (effective October 8, 2024).
Highlights of the azathioprine record
Azathioprine (Imuran) · label of November 8, 2025
MALIGNANCY Chronic immunosuppression with IMURAN, a purine antimetabolite increases risk of malignancy in humans. Reports of malignancy include post-transplant lymphoma and hepatosplenic T-cell lymphoma (HSTCL) in patients with inflammatory bowel disease. Physicians using this drug should be very familiar with this risk as well as with the mutagenic potential to both men and women and with possible hematologic toxicities. Physicians should inform patients of the risk of malignancy with IMURAN.
Used for
From the label: indicationsIMURAN is indicated as an adjunct for the prevention of rejection in renal homotransplantation. It is also indicated for the management of active rheumatoid arthritis to reduce signs and symptoms. Renal Homotransplantation: IMURAN is indicated as an adjunct for the prevention of rejection in renal homotransplantation. […]
On the market
- Earliest approval on file
- March 20, 1968
- Generic labelers
- 17 labelers
- Pharmacy cost
- $0.124 per tablet
Supply and safety
- Shortage
- No current entry
- Recalls
- 1
Highlights of the hydroxychloroquine record
Hydroxychloroquine (Plaquenil) · label of October 8, 2024
Used for
From the label: indicationsSOVUNA is an antimalarial and antirheumatic indicated for the: Treatment of uncomplicated malaria due to Plasmodium falciparum, Plasmodium malariae, Plasmodium ovale, and Plasmodium vivax in adult and pediatric patients. (1.1) Prophylaxis of malaria in geographic areas where chloroquine resistance is not reported in adult and pediatric patients. (1.1) Treatment of rheumatoid arthritis in adults. […]
On the market
- Earliest approval on file
- April 18, 1955
- Generic labelers
- 28 labelers
- Pharmacy cost
- $0.149 per tablet
Supply and safety
- Shortage
- A presentation being discontinued
- Recalls
- 2
Source: FDA drug labels via openFDA (Azathioprine label of November 8, 2025, Hydroxychloroquine label of October 8, 2024); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do azathioprine and hydroxychloroquine differ on the record?
In FDA's classes, azathioprine is a purine antimetabolite and hydroxychloroquine an antirheumatic agent.
Half-life, in each label's words: Azathioprine, “Maximum serum radioactivity occurs at 1 to 2 hours after oral 35 S-azathioprine and decays with a half-life of 5 hours.”; Hydroxychloroquine, “Results following a single oral dose of a 200 mg tablet demonstrated a half-life of hydroxychloroquine about 40 days in …”
Only the azathioprine label carries a boxed warning.
Generics: azathioprine since 1995; hydroxychloroquine since 1994 (Drugs@FDA).
| Azathioprine | Hydroxychloroquine | |
|---|---|---|
| Labeled for | Organ transplant rejection, Rheumatoid arthritis | Rheumatoid arthritis |
| Pharmacologic class | Purine Antimetabolite | Antimalarial, Antirheumatic Agent |
| How it works (label) | n/a | Malaria Hydroxychloroquine is a 4-aminoquinoline antimalarial [see Microbiology (12.4)] and antirheumatic agent. |
| Half-life (label) | Maximum serum radioactivity occurs at 1 to 2 hours after oral 35 S-azathioprine and decays with a half-life of 5 hours. | Results following a single oral dose of a 200 mg tablet demonstrated a half-life of hydroxychloroquine about 40 days in whole blood. |
| Earliest approval on file (Drugs@FDA) | March 20, 1968 | April 18, 1955 |
| First generic approved | March 31, 1995 | September 30, 1994 |
| Generic labelers (NDC) | 17 labelers | 28 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $0.124 per tablet (Azathioprine 50 mg tablet) | $0.149 per tablet (Hydroxychloroquine 200 mg tablet) |
| 12-month price change | -10% | -8% |
| Boxed warning | Yes | No |
| Shortage now | No current entry | A presentation being discontinued |
| Recalls recorded | 1 | 2 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 89,586 | 151,392 |
| DEA schedule | none | none |
Source: Drugs@FDA, FDA NDC Directory, CMS NADAC of October 7, 2026, FDA shortages and recalls, FAERS via openFDA (FDA files October 8, 2026)
What next?
- Alternatives to azathioprine
- every medicine labeled for the same conditions