Drug · FAERS side-effect profile with label screen
Magnesium Sulfate side effects: what 12,964 FDA adverse event reports show
Drug class
Not stated in label
Who reports
12,964 reports · 90% serious · 2,099 with death outcome · 60% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Magnesium Sulfate in 5% Dextrose Injection, USP is indicated for: • Prevention of eclampsia in patients with preeclampsia • Treatment of seizures and prevention of recurrent seizures in patients with eclampsia Magnesium Sulfate in 5% Dextrose Injection.
FDA label, Indications and Usage
What it is
Magnesium Sulfate in 5% Dextrose Injection, USP is a sterile, nonpyrogenic solution of magnesium sulfate heptahydrate and dextrose in water for injection for intravenous use. Each 100 mL conta.
FDA label, Description section
Boxed warning
None in the current label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation.
Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)?
That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.
Causality screen of the 40 strongest signals
Labeled (related wording) 2Likely indication confounding 2Reporting / coding artifact 1Lab value / disease marker 5Not in label — unassessed 30
What the badges mean
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 1,119 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Normal labour | 107 | 5,330.1 3,592.5–7,908.3ROR 5,374.5 · χ² 130,025 / p <1e-300 | 1,005.2 EB05 855.2 · IC025 +7.2 3/3 methods agree | Not in label — unassessed | serious n=107 · ♀ 100% (drug 60%) | not reported in cached trials |
| Vaginal flatulence | 153 | 1,636.9 1,307.1–2,049.7ROR 1,656.4 · χ² 122,605 / p <1e-300 | 733.4 EB05 640.9 · IC025 +7.5 3/3 methods agree | Not in label — unassessed | serious n=153 · ♀ 100% (drug 60%) | not reported in cached trials |
| Mitochondrial dna mutation | 30 | 869.5 557.5–1,356.2ROR 871.5 · χ² 16,282 / p <1e-300 | 413.9 EB05 303.9 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious n=30 · ♀ 100% (drug 60%) | not reported in cached trials |
| Neonatal intestinal perforation | 12 | 797.0 398.7–1,593.4ROR 797.8 · χ² 5,840 / p <1e-300 | 287.9 EB05 175.5 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=12 | not reported in cached trials |
| Csf oligoclonal band present | 20 | 315.7 195.4–509.8ROR 316.1 · χ² 4,977 / p <1e-300 | 210.8 EB05 144.1 · IC025 +4.4 3/3 methods agree | Lab value / disease marker | serious n=20 · 90% clinician | not reported in cached trials |
| Delivery | 108 | 315.3 256.7–387.3ROR 317.9 · χ² 27,989 / p <1e-300 | 251.7 EB05 214.3 · IC025 +6.6 3/3 methods agree | Not in label — unassessed | serious n=107 · ♀ 100% (drug 60%) | not reported in cached trials |
| Hypermagnesaemia | 91 | 267.6 214.5–334.0ROR 269.5 · χ² 20,471 / p <1e-300 | 218.8 EB05 183.6 · IC025 +6.3 3/3 methods agree | Not in label — unassessed | serious n=87 · ♀ 90% (drug 60%) · 100% clinician | not reported in cached trials |
| Burkholderia test positive | 16 | 238.4 141.0–403.0ROR 238.7 · χ² 3,087 / p <1e-300 | 166.6 EB05 108.7 · IC025 +4.0 3/3 methods agree | Lab value / disease marker | serious n=10 | not reported in cached trials |
| Negative pressure pulmonary oedema | 11 | 216.5 115.3–406.3ROR 216.7 · χ² 1,892 / p <1e-300 | 143.7 EB05 85.7 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=11 | not reported in cached trials |
| Female genital tract fistula | 162 | 168.0 143.0–197.4ROR 170.1 · χ² 24,182 / p <1e-300 | 149.4 EB05 131.1 · IC025 +6.4 3/3 methods agree | Not in label — unassessed | serious n=162 · ♀ 100% (drug 60%) | not reported in cached trials |
| Airway peak pressure increased | 13 | 151.3 85.7–267.1ROR 151.4 · χ² 1,638 / p <1e-300 | 115.3 EB05 71.7 · IC025 +3.6 3/3 methods agree | Lab value / disease marker | serious n=13 | not reported in cached trials |
