Navigating medication use during pregnancy can be challenging, especially when dealing with persistent allergy symptoms. Azelastine, a common prescription and over-the-counter antihistamine nasal spray, is effective for many, but its use during pregnancy requires careful consideration. This article delves into the research, official classifications, and expert recommendations regarding the safety of azelastine for expectant mothers.
What is Azelastine and How Does It Work?
Azelastine is a second-generation antihistamine available as a nasal spray (Astepro, Astelin) and eye drops (Optivar) [1.2.3]. It works by blocking histamine, a substance your body releases during an allergic reaction [1.7.2]. This action helps relieve symptoms like sneezing, runny nose, and itchy or watery eyes. Unlike some older antihistamines, azelastine is known for its rapid onset of action [1.7.2]. After intranasal use, about 40% of the medication is absorbed into the bloodstream, which is an important factor when considering its use during pregnancy [1.7.3].
Is Azelastine Safe in Pregnancy? What the Research Says
There are no adequate and well-controlled studies on azelastine use in pregnant women [1.2.1, 1.2.3]. This lack of human data leads healthcare providers to be cautious. The U.S. Food and Drug Administration (FDA) previously assigned azelastine to Pregnancy Category C [1.3.1].
Understanding Pregnancy Risk Categories
The FDA has transitioned from its letter-based category system (A, B, C, D, X) to the Pregnancy and Lactation Labeling Rule (PLLR), which provides a narrative summary of risks. However, the historical Category C classification is still a useful reference point. Category C means that animal reproduction studies have shown an adverse effect on the fetus, but there are no adequate studies in humans [1.3.1]. Medications in this category may be used if the potential benefit justifies the potential risk to the fetus [1.3.1].
Findings from Animal Studies
Animal studies on azelastine have shown developmental toxicity, including skeletal abnormalities and fetal death, but only at very high oral doses—many times greater than the maximum recommended human daily intranasal dose [1.6.1, 1.6.2]. At doses closer to what a human would be exposed to, animal studies did not show an increased chance of birth defects [1.6.3]. The relevance of the high-dose findings to humans is considered questionable [1.6.2].
Potential Risks and Weighing the Benefits
Given the limited human data, the primary concern is the theoretical risk of adverse effects on the developing fetus. The decision to use azelastine during pregnancy involves a careful risk-benefit analysis conducted by you and your doctor. If allergy symptoms are severe and unmanaged by safer alternatives, and they significantly impact your quality of life, a doctor might determine that the benefit of using azelastine outweighs the unknown risks.
The most common side effects for the user include a bitter taste in the mouth, headache, drowsiness, and nasal irritation [1.3.3]. While drowsiness is less common than with first-generation antihistamines, it can still occur [1.7.1].
Comparing Allergy Medications for Pregnancy
When considering allergy treatment during pregnancy, it is helpful to compare azelastine with other available options.
| Medication | Type | Pregnancy Status | Key Considerations |
|---|---|---|---|
| Azelastine (Astepro) | 2nd-Gen Antihistamine (Nasal) | Use with caution (Former Category C) | Lack of human data; use only if benefits outweigh risks [1.3.1]. |
| Budesonide (Rhinocort) | Corticosteroid (Nasal) | Generally considered safe (Category B) | Often a preferred nasal steroid during pregnancy with low systemic absorption [1.9.1, 1.9.2, 1.4.3]. |
| Loratadine (Claritin) | 2nd-Gen Antihistamine (Oral) | Generally considered safe (Category B) | Widely used with substantial reassuring data; non-drowsy for most people [1.10.1, 1.5.5]. |
| Cetirizine (Zyrtec) | 2nd-Gen Antihistamine (Oral) | Generally considered safe (Category B) | Also considered a drug of choice, with good safety data available [1.11.1, 1.11.2, 1.5.5]. |
Safer Alternatives for Managing Allergies While Pregnant
Before turning to medication, healthcare providers often recommend non-pharmacological approaches:
- Allergen Avoidance: Limit exposure to known triggers like pollen, dust mites, and pet dander [1.4.5].
- Saline Nasal Sprays/Rinses: Using a saline solution can help clear nasal passages without medication [1.5.3].
- Environmental Controls: Using air purifiers with HEPA filters and keeping windows closed during high pollen seasons can help [1.4.5].
If these methods are insufficient, doctors typically recommend medications with more established safety records in pregnancy. Second-generation oral antihistamines like loratadine (Claritin) and cetirizine (Zyrtec) are often considered first-line choices [1.5.2, 1.5.5]. Among nasal sprays, the corticosteroid budesonide (Rhinocort) is frequently preferred due to its extensive safety data [1.9.1, 1.4.4].
What If You've Already Used Azelastine While Pregnant?
If you have used azelastine before realizing you were pregnant, it's important not to panic. The available animal data suggests that problems are unlikely, especially at standard doses [1.6.3]. The most crucial step is to speak with your healthcare provider. They can discuss your specific situation, review the timing and dosage, and advise you on the best course of action for managing your allergies for the remainder of your pregnancy.
Conclusion: A Cautious and Collaborative Approach
The answer to whether azelastine is safe in pregnancy is not a simple yes or no. Due to the absence of robust human studies, it is not considered a first-line treatment for allergies in pregnant women [1.2.1, 1.6.3]. The decision should always be made in consultation with a healthcare professional who can weigh the severity of your symptoms against the potential risks. For most people, safer alternatives with well-established safety profiles are the preferred choice.
For more information, you can review resources from organizations like MotherToBaby, which provides evidence-based information on exposures during pregnancy.
