A fixed combination of 2 drugs in one pill.
Sold as Alavert D, Allerclear, Claritin-D, Wal-itin D.
A combination is graded by its riskiest ingredient: each part of the score is the lowest of the ingredients' scores. This grade answers one narrow question: how strong is the public evidence and safety record behind this drug, and how clean is its money trail and court record? It is not a verdict on whether the drug is right for you.
First approved 08/29/1975 · graded here only, no page of its own yet
SAF BEVI FREG ACON AOPT A
Ingredients with a page of their own link to it: the FDA label, side-effect reports, recalls, evidence, and payments behind this grade are there.
Score breakdown (66/100)
Safety ×35%
B
Evidence ×25%
F
Regulatory ×15%
A
Money & lawsuits ×15%
B
Options ×10%
C
Safety: 78
Graded by its riskiest ingredient, pseudoephedrine (78)
Listed by the independent review Prescrire as a drug to avoid (2026 edition) (-10)
Death appears in 2.6x the share of reports seen across all of FAERS (-12)
Evidence: 22
Graded by its riskiest ingredient, pseudoephedrine (22)
130 randomized trials and 3 systematic reviews/meta-analyses indexed in PubMed
Prescrire's independent reviewers find its harm-benefit balance unfavourable versus alternatives (-10)
No Cochrane review found (-5)
Only 11% of completed registered trials posted results (-15)
'Drug ineffective' is the single most-reported item about this drug in FAERS (-5)
Regulatory history: 91
Graded by its riskiest ingredient, loratadine (91)
Recalls since 2016: 0 Class I, 1 Class II, 0 Class III across 38 generic makers (-1)
11 label changes approved since 2021: the safety story is still moving (-8)
Money & lawsuits: 85
Graded by its riskiest ingredient, loratadine (85)
Maker paid $500 million in 2002 to settle federal allegations naming this drug (Poor manufacturing practices) (-15)
Pharma paid doctors $0 tied to this drug last year: negligible
Not named in any pending federal MDL
Options: 70
Graded by its riskiest ingredient, loratadine (70)
Generic versions approved (38 applications)
No same-class alternatives found: little leverage to switch (-30)
Money and lawsuits
In 2024, drug companies reported $0 in payments to US physicians and hospitals tied to this combination's brands across 0 transactions.
No pending federal MDL names this combination or its brands.
The ingredients' own payments and lawsuits are on their pages and already count toward this grade.
Who takes it and what it costs
Not in the Medicare Part D spending file.
Questions to ask your prescriber
This is a fixed combination of loratadine and pseudoephedrine. Why both together, instead of only the one I need?
The maker paid $500 million in 2002 to settle federal allegations about how this drug was marketed. Is my use one of the uses that was promoted improperly?
The most-reported problems in FDA's adverse event data are fatigue, nausea, headache. How would we recognize and handle those?
Off-label use is among the most-reported items for this drug. Is my use on-label, and if not, what evidence supports it?
What result are we expecting, by when, and what is the plan if it does not happen?
If 100 people like me took this drug, how many would actually get better because of it, and how many would be harmed by it? (Doctors call these the number needed to treat and the number needed to harm.)
An independent reviewer (Prescrire) lists this as a drug to avoid because the harms outweigh the benefits versus alternatives. What is your view on that?
The most-reported problems in FDA's adverse event data are pain, systemic lupus erythematosus, rheumatoid arthritis. How would we recognize and handle those?
Why this one over phenylephrine, phenylpropanolamine? What would make you pick one of those instead?