| Pco2 increased | 50 | 121.1 90.9–161.4ROR 121.6 · χ² 5,425 / p <1e-300 | 108.1 EB05 85.2 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious n=50 · ♀ 100% (drug 60%) | not reported in cached trials |
| Neuromuscular blockade | 15 | 113.9 67.5–192.2ROR 114.0 · χ² 1,463 / p <1e-300 | 94.0 EB05 60.4 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=13 | not reported in cached trials |
| Radiculopathy | 164 | 107.2 91.6–125.4ROR 108.5 · χ² 16,068 / p <1e-300 | 99.4 EB05 87.2 · IC025 +6.0 3/3 methods agree | Not in label — unassessed | serious n=164 · ♀ 97% (drug 60%) | not reported in cached trials |
| Renal ischaemia | 32 | 101.2 70.8–144.6ROR 101.5 · χ² 2,892 / p <1e-300 | 90.2 EB05 66.9 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=32 · ♀ 100% (drug 60%) | not reported in cached trials |
| Po2 increased | 30 | 100.7 69.6–145.5ROR 100.9 · χ² 2,692 / p <1e-300 | 89.5 EB05 65.7 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=30 · ♀ 100% (drug 60%) | not reported in cached trials |
| Tachycardia foetal | 28 | 96.8 66.1–141.7ROR 97.0 · χ² 2,414 / p <1e-300 | 86.1 EB05 62.5 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=27 · ♀ 0% (drug 60%) · 100% clinician | not reported in cached trials |
| Chronic sinusitis | 205 | 93.6 81.3–107.6ROR 95.0 · χ² 17,646 / p <1e-300 | 87.7 EB05 78.1 · IC025 +6.0 3/3 methods agree | Not in label — unassessed | serious n=206 · ♀ 100% (drug 60%) | not reported in cached trials |
| Proctitis | 152 | 92.6 78.7–109.0ROR 93.7 · χ² 12,935 / p <1e-300 | 86.7 EB05 75.7 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious n=152 · ♀ 100% (drug 60%) | not reported in cached trials |
| Propofol infusion syndrome | 38 | 91.9 66.3–127.4ROR 92.2 · χ² 3,146 / p <1e-300 | 83.4 EB05 63.5 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=38 · ♀ 100% (drug 60%) | not reported in cached trials |
| Adrenal suppression | 45 | 91.0 67.4–122.9ROR 91.3 · χ² 3,706 / p <1e-300 | 83.2 EB05 64.7 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=45 · ♀ 0% (drug 60%) | not reported in cached trials |
| Blood magnesium increased | 48 | 90.7 67.8–121.2ROR 91.0 · χ² 3,943 / p <1e-300 | 83.1 EB05 65.2 · IC025 +5.0 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=30 · ♀ 100% (drug 60%) · 100% clinician | not reported in cached trials |
| Blood gases abnormal | 26 | 82.6 55.7–122.4ROR 82.7 · χ² 1,915 / p <1e-300 | 74.4 EB05 53.4 · IC025 +4.3 3/3 methods agree | Lab value / disease marker | serious n=26 · ♀ 100% (drug 60%) | not reported in cached trials |
| Apgar score low | 56 | 73.1 56.0–95.5ROR 73.4 · χ² 3,740 / p <1e-300 | 68.4 EB05 54.6 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=54 · 100% clinician | not reported in cached trials |
| Neuromuscular block prolonged | 16 | 72.7 44.0–119.9ROR 72.8 · χ² 1,014 / p 8e-223 | 64.4 EB05 42.1 · IC025 +3.7 3/3 methods agree | Labeled (related wording) related wording | serious n=13 | not reported in cached trials |
| Status asthmaticus | 19 | 66.9 42.3–105.8ROR 67.0 · χ² 1,121 / p 5e-246 | 60.5 EB05 40.9 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=19 | not reported in cached trials |
| Macular degeneration | 463 | 65.3 59.6–71.6ROR 67.7 · χ² 28,127 / p <1e-300 | 62.6 EB05 58.0 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious PRR 43.2 · ♀ 100% (drug 60%) | not reported in cached trials |
| Respiratory tract infection bacterial | 19 | 63.8 40.3–100.8ROR 63.9 · χ² 1,069 / p 9e-235 | 58.0 EB05 39.2 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=19 | not reported in cached trials |
| Hellp syndrome | 23 | 62.5 41.2–94.7ROR 62.6 · χ² 1,280 / p 1e-280 | 57.4 EB05 40.3 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=23 · ♀ 100% (drug 60%) · 100% clinician | not reported in cached trials |
| Pleocytosis | 20 | 57.8 37.0–90.2ROR 57.8 · χ² 1,022 / p 1e-224 | 53.1 EB05 36.3 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=20 | not reported in cached trials |
| Bradycardia foetal | 28 | 57.2 39.3–83.4ROR 57.3 · χ² 1,439 / p <1e-300 | 53.4 EB05 38.8 · IC025 +4.2 3/3 methods agree | Labeled (related wording) related wording | serious n=28 · 100% clinician | not reported in cached trials |
| Blood ph decreased | 57 | 55.4 42.5–72.1ROR 55.6 · χ² 2,889 / p <1e-300 | 52.7 EB05 42.1 · IC025 +4.8 3/3 methods agree | Lab value / disease marker | serious n=57 · ♀ 100% (drug 60%) | not reported in cached trials |
| Eclampsia | 12 | 55.1 31.0–98.0ROR 55.2 · χ² 565 / p 3e-125 | 49.4 EB05 30.1 · IC025 +3.1 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=12 | not reported in cached trials |
| Intraventricular haemorrhage neonatal | 16 | 54.7 33.3–90.1ROR 54.8 · χ² 765 / p 1e-168 | 50.0 EB05 32.6 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=16 | not reported in cached trials |
| Diabetes insipidus | 79 | 54.5 43.6–68.1ROR 54.8 · χ² 3,960 / p <1e-300 | 52.1 EB05 43.1 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=79 | not reported in cached trials |
| Neonatal infection | 11 | 53.0 29.1–96.6ROR 53.0 · χ² 494 / p 1e-109 | 47.4 EB05 28.2 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=11 | not reported in cached trials |
| Low birth weight baby | 249 | 52.3 46.1–59.2ROR 53.3 · χ² 12,077 / p <1e-300 | 50.4 EB05 45.4 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious PRR 32.7 · 98% clinician | not reported in cached trials |
| Maternal exposure during delivery | 30 | 51.5 35.8–74.0ROR 51.6 · χ² 1,390 / p <1e-300 | 48.5 EB05 35.6 · IC025 +4.2 3/3 methods agree | Reporting / coding artifact | serious n=25 · ♀ 100% (drug 60%) · 100% clinician | not reported in cached trials |
| Postpartum haemorrhage | 38 | 48.2 34.9–66.5ROR 48.3 · χ² 1,659 / p <1e-300 | 45.8 EB05 34.8 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=38 · ♀ 100% (drug 60%) · 100% clinician | not reported in cached trials |
| Foetal heart rate deceleration abnormality | 20 | 47.3 30.3–73.8ROR 47.4 · χ² 836 / p 4e-184 | 44.2 EB05 30.2 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=20 | not reported in cached trials |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Magnesium Sulfate as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (0 of 40 signal terms matched).
- NCT00059332 — Field Administration of Stroke Therapy - Magnesium (FAST-MAG) Trial (N=1700, PHASE3; 221 AE terms posted; arms: Normal Saline; Magnesium Sulfate)
- NCT01099449 — Calcium Gluconate and Magnesium Sulfate in Preventing Neurotoxicity in Patients With Colon Cancer or Rectal Ca (N=362, PHASE3; 150 AE terms posted; arms: Calcium Gluconate + Magnesium Sulfate (P; Placebo (Pre and Post); Calcium Gluconate + Magnesium Sulfate (P)
Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Drug ineffective (drug did not work) | 1,226 | 1.5 1.4–1.6ROR 1.6 · χ² 221 / p 2e-50 | 1.5 EB05 1.4 · IC025 +0.5 | Reporting / coding artifact | serious PRR 2.5 | not reported in cached trials |
| Off label use (used outside approved label) | 849 | 1.6 1.5–1.7ROR 1.6 · χ² 189 / p 3e-43 | 1.6 EB05 1.5 · IC025 +0.5 | Reporting / coding artifact | serious PRR 1.7 | not reported in cached trials |
| Nausea | 846 | 1.7 1.6–1.9ROR 1.8 · χ² 272 / p 2e-61 | 1.7 EB05 1.6 · IC025 +0.7 | Not in label — unassessed | serious PRR 2.0 | NCT01099449: 3/117 (2.6%) on Magnesium Sulfate; 3/116 (2.6%) control (serious AE) |
| Pyrexia (fever) | 795 | 3.7 3.5–4.0ROR 3.9 · χ² 1,600 / p <1e-300 | 3.7 EB05 3.5 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 2.9 | NCT00059332: 2/857 (0.2%) on Magnesium Sulfate (serious AE) |
| Maternal exposure during pregnancy | 757 | 14.0 13.0–15.0ROR 14.8 · χ² 9,073 / p <1e-300 | 13.9 EB05 13.1 · IC025 +3.7 3/3 methods agree | Reporting / coding artifact | serious PRR 10.4 · ♀ 97% (drug 60%) · 94% clinician | not reported in cached trials |
| Pain | 716 | 1.9 1.8–2.0ROR 1.9 · χ² 304 / p 3e-68 | 1.9 EB05 1.8 · IC025 +0.8 | Not in label — unassessed | serious PRR 1.8 | NCT00059332: 1/857 (0.1%) on Magnesium Sulfate (serious AE) |
| Foetal exposure during pregnancy | 684 | 13.7 12.7–14.8ROR 14.4 · χ² 8,013 / p <1e-300 | 13.6 EB05 12.8 · IC025 +3.6 3/3 methods agree | Reporting / coding artifact | serious PRR 8.8 · 96% clinician | not reported in cached trials |
| Premature baby | 672 | 36.8 34.1–39.6ROR 38.7 · χ² 22,861 / p <1e-300 | 35.9 EB05 33.7 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious PRR 23.1 · 96% clinician | not reported in cached trials |
| Diarrhoea (diarrhea) | 658 | 1.7 1.5–1.8ROR 1.7 · χ² 175 / p 3e-40 | 1.7 EB05 1.5 · IC025 +0.6 | Not in label — unassessed | serious PRR 1.7 | NCT00059332: 1/857 (0.1%) on Magnesium Sulfate (serious AE) |
| Dyspnoea (shortness of breath) | 610 | 1.7 1.6–1.9ROR 1.8 · χ² 198 / p 3e-45 | 1.7 EB05 1.6 · IC025 +0.7 | Not in label — unassessed | serious PRR 1.4 | NCT00059332: 34/857 (4.0%) on Magnesium Sulfate (serious AE) |
| Hypotension (low blood pressure) | 561 | 4.5 4.2–4.9ROR 4.7 · χ² 1,554 / p <1e-300 | 4.5 EB05 4.2 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.3 | NCT00059332: 59/857 (6.9%) on Magnesium Sulfate (serious AE) |
| Anaemia (low red blood cells) | 559 | 4.7 4.4–5.1ROR 4.9 · χ² 1,659 / p <1e-300 | 4.7 EB05 4.4 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 3.3 | NCT00059332: 12/857 (1.4%) on Magnesium Sulfate (serious AE) |
| Vomiting | 530 | 1.8 1.7–2.0ROR 1.9 · χ² 202 / p 3e-46 | 1.8 EB05 1.7 · IC025 +0.7 | Not in label — unassessed | serious PRR 1.7 | NCT00059332: 1/857 (0.1%) on Magnesium Sulfate (serious AE) |
| Pneumonia (lung infection) | 490 | 2.5 2.2–2.7ROR 2.5 · χ² 426 / p 6e-95 | 2.4 EB05 2.3 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 1.6 | NCT00059332: 36/857 (4.2%) on Magnesium Sulfate (serious AE) |
| Fatigue (tiredness) | 480 | 1.0 0.9–1.1ROR 1.0 · χ² 0 / p 0.498 | 1.0 EB05 0.9 · IC025 -0.2 PRR-only: not supported by EBGM or IC | Labeled (related wording) related wording | serious PRR 1.0 | NCT00059332: 1/857 (0.1%) on Magnesium Sulfate (serious AE) |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Normal labour — n=107, PRR 5,330.1
- Vaginal flatulence — n=153, PRR 1,636.9
- Mitochondrial dna mutation — n=30, PRR 869.5
- Delivery — n=108, PRR 315.3
- Hypermagnesaemia — n=91, PRR 267.6
- Female genital tract fistula — n=162, PRR 168.0
- Pco2 increased — n=50, PRR 121.1
- Radiculopathy — n=164, PRR 107.2
- Renal ischaemia — n=32, PRR 101.2
- Po2 increased — n=30, PRR 100.7
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Magnesium Sulfate?
In FDA FAERS, the most frequently co-reported reaction terms for Magnesium Sulfate are nausea, pyrexia, pain, premature baby, diarrhoea, dyspnoea. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Magnesium Sulfate have an FDA boxed warning?
No. The FDA label retrieved for Magnesium Sulfate has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Magnesium Sulfate causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 8da9c33f-e3cd-4026-b034-2b964401b346, effective 20260112; matched on
openfda.generic_name.exact:"MAGNESIUM SULFATE" AND openfda.product_type:"HUMAN PRESCRIPTION DRUG") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 1,159 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath - ClinicalTrials.gov API v2 (query
MAGNESIUM SULFATE, results-bearing studies sorted by enrollment)
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.